BioTOP-Report. Biotech and Pharma in Berlin-Brandenburg

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1 BioTOP-Report 2013 Biotech and Pharma in Berlin-Brandenburg

2 BioTOP-Report Content Editorial Unique Chances to Create Value in Biotechnology and Life Sciences 3 Biotechnology More Companies, More Employees and New Deals 4 Pharma The German Capital Region: Highly Attractive for the Pharmaceutical Industry 14 Diagnostics An Excellent Location for the Development of Innovative Diagnostics 18 Industrial Biotechnology Focus: Biopolymers and Bio-based Plastics 22 Global Business New Markets and Horizons for Global Business 25 Business Location Excellent Services for Berlin-Brandenburg 28 Technology Transfer Technology Transfer between Science and Business 30 Life Sciences A Science and Research Hub 34 Know-how in Systems Medicine and Systems Biology 36 Biotech Biotech Parks The BioCampus Network Berlin-Brandenburg 50 Addresses 55 Publisher: Berlin Partner für Wirtschaft und Technologie GmbH BioTOP Berlin-Brandenburg Fasanenstraße Berlin Germany Phone Fax [email protected] Editor: Yvonne Küchler Design & Production: supiran.de Translation: Textbüro Reul GmbH Frankfurt Photos/Figures: BioTOP or Authors and: Page 10 Ralfpoller*, Wladimir Bulgar*; Page 13 Werner Popp (Profile organobalance), Vanillla * (Profile BPI); Page 14 Phartisan*, Idrutu*; Page 18 Stratum*, Stanislav Perov*; Page 20 Alx, fotolia.com (Profile Dr. Nothgi); Page 22 BASF; Page 25 C. Keating*, Moth*; Seite 32 Bayer HealthCare; Page 33 Eric1513*, Jankaliciak*, Grafoo*, Eraxion*, Kjpargeter*, Andrey Armyagov*; Page 37 Christoph Heidrich; Page 40 Illustration: webersupiran, photo Sofiaworld *; Page 41 Paulus Rusyanto*, Collpicto*, 18percentgrey*; Page 46 Natalia Pavlichenko*/Patho (Profile Predemtec) *dreamstime.com

3 BioTOP-Report Editorial The German Capital Region Unique Chances to Create Value in Biotechnology and Life Sciences In an emerging health environment, manufacturers of drugs, diagnostics and devices will need to be able to prove not only the safety and efficacy but also the value of their products. Thus all players in the value chain reaching from scientific institutions and biotech companies to clinics and healthcare providers are rethinking their products, services and business models. They find perfect conditions in Berlin-Brandenburg. Dr. Kai Bindseil Cluster Manager HealthCapital Director BioTOP Berlin-Brandenburg Obviously, most participants in the value chain have realised that cooperation is the most important factor for success and are shaping their cooperation strategies: kkcross-innovation at the interface of life sciences, information technology and engineering takes place everywhere. This innovation sector will not only create value through new tools and cost reduction in healthcare delivery, but also enable all of us to take control of our own health and wellness. The most recent example is the Joint Lab for Bioelectronics of the Technische Universität Berlin and the Leibniz Institute for Microelectronics. Berlin-Brandenburg is indeed the European hotspot for collaboration. More than 200 biotechnology and 30 pharmaceutical companies benefit from close cooperation with five universities and more than a dozen institutes of the Helmholtz, Max Planck, Fraunhofer and Leibniz societies and associations, as well as more than 130 hospitals among them Europe s largest university hospital: Charité Universitätsmedizin Berlin. As a consequence, the sector has grown more than 6% in 2012 and is growing continuously since 10 years. This fertile ground will be further strengthened with the new master plan for the healthcare industry. BioTOP is pleased to present the most important developments in life sciences, pharma and biotechnology in our new annual report. We hope you enjoy reading our report, and we invite you to play an active role in one of the most vibrant European life sciences networks. Don t hesitate to contact us. kkbasic and clinical research of the Max Delbrück Center of Molecular Medicine (MDC) and the Charité Universitätsmedizin Berlin will come together in the Berlin Institute of Health (BIH) to create the new flagship of German life sciences. Dr. Kai Bindseil kkscientific excellence and development experience will team up in the CoLaborator, established by Bayer to incubate startups. kkentrepreneurial skills will be strengthened in the Entrepreneurial Network University of the Freie Universität Berlin, Charité and several companies. 3

4 BioTOP-Report Biotechnology More Companies, More Employees and New Deals The positive development of the regional corporate landscape got new momentum in The number of employees in the sector rose by 6.5 %. Compared to average growth rates of 3.5% during recent years, this has been a clear and very welcome sign of the dynamism in the Berlin-Brandenburg region, where 222 companies now employ a workforce numbering 4,348 people. Development of the Companies in 2012 BioTOP conducted its anual survey of regional companies for the year 2012 to obtain a comprehensive overview of the current development of the corporate scene. During 2012, twelve new companies joined the ranks of surveyed companies, of which nine were newly founded and three included in the survey for the first time. Five companies ceased operations or moved to a different region. The new companies are still smaller firms focusing on services and product development in the field of biomedicine. As an example, we refer to t-cell Europe, which received funding from the High-Tech Gründerfonds (HTGF). The aim of t-cell Europe, a spin-off of the Berlin-Brandenburg Centre for Regenerative Therapies, is to use its patented platform technology to develop and market new t-cell-based regenerative therapies. The company s first reference product will be a t-cell product for kidney transplants. Another interesting start-up is Drug Response Dx GmbH in Hennigsdorf. DRDx is developing a robust companion diagnostic test which permits secure stratification regarding failure in TNFα blocker (TBA) therapy for rheumatism patients and therefore addresses a very big market. The sizes of companies barely changed during the past few years. Smaller enterprises with less than ten employees make up 63% of all companies, but these firms also account for only app. 15% of all employees. More than 54% of those employed in the regional biotech sector work in the 19 companies with more than 50 employees. The thematic focus of the industry also remained unchanged during recent years and continues lie on biomedicine, and here particularly diagnostics. MARCH BIONNALE in Berlin 10 years of success Biggest biotech industry meeting in Berlin-Brandenburg celebrates its jubilee APRIL 2012 NOXXON's NOX-A12 delays recidivation in preclinical glioblastoma model ++++ Epigenomics AG enrolls first participant in its FIT comparative study with Epi procolon MAY 2012 MOLOGEN AG: Promising start in financial year 2012, quarterly record presented ++++ ifp and Romer Labs join in world-wide sales cooperation for EnzymeFast food test kits JUNE 2012 ORGANOBALANCE presents new research results on ACHEMA 2012: Extended application range for yeast strains in biotechnological production ++++ CellTrend GmbH and One Lambda Inc. agree to world-wide sales contract ++++ United States Patent and Trademark Office grants co.don AG patent for production of autologous spinal disc cell transplants ++++ NOXXON initiates phase IIa study of anti-ccl2/mcp-1 Spiegelmer NOX-E36 for treatment of diabetic neuropathy ++++ ATLAS Biolabs extends spectrum of services by Variant AnalysisTM and ireporttm by Ingenuity Systems for data analysis and interpretation JULY 2012 Epigenomics appreciates reimbursement of Septin-9 blood test for early recognition of colon cancer by Swiss Life in France ++++ MOLOGEN AG capital increase of 22 million Euros AUGUST 2012 co.don AG reaches another milestone on the path to central approval; Recruitment phase for clinical phase II trial completed successfully ++++ Merck buys Biochrom AG ++++ Indian pharma firm Piramal invests in molecular imaging in Germany SEPTEMBER 2012 Epigenomics AG announces changes in executive board ++++ Charité and Sanofi extend partnership by diabetes alliance ++++ MOLOGEN AG: Current data of kidney cancer therapy MGN1601 shows further improved results OCTOBER years Klosterfrau Berlin GmbH ++++ ATLAS Biolabs takes part in European projects on the research of DNA repair and cell aging ++++ co.don AG from Teltow presents gentle alternative preserve joints instead of replacing them 4

5 BioTOP-Report Biotechnology Deals and Product Developments Dr. Claudia Ulbrich CEO t-cell Europe GmbH Our T-cell-based therapies, unique throughout the world, can help prevent organ rejection following transplant procedures, thus significantly reducing the need for immunosuppressive drugs. With the new funds of EUR 5.5 million raised in our most recent financing round, we aim to commence clinical trials already in 2014, so that we can expeditiously move forward with proof-of-concept at the patient level, then proceed with negotiations to license our proprietary technology to a pharmaceutical industry partner. T-cell therapy will not completely eliminate the need for immunosuppressive support. However, even if the amount of immunosuppressive drugs required can be reduced by one half, the costs of our therapy will be quickly recovered, generating net patient savings. Just for one specific application, T reg therapy following kidney transplantation, we estimate a current market potential of more than one billion euros per year. A number of companies closed new cooperation agreements in 2012 and achieved major milestones in product development and approval. We present some examples of these dynamic activities: MOLOGEN presented outstanding results in its clinical development programmes from a first evaluation of the colon cancer study with the active pharmaceutical ingredient MGN1703. The evaluation performed in May 2012 demonstrated the effectiveness of MGN1703 as a maintenance therapy for metastasised colon cancer impressively. MOLOGEN also plans to investigate the effect of MGN1703 in lung cancer therapy in the future. In October 2012, the company presented promising new data from its kidney cancer study with MGN1601. They showed a clear survival advantage for patients who fully completed the prescribed therapy programme compared to patients who had to terminate the therapy early due to the severity of their cancer disease. Furthermore, MOLOGEN completed the preclinical phase of its MIDGE -based Leishmaniasis vaccine MGN1331 in June 2012 with good results. NOVEMBER 2012 Alacris Theranostics GmbH signs agreement with GSK to apply Alacris Mod- CellTM system in the early phase of cancer research ++++ Entry to the pharma market: Tönnies invests 21 million Euro, majority shareholder at Heparin specialist Pharma Action DECEMBER 2012 NOXXON initiates phase IIa study on anaemia of chronical illness with anti- Hepcidin Spiegelmer NOX-H Epigenomics releases more data on the results of a direct comparative study between Epi ProColon and FIT JANUARY 2013 Epigenomics AG hands in fourth module at FDA completes application for approval as planned ++++ co.don AG applied for approval of joint cartilage product chondrosphere in the EU ++++ Shire discovered the Munich-based RNA specialist Ethris for itself. In cooperation the two companies want to find therapies for rare diseases MARCH 2013 BIOTECON Diagnostics GmbH extends its robot segment ++++ Epigenomics AG collects 5,0 million Euros through capital increase ++++ New research collective INNO-TRACE develops innovative contrast agents for tumour imaging APRIL 2013 Europe's largest clinical laboratory at Campus Virchow-Klinikum: Labor Berlin inaugurates new site MAY 2013 Bayer HealthCare presents new incubator model for biotech start-ups in Berlin JUNE 2013 Alacris Theranostics GmbH announces Illumina CSPro certificate for next generation sequencing ++++ Humedics co-founder Martin Stockmann receives Von-Langenbeck Prize for development of LiMAx test FEBRUARY 2013 Epigenomics receives notice about grant of priority review status and acceptance of the hand-in of the PMA application for Epi procolon from the FDA ++++ Innovation forum Biopolymers and Bio-based Plastics in Schwarzheide 5

6 BioTOP-Report Biotechnology NOXXON Pharma AG, a biopharmaceutical company and pioneering developer of the new active agent class spiegelmers, successfully advanced its product pipeline. Its latest candidate agent NOX-H94 is already the third spiegelmer to have reached the Phase II trial stage. This is one of four Phase IIa trials NOXXON began in The others are investigating NOX-E36 in diabetic nephropathy therapy, NOX-A12 in the therapy of chronic lymphatic leukaemia and NOX-A12 for treatment of multiple myeloma. The trial for anaemia of this chronic disease is the fourth Phase II trial NOXXON launched in The German-American molecular diagnostics corporation Epigenomics AG made important progress with the approval of Epi procolon in the USA and the development of its marketing strategy for this blood-based test for early detection of colon cancer. The next major milestone will now be the marketing launch of the product on the world s most important market the USA. Number of Employees According to Company Size Number of employees '03 '04 '05 '06 '07 '08 '09 '10 '11 '12 '03 '04 '05 '06 '07 '08 '09 '10 '11 '12 '03 '04 '05 '06 '07 '08 '09 '10 '11 ' companies 1-10 employees 61 companies employees 20 companies > 51 employees In comparison to the previous year, the average number of employees per company increased by 2,7 % in the 1-10 category and 1,8 % in the category. The average number of employees in the category > 50 employees increased by 10%. (Source: Own survey, BioTOP database, 222 companies questioned, June 2013) 6

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8 BioTOP-Report Biotechnology Epigenomics also found a new partner in BioChain, a leading clinical diagnostics provider for oncological and genetic tests. This company will offer Epigenomics customers the Septin9 test through its independent Chinese reference laboratory in Beijing and thereby prepare the ground for Epigenomics market entry in China. The Institut für Produktqualität (ifp) and Romer Labs, a globally leading company in the field of food diagnostics, have agreed on the joint launch of a new product line for enzymatic food analytics. The two companies are expanding their existing cooperation with this global marketing collaboration. The new Enzyme- Fast product line transfers the traditional enzymatic methods to a microtiter plate kit format, thereby providing a significant advantage in routine food analytics. CellTrend GmbH announced its partnership with the American company One Lambda Inc. The aim of this cooperation is to supply transplantation centres worldwide with innovative diagnostic products developed by CellTrend. Under the agreement, One Lambda will receive the exclusive global distribution license for the immunoassay EIA for quantitative determination of anti-angiotensin II-receptor 1 antibodies (AT1R). AT1R is involved in a range of neurohumoral systems and expressed in many organs, including the heart, liver, lung and kidneys. The Indian corporation Piramal took over the molecular imaging pipeline of Bayer Healthcare in April The acquired PET radiopharmaceuticals have been researched and developed further since then in the Berlin laboratories of Piramal Imaging. The portfolio also includes the rights to florbetaben, a highly specific substance for determination of beta-amyloid deposits in the brain, which is a marker for Alzheimer s disease. A Phase-III trial of florbetaben was completed successfully. With the development of its innovative PET radiopharmaceuticals for molecular imaging, Piramal is focused on a key future field in modern medicine. Alacris Theranostics GmbH closed an agreement with GlaxoSmithKline (GSK) which entitles GSK to use the proprietary ModCellTM system of Alacris for pharmaceuticals stratification with its own data from the early stages of cancer research at GSK. The system was developed at the Max Planck Institute for Molecular Genetics and licensed exclusively to Alacris. Dr. Ludger Dinkelborg Managing Director of Piramal Imaging GmbH co.don AG in Teltow, one of the leading manufacturers of endogenous cartilage cell transplants for the treatment of joint and disc damage, achieved a further milestone on the road to central approval. Recruitment for the clinical Phase-II trial was successfully completed in June In this clinical long-term study, 75 patients with cartilage defects in the knee joint were treated with co.don chondrosphere, an endogenous matrix-associated transplant of patient cartilage cells. The extensive approval documentation was filed with the European pharmaceuticals agency EMA in London at the end of the year. Biochrom AG announced that Merck closed a definitive agreement on the acquisition of Biochrom AG on 22 August The acquisition is subject to the usual preconditions for execution such as approval by the competent anti-trust authority. The Berlin location of Biochrom AG is being retained. The activities of Biochrom are being integrated into the Process Solutions business unit of Merck Millipore. In the Piramal Group s cluster-based thinking, the Berlin location unequivocally represents know-how and a long tradition in the field of diagnostic imaging. After all, this is where the first contrast medium was invented back in the 1930s. There is top personnel here: the training situation is excellent, both in companies like Bayer and in the local academic institutions. We collaborate closely with eminent experts from Charité hospital a key partner for clinical trials - in the field of molecular imaging and in the diagnosis of Alzheimer s disease In the capital region are many small companies in the fields of radiopharmaceuticals and diagnostics, and many service providers supporting clinical research. Berlin is a global metropolis offering a high quality of life, the kind of place where people like to live and work. That makes it easy to recruit international experts. 8

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10 BioTOP-Report Biotechnology GLYCOTOPE moved two products into Phase II clinical development. After successfully completing Phase I of its glyco-optimised therapeutic antibody PankoMabTM, the company moved the compound to Phase II clinical development in ovarian cancer, with further indications planned. After successful completion of Phase I, GLYCOTOPE also advanced its glyco-optimised therapeutic protein FSH-GEXTM into Phase II clinical development in in-vitro fertilisation. The Financing Situation The financial position of the region s biotech industry is stable overall, and the consolidation efforts during recent years are now paying off. The business models of most companies are commercially feasible and generating free funds for investments and growth. Companies with high capital needs successfully acquired new funds for their product developments or market approvals in Capital increases of listed companies alone injected more than 40 million into the respective companies, headed by MOLO- GEN AG, which generated 25 million. Apart from these public placements, there were no major financing events with two exceptions: The first outstanding exception was the takeover of the molecular imaging pipeline of Bayer Healthcare by the Piramal Group into the newly founded company Piramal Imaging. Europe s leading pork marketing company Tönnies joined the ranks of financially strong private investors in the pharmaceuticals sector. Tönnies acquired the majority in the company Pharma Action in Berlin. The companies aim to manufacture the coagulation inhibitor heparin jointly in future. This active substance is obtained from the intestinal mucus of pigs and administered to patients during operations or in the case of cardiac illness. Private venture capital transactions were not significant. Once more, the most active investor was IBB Beteiligungsgesellschaft with two first and two follow-up investments and the HTGF with two start-up funding investments. It should be noted that these are both public-sector investors. The private VC business remains dissatisfying. It is therefore time to create new drivers and incentives for venture capital. Public-sector institutions remain very important to the financing of product developments and investments. The two states Berlin Employees in Biotech SMEs Number of employees '03 '04 '05 '06 '07 '08 '09 '10 '11 '12 Employment rose to in This is a growth of 6,5% in comparison to the previous year. The number of companies went up to 222, reflecting the arrival of 10 companies and five departures. (Source: Internal survey, BioTOP database, 222 companies questioned, June 2013) 10

11 BioTOP-Report Biotechnology and Brandenburg alone disbursed more than 37 million in support funds to regional life sciences companies, while the German federal government provided a similar amount of project support funding. The leverage effect of these funds resulted in private investments of comparable dimensions. When compared to purely private investments, it is clear how important public funding programmes are to permit new product developments and as a multiplier for private fundings. Conclusion obtaining it successfully, thereby demonstrating that investments in the life sciences are attractive for both institutional and private investors. Apart from public-sector portfolio investors, however, the venture capital market remains weak a phenomenon that has been observable for many years. Although it is good and proper that the regional and federal governments support the research and development of innovative and promising projects with appropriate funds and thereby secure highly qualified jobs for the future, the commitment of private investors and the associated conditions must be developed further and improved. Overall, the economic and financial situation of the regional biotech industry is solid. Most companies are financing themselves with own funds, while companies requiring external capital are Market Segments of Companies % Number of companies 30 14% 40 18% 0 '03 '04 '05 '06 '07 '08 '09 '10 '11 '12 '03 '04 '05 '06 '07 '08 '09 '10 '11 '12 '03 '04 '05 '06 '07 '08 '09 '10 '11 '12 Agriculture/Food White Biotechnology /Environmental Biotechnology Biomedicine Most companies focus on biomedicine. A total of 83 % of companies, focus primarily on development in the areas of new diagnostics, drug development and associated services or technologies. 14 % of the companies are active in the agriculture / food sector, white biotechnology / environmental biotechnology amounts to 18 % of all entries. (Source: Internal survey, BioTOP database, responses from 222 companies, multiple entries, June 2013) 11

12 BioTOP-Report Metanomics Health GmbH Metanomics Health a BASF Group company applies comprehensive Metabolite Profiling (metabolomics) with biomedical data interpretation. Metabolite Profiling is defined as the parallel analysis of multiple endogenous and xenobiotic metabolites in biological systems. The core expertise of Metanomics Health resides in discovery and validation of biomarkers. Technologies kkmetabolite profiling platform with more than 75 GC-MS and LC-MS/MS instruments kkwide metabolite coverage via combination of unbiased and targeted platforms kkunique tox mode of action prediction through MetaMap Tox database kkexcellence in systems correlation analysis of complex gene function relationships Major R&D-Topics In cooperation with academic institutes and clinical experts Metanomics Health is running a large-scale diagnostic biomarker program. Areas include metabolic syndrome, heart failure, prostate cancer and multiple sclerosis to mention a few. Market Segments Metanomics Health provides its services to pharmaceutical, diagnostics and nutrition companies. Technology applications include: kkmechanism of action studies kkmechanism of toxicity studies kktranslational and clinical biomarker development (e.g. PK/PD, patient stratification, efficacy and safety markers) kkcompanion diagnostic development kkcell culture & bioprocess optimization Address Metanomics Health GmbH Tegeler Weg Berlin Germany Contact Dr. Tim Bölke Managing Director Phone Fax [email protected] nanopet Pharma GmbH nanopet is a biopharmaceutical company specialized on R&D, manufacturing and marketing of innovative drug substances for Diagnostic Imaging. We focus on relevant cardiovascular, oncological and neurological indications as well as on regenerative medicine. Nanotechnology is a key element of our business. We operate in three major areas. The first nanoparticular tracers for clinical PET: nanopet prepares the clinical development of its patented technology platform: inorganic nanoparticular tracers for cell- and molecular-specific positron emission tomography (PET). Viscover imaging agents a landmark in small animal imaging: As animal imaging is rapidly gaining relevance in pharmaceutical research, we are delighted to offer you an exciting portfolio of specialized preclinical imaging agents covering the principal imaging modalities (MRI, CT, Ultrasound, Optical Imaging, SPECT & PET). Get a detailed insight into our product portfolio and download a free copy of our imaging guide on long-standing industry expertise our team has attained in the pharmaceutical research & development. Address nanopet Pharma GmbH Robert-Koch-Platz Berlin Germany Contact Dr. Andreas Briel CEO Phone [email protected] Consulting and Service tailored to your needs: As a technology and service provider, we offer our expertise to biopharmaceutical companies and imaging equipment manufacturers. Our customers benefit from the 12

13 BioTOP-Report ORGANOBALANCE GmbH Exploring and managing microbial biodiversity ORGANOBALANCE explores the potential of probiotic bacteria and yeasts for new product developments in food, feed, personal care, and for the pharmaceutical industry or the production of fine chemicals. From a large collection of microorganisms, specific strains are selected to e.g. inactivate pathogens, produce new bioactives, neutralize malodorous or toxic substances and synthesize high titers of valuable compounds. ORGANOBALANCE draws on natural resources, which are gathered in the company-owned collection of microbial strains, mostly originating from foodstuffs. ORGANOBALANCE uses its OASSYS bioassays for highly efficient screenings. The platform allows to quickly identify the most suitable strains from the microbial collection for targeted applications. ORGANOBALANCE has a broad expertise in the field of yeast metabolic engineering. This includes designing and developing new production strains for industrial biotechnology applications. Specific strains of Saccharomyces cerevisiae, which carry engineered biosynthesis pathways for the environmentally friendly production of carboxylic acids, terpenoids, steroids and other lipid compounds are available. ORGANOBALANCE works in collaboration with partners and grants licenses for own product developments. Address ORGANOBALANCE GmbH Gustav-Meyer-Allee Berlin Germany Contact Dr. Christine Lang CEO Phone Fax [email protected] Our experience is your success! The German Pharmaceutical Industry Association (BPI Bundesverband der Pharmazeutischen Industrie e.v.) consists of approximately 240 pharmaceutical companies. These include not only the classic pharmaceutical firms and service-providers, but also biotechnology companies and manufacturers of medical devices. All of our members use our association as a platform for information and communication to develop collaborative responses to the diverse challenges they face. Our team consists of highly qualified experts in all fields which are necessary to generate a sustainable benefit for pharmaceutical companies, e.g. market access, regulatory affairs, law, biotechnology and political affairs. Interested in being a member? Feel free to contact us! [email protected] Phone: Start Up-Companies are eligible for reduced membership fees while having the possibility to participate in all activities of our association. 13

14 BioTOP-Report Pharma The German Capital Region: Highly Attractive for the Pharmaceutical Industry The pharmaceutical industry is an important economic factor and job motor in the German capital region. According to a study by the Cologne Institute for Economic Research 1 commissioned by the Association of Research-Based Pharmaceutical Companies (vfa), the number of people employed in the industry in Berlin grew since 2009, in contrast to the national trend. Whereas jobs in the pharmaceuticals sector declined by 2.6 % in Germany as a whole, in Berlin the number of employees grew by 1.5 % to 9,589. One in eleven employees in the German pharmaceutical industry works in Berlin. With sales worth 5.6 billion, Bayer, Berlin Chemie, Pfizer, Sanofi and the more than 20 other pharmaceutical manufacturers form the industry in the German capital with the highest revenues. With 17 % of Berlin s total industrial production, pharmaceutical companies come in first position, ahead of electrical engineering and mechanical engineering. Berlin-Brandenburg is a highly attractive location for pharmaceutical companies. International companies in the industry like Takeda, which recently arrived in Berlin, are not just attracted by Berlin as the German capital. The many research facilities, hospitals and biomedical companies in the region provide pharmaceutical companies with an infrastructure that will become increasingly important to them in future. The industry faces major challenges: stricter approval regulations for new active substances, declining prices, expiring patents and mounting competition from generics manufacturers present the need for new business strategies. The core terms often raised in this context are: personalised medicine and networks. Dr. Norbert Gerbsch Deputy Director General of the German Pharmaceutical Industry Association (BPI) A strong economic, medical and innovative basis and an excellent research landscape are important characteristics of a Health Capital with special relevance for pharmaceutical companies. Berlin and Brandenburg offer all of those characteristics. It is therefore not surprising that the number of pharmaceutical companies is steadily increasing: The region provides an extremely attractive surrounding for an industry which relies on qualified personnel and needs to reinvent itself in the face of the challenges of the biological revolution, demographic change, budgetary pressures in health systems, and health benefit assessment. And: The German capital region is a center for decision makers. As the German Pharmaceutical Industry Association, we are located here in order to participate thoroughly in the discussions about healthcare reforms and to maintain an ongoing dialogue with the public as well as other partners for the health sector Kirchhoff, Jasmina, Die Pharma-Industrie in Berlin: Ergebnisse der Mitgliederbefragung des Verbandes forschender Pharma-Unternehmen (vfa) Wirtschaftsdaten

15 Get Old Pfizer researches to develop the medicines of today and tomorrow We at Pfizer are committed to applying science and our global resources to improve health and well-being at every stage of life. We strive to provide access to safe, effective and affordable medicines and related health care services to the people who need them.

16 BioTOP-Report Pharma Personalised Medicine and Networks Many pharmaceutical and biotech companies in Berlin-Brandenburg are pursuing concepts in the field of personalised medicine and therefore present themselves as potential cooperation partners. For example, Alacris Theranostics GmbH specialises in the development of new processes in personalised medicine for cancer patients, focusing in particular on the development of new approaches in diagnostics, therapy and drug stratification. Metanomics Health, a BASF Group company, on the other hand, offers targeted and non-targeted metabolite profiling to healthcare customers in industry and academia. Alongside companies focussed on developing companion diagnostics, the region is home to many specialised service providers and subcontractors which concentrate on the early phases of pharmaceuticals development and are highly regarded internationally for their specialist know-how. Caprotech GmbH, whose Caprotecs Capture Compound Mass Spectrometry (CCMS) permits the function-specific isolation and identification of proteins, serves as an example. The system offers both the identification of the mechanism of action of a molecule and determination of its interaction partners, which may be responsible for side effects. Another biotech company, EPO GmbH, provides a unique and outstanding source for cancer research projects. They offer the right models for every preclinical development phase, from target identification and validation to translational research. In many of the region s academic institutions, research into a number of topics in personalised medicine is under way. The potential is huge and diverse, which makes it all the more important that it has now been concentrated and highlighted by the establishment of two new beacons. The first is the Berlin Institute of Health (BIH) which brings together the patient-focused research expertise of Charité Universitätsmedizin Berlin and the basic research of the Max Delbrück Centre for Molecular Medicine (MDC) even more closely than before in a joint institution. The second is the Integrative Research Institute (IRI) for the Life Sciences, which was founded in Berlin in early March 2013 and whose interdisciplinary work will extend from knowledge about life at the molecular level to complex organisms (see page 36). Jean-Luc Delay Managing Director Takeda Pharma Vertrieb GmbH & Co. KG As a global company, we want to be present in the German capital. Takeda is Japan's as well as Asia's largest pharmaceutical manufacturer, and Berlin offers several advantages to us: proximity to the governmental and regulatory bodies, to important industry associations such as the Association of Research-Based Pharmaceutical Manufacturers (vfa), and to other pharmaceutical companies. From Berlin, we direct all activities for the German market. And: one of our two production sites is also located in the Berlin region. The Takeda plant in Oranienburg is a state-of-the-art production facility for various types of tablets and capsules. Berlin-Brandenburg offers a broad portfolio of potential answers to the challenges facing the pharmaceutical industry, in particular with regards to the integration of different players from the science and biomedical services sectors in the early phases of development. The project OncoTrack is an impressive example. An Outstanding Network for Personalised Therapies OncoTrack is a consortium of more than 80 scientists that has launched one of Europe s largest collaborative research projects between academia and industry to develop and assess novel approaches for the identification of new markers for colon cancer. The project brings together top scientists from European academic institutions offering a wide range of expertise, and partners them with pharmaceutical companies. Consortium members from the Berlin-Brandenburg area play a vital role in the project, with six partners from clinics (Charité), non-university research institutes (Max Planck Institute for Molecular Genetics), the pharmaceutical industry (Bayer HealthCare Pharmaceuticals, Pfizer) and SMEs (Alacris Theranostics, EPO Experimental Pharmacology & Oncology). The goal of OncoTrack is to improve our understanding of the variable make-up of tumours and how it affects the way an individual patient responds to treatment. This project is one example how our understanding of the fundamental biology of colon cancer can be advanced and will open the door for personalised therapeutic management of cancer patients. 16

17 You need commitment, focus and passion to find new ways to fight the diseases of this world: innovation is at the heart of it. Innovation for better health. Our commitment is to bring to patients around the world quality medicines for use in diag nosing, combating and preventing disease. Every day we work against time, researching new pathways, new molecules, new technologies complementing our own capabilities with exper tise of innovative partners from science and industry. The success of this work is evidenced in new m e d i c i n e s for areas with significant unmet medicalneed such as oncology, cardiovascular and blood diseases, as well as gynecology and ophthalmology. Our aim is a better quality of life for all.

18 BioTOP-Report Diagnostics An Excellent Location for the Development of Innovative Diagnostics In Berlin-Brandenburg bioanalysis is a focus area of research and development. Some 100 companies and more than 20 research facilities present the entire value chain from biomarker identification through clinical validation to the production of in vitro-diagnostics. Early, specific and reliable laboratory diagnostics makes a key contribution to disease detection, therapy optimisation, and prevention. Its importance can therefore barely be overrated, given the many challenges facing our healthcare systems. Progress in biomedical basic research and the development of new analytical techniques and methods has resulted in a tremendous increase in the performance of diagnostic laboratories over the past decades. New sensor-actor molecules, autonomous biosensors, genome, proteome and glycan-based multiplex analytics as well as metabolomics platforms provide the foundation for the development and implementation of innovative biomarker strategies. Companion diagnostics for personalised medicine are rapidly gaining in importance based on these new insights and developments. In light of this, Berlin-Brandenburg has become an internationally leading location for research and development in laboratory medicine and for the implementation of clinical studies. The wide range of specialised hospitals, clinics for both basic and advanced care as well as the high-performance university medicine at the Dr. Florian Kainzinger Managing Director Labor Berlin Charité Vivantes GmbH Charité provide access to patient cohorts of the urban and rural population with some 180 different ethnic backgrounds and covering virtually all medical themes. The development of the German capital region as an internationally desired location for diagnostics development is an outstanding example for the successful implementation of the Common Innovation Strategy of the States of Berlin and Brandenburg (innobb) and a major component of the HealthCapital cluster. Diagnostic know-how for outstanding development and patient care Labor Berlin Charité Vivantes GmbH is Europe s largest clinical laboratory, providing optimal conditions for driving the development of innovative diagnostics in cooperation with leading companies like BioMérieux, Roche Diagnostics and Thermo Fisher Scientific. Labor Berlin is participating in the development of a fully integrated automation solution in microbiology and has introduced a platform for next-generation sequencing (NGS) into routine analysis. Since April 2013, the clinical laboratory has been standardising its operations in a single location at the Charité Campus Vir- With our new central location, we have established the foundation for intensive interdisciplinary exchange between the specialist laboratories and for the integration of clinical expertise. This high expertise, methodological competence and our high routine sample volumes of more than 35 million analyses per annum for more than 400,000 hospital and some one million outpatients contribute to optimal patient care, while also forming an ideal basis for the development of improved IVD technologies. 18

19 BioTOP-Report Diagnostics chow-klinikum. More than 10,000 hospital beds in and around Berlin will be provided with high-performance diagnostics from this new location. Efficient technology transfer based on regional networks BioResponse and DiagnostikNet BB have emerged as company-driven networks whose intensive cooperation with science has resulted in innovative product developments like the AK- LIDES system, which have become international market leaders. The Centre for Molecular Diagnostics and Bioanalysis (ZMDB) has driven regional and international cooperation between science and industry as a successful platform for know-how and technology transfer since Through the ZMDB, Berlin-Brandenburg has maintained close links with nine leading European diagnostics regions since 2010 as part of the European Diagnostics Cluster Alliance (EDCA), offering regional SMEs specific market access support services. The Technology Forum In vitro-diagnostics and Bioanalysis organised by the ZMDB has been held in the capital region for the past five years and is proving to be an excellent platform for initiating sustainable dialogue between fundamental research and industrial as well as clinical application. The 5th Technology Forum in June 2013 focused on mass spectrometry, protein arrays and aptamer-based biosensors. A specially designed partnering event for diagnostics companies and research institutes permitted meeting new cooperation partners from Europe and was aimed at fostering and encouraging potential growth opportunities. Achieve innovation, shape the future Start shot for young technology companies High Tech Gruenderfonds is your partner for Seed Stage investing. We help out young, high potential startups in the early phases of technology and product development, as well as successful launching. Our assistance is not limited to our cash investments, instead we strive to add long term added-value to portfolio companies through our extensive network of professional and our accredited coaches. High-Tech Gründerfonds Management GmbH Software Internet & Telecommunication Media & E-commerce Life Science Material Science Nanotechnology & Chemistry Energy Automation Photonics Industrial Software Schlegelstraße Bonn Phone: +49 (0) Fax: +49 (0) [email protected] http: // INVESTORS OF HIGH-TECH GRUENDERFONDS II 19

20 BioTOP-Report Dr. Notghi Contract Research GmbH Full service CRO Dr. Notghi Contract Research GmbH is a high quality service provider for large, medium and small-sized companies in the pharmaceutical, generics and biotechnology industries. Our full-service offerings include Statistics, Clinical Monitoring, Medical Writing, Data Management, Study Management, Pharmacovigilance, Regulatory Affairs, IT Solutions, & Training Solutions. For 14 years, our clients have benefited from our broad expertise in clinical research to meet their business challenges. We have successfully supported and advised hundred of companies in the conduct and management of national and international projects, enabling them to bring their reliable and successful products to market in ever shorter periods of time. Founded by Dr. Arman Notghi, the company has its headquarters in Berlin as well as an office in Istanbul, Turkey. Dr. Notghi Contract Research GmbH has enjoyed continuous and stable growth thanks to the confidence placed in us by our longstanding customers and the dedication of our employees. With over 90 specialized employees available across Europe for our clients, we can rapidly and efficiently respond to a wide range of requirements. The Dr. Notghi Academy, located in Berlin, qualifies drug safety officers, clinical research associates and data managers, offers specialist workshops and global learning & development solutions for the Pharmaceutical industry. Address Dr. Notghi Contract Research GmbH Zimmerstraße Berlin Contact Melanie Wurzel Deputy CEO Phone Fax [email protected] Benefit from our Competence PAREXEL International PAREXEL International is a leading global bio/pharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting and medical communications services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, PAREXEL has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Perceptive Informatics, Inc., a subsidiary of PAREXEL, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process. Headquartered near Boston, Massachusetts, PAREXEL operates in 78 locations throughout 52 countries around the world, and has approximately 14,400 employees. PAREXEL has a long-standing presence in Berlin, where over 1,500 employees are located. Clients can benefit from state-ofthe-art technologies and equipment provided through PAREXEL s medical imaging lab and Early Phase Units, which provide a safe, high-quality environment for early phase development activities in a hospital setting. The PAREXEL Academy located in Berlin qualifies clinical research associates and clinical data managers, and offers a course for a Bachelor of Science degree in Clinical Research, validated by a British university. Address PAREXEL International GmbH Klinikum Westend Haus 18 Spandauer Damm Berlin Germany Contact Dr. Ulf Schneider Corporate Senior Vice President and Chief Administrative Officer Phone Fax [email protected] 20

21 Tradition and Innovation based in Berlin Research is carried out here Our research focuses on: analytical chemistry, pharmaceutical development and clinical research. Our findings lead to innovative and proven quality compounds. In this way, we improve quality of life for many people. Here we produce... The main focus of our product portfolio is medication for pain and diabetes therapy as well as for the treatment of disease relating to the cardiac and circulatory system or the thyroid gland. Patients have placed their trust in our medicines for over 100 years. From here we apply our know how on the market... Especially in the eastern European markets; there we have over 31 representative offices. We supply patients worldwide within the Italian Menarini Group network. BERLIN-CHEMIE, a company in the Menarini Group, stands for tradition and innovation from Berlin. For more information: BERLIN-CHEMIE AG Glienicker Weg Berlin Phone:

22 BioTOP-Report Industrial Biotechnology Focus: Biopolymers and Bio-based Plastics Bioplastics are still niche products today, but that is due to change soon. The reason: Bioplastics offer enormous potential for business and the environment. They are expected to find application in many industries soon, be it as biodegradable mulch foil for agriculture, green packaging for food, or light-construction components for cars. Germany is investing increasingly in the development of biopolymers and bioplastics, for example as part of its national research strategy BioÖkonomie The term bioplastics designates three types of materials: biobased plastics, i.e. plastics produced on the basis of biomass, petroleum-based biologically degradable plastics and those which are both, i.e. bio-based and biologically degradable. Biopolymers are the precursor of bio-based plastics. Biopolymers either occur naturally (like cellulose, starch, lignin and proteins) or they are biotechnologically manufactured polymers (like bacterial cellulose) or polymers whose synthesis components are made of renewable raw materials (like sugar or vegetable oils). Alongside the bio-based versions of classical polymers produced on the basis of petroleum (like PE, PP or PA) the so-called dropin solutions there are now new polymers like PLA or PHA. Biopolymer market set to grow in the coming years Market analyses predict an exciting future for the use of biopolymers with above-average growth. According to the Nova Institute, production capacity worldwide is to reach 12 million tons by 2020, tripling the volume of A great variety of materials and products is expected. The number of manufacturers, processing companies and, above all, users is set to rise strongly during the coming years. Materials made of biopolymers will be used in a wide range of application areas: in the packaging industry, the life sciences, in architecture and the design industry, in agriculture and forestry or in light construction for example in the transport industry. One great advantage of the biopolymers is that they are based on renewable resources and therefore reduce petroleum consumption. In addition, some biopolymers and bio-based plastics (e.g. PLA) have special characteristics which cannot be achieved with petroleum-based polymers, or only at considerable expense. Since the production of biopolymers and bio-based plastics is to grow strongly in the next few years, we can expect that rising production volumes and increased market penetration will reduce the presently still existing disadvantages in terms of both cost and optimised processing methods. High potentials for cross-innovations Plastics are everywhere and everyday life is no longer conceivable without them. Items of daily use like pens, USB sticks, mobile phone covers, breadboxes, toys or citrus presses many products are already on the market in bio-based versions. Innovative products are also being developed which use the specificity of biopolymers, e.g. more environment-friendly disinfestation systems for forestry, protein foils for bio-diapers, components for facade casings or packaging foils made of stale bread. When developing new system solutions, it is essential to involve both the raw material supplier and end user from the start to create Dr. Karl Heinz Tebel Chairman of the managing board of BASF Schwarzheide GmbH Cluster spokesman for plastics and chemistry of the state of Brandenburg As cluster spokesman for plastics and chemistry of the state of Brandenburg, I am pleased that the establishment of the Innovationszentrum Bioplastics Lausitz succeeded in close cooperation of Fraunhofer Institute for Applied Polymer Research with Kunststoffverbund Berlin/Brandenburg (KuVBB) and BASF, and innovative approaches to dealing with this interesting group of products are investigated at the newly launched Fraunhofer- Competence Centre for Bioplastics Processing at the BASF site in Schwarzheide. I am certain that such projects and initiatives pave the way for additional businesses to settle in Brandenburg. 22

23 BioTOP-Report Industrial Biotechnology comprehensive and interdisciplinary concepts for sustainable products. Innovation centre in the Lausitz In Berlin-Brandenburg, attention focuses increasingly on the topic of biopolymers. The Innovationszentrum Bioplastics Lausitz (innovation centre) in southern Brandenburg is emerging as a growth driver for biopolymers, in particular as regards their processing. The logistic advantages of the BASF location and the expertise of the Competence Centre for Bioplastics Processing which was set up in April 2013 as a branch of the Fraunhofer Institute for Applied Polymer Research (IAP) in Schwarzheide create an optimal environment for the location of more biopolymer manufacturing and processing companies in the region. From material selection, through process technology, to product development the region supports the plastics processing industry in the introduction of biopolymers and bio-based plastics. As an important source of inspiration for the innovation centre, the innovation forum Biopolymers and Bio-based Plastics was organised by BioTOP Berlin-Brandenburg, Kunststoffverbund Berlin Brandenburg e.v., BASF Schwarzheide GmbH and the Fraunhofer IAP in late 2012/early Some 200 experts from the region and beyond met in three thematic workshops and a closing conference. The opportunities and challenges in the use of biopolymers and bio-based plastics were discussed intensely and new concepts for knowledge-based development of the Lausitz as a centre for bio-based plastics were presented. More information is available at: Fraunhofer IBMT Branch Potsdam The Potsdam branch of the Fraunhofer Institute for Biomedical Engineering IBMT focuses on the development of highly innovative solutions based on modern biotechnology. The range of research activities and services is characterised by extensive expertise in the fields of cellular biotechnology, nanobiotechnology, meta-biobanking, functional surfaces, molecular bioanalytics, lab automation, cell-free protein synthesis and extremophile research on cryophilic snow algae. A major focus is currently placed on the development of systems and technologies for medical in vitro-diagnostics (ivd). Both highly motivated scientists from different disciplines and excellently trained engineers pool their expertise at the IBMT and, together with state-of-the-art-equipment, provide the basis for understanding the partner s needs and successful projects. We would be glad to be your reliable partner in research and development - don t hesitate to contact us! Address Fraunhofer Institute for Biomedical Engineering IBMT Branch Potsdam Am Mühlenberg Potsdam-Golm Germany Phone Fax Contact Prof. Dr. Frank F. Bier [email protected] 23

24 Biopeople Denmark s Innovation Network for Health & Life Sciences Innovation across disciplines To stimulate innovation we create meeting places that bring researchers and industry stakeholders together across disciplines, sectors and public-private boundaries. Our aim is to benefit global health and welfare by providing a framework that helps academia and industry to meet, co-create and develop ideas into new projects, products and services. Among our core services are matchmaking and knowledge sharing activities, as well as facilitation and brokerage of innovation projects. To stimulate innovation we create meeting places that bring researchers and industry stakeholders together across disciplines Denmark s Innovation Network for Health & Life Sciences Biopeople embraces and gathers the vast majority of public and private research within health and life science in Denmark. The network includes all relevant Danish universities, research institutions and hospitals plus the Danish Health and Medicines Authority. On the private side, industry associations contribute their resources, and we have numerous pharma, medtech, food and biotech companies as members of Biopeople. Collaboration across boarders Biopeople is part of the Danish infrastructure for innovation established and cofunded by the Ministry of Science, Innovation and Higher Education. We have an International outreach that helps Danish companies and researchers to establish cross border collaborations and vice versa. We also welcome German companies within life science to join the network. For more information please contact Science Liaison Officer Elias Zafirakos, MSc CE, EBA [email protected] Universitetsparken Copenhagen O DENMARK Or visit us at

25 BioTOP-Report Global Business New Markets and Horizons for Global Business The Bioregion Berlin-Brandenburg promoted the theme of internationalisation in 2012 with a wide range of activities and events. The Dialog Forum on Life Sciences in Brussels, the first European Technology Forum on in vitro-diagnostics, joint events with the French, British and Canadian embassies and a major survey on the international activities and strategies of regional companies underscore the importance of internationalisation in the healthcare industries cluster HealthCapital. The Region Presents Itself in Excellent Shape in Brussels In May 2012, the so far largest and most international Dialog Forum with the European Commission was held in the state representation offices of Berlin and Brandenburg in Brussels. Representatives of science and industry from Berlin-Brandenburg presented their latest projects and innovations to an audience of more than 100 in a plenary and three workshops. They also received feedback from Commission representatives on funding options in the HEALTH segment of the EU Seventh Framework Programme for Research and gained important insights into the new focus of European research funding under Horizon The evening reception provided an ideal platform for networking and exchange about future project ideas among all participants and, above all, with representatives from seven other European regions. In addition, information about the funding options for non-health related biotechnology research and development was obtained in the joint workshop on Knowledge Based Bioeconomy with the German National Life Sciences Contact Unit in September The First IVD Conference and European Corporate Partnering in Berlin In June 2012, experts in the fields of in-vitro diagnostics and bioanalytics met for the 4th Berlin-Brandenburg Technology Forum at Charité - Universitätsmedizin Berlin. The event focussed on personalised medicine and next generation sequencing. Foreign companies had also been invited for the first time to meet partners in this field at the event. Some 170 participants from 11 countries came to the Charité to hear lectures by experts from science and industry. About 46% of the audience represented companies, while 13% of all participants came from abroad. A partnering session for companies and research facilities was therefore organised in parallel with the conference in cooperation with the Enterprise Europe Network. In addition, 20 companies and institutions from 11 countries exhibited their products, services and technologies in an industry show. The largest and most international Technology Forum to date also featured an extensive accompanying programme comprising an early evening reception, guided tours of prestigious research institutes and a sightseeing programme. Partner of Choice for Embassies The German-French Expert Workshop organised jointly with the French Embassy took place in November Some 136 registered participants attended talks on Systems Biology: From Modelling to Therapy of Complex Diseases. The aim of the event was to present the current state of research, the funding programmes currently available as well as projects in the field of systems biol- 25

26 BioTOP-Report Global Business Dr. Tohru Noji Head of Global Corporate Advisory Europe Industry Research Division at Mizuho Corporate Bank Ltd. London/UK Having performed a detailed cluster analysis of several European clusters, we perceive the Biotech Cluster of the German Capital Region as one of the leading in terms of business facilitation efforts and support. It offers the best conditions for becoming a fertile breeding ground for collaborations between Japan s industry and European biotech partners. ogy and to provide experts from both countries with a platform for intensive exchange and discussion of possible cooperative ventures. In the context of a joint presentation of the regions Ontario and Québec in August 2012, many representatives from the region were able to familiarise themselves with the focus areas of research and production in the field of cardiovascular diseases in Canada and meet experts from there in the Canadian Embassy. In return, a delegation of Canadian entrepreneurs attended this year s Berlin-Brandenburg Technology Forum on In-vitro Diagnostics on 5-6 June 2013, thereby extending the international dimension of the previously European event to overseas (see page 19). Innovative projects of scientists and companies from Britain and Berlin-Brandenburg in the fields of nano- and regenerative medicine were already presented in June 2012 in the British Embassy. In addition, BioTOP made a major contribution to the programme design of the successful delegation tour on the occasion of the state visit of the Grand Duke of Luxembourg in Berlin. Focus on New Markets: South America and Japan The BRIC states (Brazil, Russia, India and China) are markets of the future with huge populations, high growth and partly vast investments in their technology and research infrastructures. In Berlin-Brandenburg, too, biotech companies are setting their sights on these countries and potential BRIC cooperation partners. In 2012, BioTOP participated in two delegation tours arranged by the German Ministry of Education and Research (BMBF) to South America to prepare the ground for future cooperation projects. BioTOP was an active participant in German-Columbian government discussions in Bogotá in June as an expert for the development of cluster structures in the life sciences sector, and in August 2012 we presented a talk on the BioRegion Berlin-Brandenburg and, in particular, the region s bioeconomics activities during an exploratory visit to Brazil sponsored by the BMBF and devoted to the theme of bioeceonomics. As a follow-up, representatives from the BioRegion took part in the German Brazilian Partnering Event on the Way to a BioInnovation Hub on 26 and 27 November 2012 in Sao Paulo and submitted several project applications for the tender invitation Bioeconomy International. Japan was another target country for international networking in2012. For many years, the Japanese pharmaceutical industry was mainly interested in cooperation with US biotech companies, but Europe is gradually gaining in importance as a partnering region. This made it all the more pleasing to see that Industry Research Division of the Japanese megabank Mizuho Corporate described the Bioregion Berlin-Brandenburg as one of Europe s leading regions for biotechnology in its report Life Sciences and Biotechnology Industry Clusters in Europe which was published in February Customised Services and Support based on Needs Biotechnology is shaped by global research and marketing cooperation, so that companies are exposed to international competition from the start. Biotech companies in Berlin-Brandenburg understand that and regard the expansion and consolidation of their international activities as a key component of their business operations. Nonetheless, entry into European and overseas markets is often difficult and raises a range of uncertainties especially for small and mid-sized companies (SME). To take proper account of the needs of the players in the Health- Capital cluster Berlin-Brandenburg in its future internationalisation strategy, BioTOP conducted a major survey of SMEs, hospitals and institutes in the life sciences sector in The survey also included app. 70 biotech companies in the region which were interviewed about their international business activities, existing forms of cooperation with foreign partners, their future target markets and their need for support as regards funding or presentations at fairs and exhibitions. The preliminary evaluation has already shown: Not even the smallest company can afford to ignore the theme of internationalisation today and pursue a purely regional or national business strategy. Supporting companies in their internationalisation efforts must be the aim of all our activities. 26

27 PDA Europe: The European Headquarters of the Parenteral Drug Association in Berlin The international non-profit organization PDA is the leading global provider of science, technology and regulatory information and education for the pharmaceutical and biopharmaceutical community. With more than 10,000 members who are active in the development, manufacture, quality control and registration of medicinal products worldwide, our aim is to develop scientifically sound, practical technical information and resources to advance science and regulation for the pharmaceutical and biopharmaceutical industry as well as regulatory bodies. PDA s events include conferences, meetings, and workshops held worldwide, where manufacturers, suppliers and scientists of the industry and governmental bodies meet to discuss major issues of mutual interest. This exchange of technical knowledge and expertise assist the advancement of pharmaceutical science and technology in the interest of public health. PDA develops technical information, e.g. Technical Reports ( comments on drafts of authority guidelines, organises events like congresses, workshops, Interest Group Meetings and training courses. Become a member, join committees and events, and take advantage of the exchange in expertise among experts from the entire world. Our members belong to the global players of the pharmaceutical industry, biotechnology companies, start-ups, suppliers, and authorities. Topics include everything which is important to the manufacture and quality control of pharmaceutical products. Some of the multifarious activities include process validation, monitoring, development of freeze drying cycles, GMP concept for gene-therapy products, virus deactivation and visual inspection of products. Find more information about all upcoming events on our website under europe.pda.org or under for your mobile devices. Upcoming Events September Workshop, Exhibition, Training Courses 6 th Workshop on Monoclonal Antibodies Basel September Conference, Exhibition, Training Courses Pharmaceutical Freeze Drying Technology Düsseldorf 8-11 October Conference, Exhibition, Training Courses Pharmaceutical Cold Chain Integrity Berlin 4-8 November Workshop, Conference, Exhibition, Training Courses The Universe of Pre-filled Syringes and Injection Devices Basel February Conference, Exhibition Microbiology Endotoxins RMM Berlin March Conference, Exhibition Parenteral Packaging Brussels For general information please contact: PDA Europe, Adalbertstr Glienicke / Berlin, Germany Tel: +49 (0) Fax: +49 (0) [email protected] For exhibition information please contact: Elke von Laufenberg Exhibition & Sponsorship Manager PDA Europe Tel: + 49 (0) [email protected] europe.pda.org Anzeige_VBKI.indd :49

28 BioTOP-Report Business Location Excellent Services for Berlin-Brandenburg Due to its high concentration of science and research establishments, the Berlin-Brandenburg region offers outstanding potential for technological development and cooperation. The joint Life Sciences Team from the Berlin Partner business development agency and the Brandenburg Economic Development Board ZAB supports the life sciences industry with a full range of services, including marketing activities at national and international exhibitions. Berlin-Brandenburg stands out in the life sciences because every segment of the health industry is present here. The high concentration of international excellence facilitates interdisciplinary exchange and makes it easier to achieve new landmark developments. At the same time, the sheer number of players can make it difficult to find the right partner. Our staff and colleagues at BioTOP have been in direct contact with the region s companies and scientific institutions for many years and can provide quick access to the right contacts and potential partners. In 2012, the Berlin Partner Life Sciences Team supported expansion projects and provided location services to 22 companies in the capital region, which will create around 500 new jobs in the next three years. One of them is Takeda Pharma Vertriebs GmbH & Co. KG. Since autumn 2012, Takeda has been directing all its marketing and sales activities for the German market from Berlin with some 100 employees. In addition, service functions for Austria and Switzerland are also centralised in Berlin. And one of the company s two production sites in Germany also located in the capital city region: The plant in Oranienburg is a state-of-theart production facility for tablets, caplets and capsules with more than 500 employees. particular mention. The joint acquisition team with Berlin Partner arranged the location of Analytica Alimentaria GmbH in Kleinmachnow, while a further direct investment supported by the team concerns the company plusblut GmbH in Hennigsdorf. In 2012, the region was represented with its own booths at four important international fairs. The aim was to position the region s companies on the global markets and present the cluster of the healthcare industries in Berlin-Brandenburg HealthCapital as one of Europe s leading health sector locations. Berlin Partner also organised an information booth at BIO 2012 in Boston and BIO 2013 in Chicago. As in the years before, the Berlin-Brandenburg Night was held on the opening day of BIO. Bayer Healthcare acted as the lead sponsor once again. Both events attracted some 400 international guests from biotechnology and pharmaceutical companies, which followed the invitation from HealthCapital and Bayer HealthCare. Carolin Clement Head of Unit Biotech I Pharma Berlin Partner for Business and Technology Phone: [email protected] In the field of the life sciences, ZAB supported almost 70 investment and innovation projects in Brandenburg, which created app. 150 new jobs. The successful location of technology-based start-ups like OakLabs GmbH and t-cell Europe GmbH deserves Dr. Ute Hartmann Head of Department Healthcare Industry/Life Sciences Brandenburg Economic Development Board (ZAB) Phone: [email protected] 28

29 Life Sciences. Living Research. Berlin. Brandenburg. A vibrant network Berlin-Brandenburg is one of Europe s leading locations for the Life Sciences. It is also an R&D capital that magnetically attracts the world s top scientists. Here you ll find attractive subsidy conditions, close linkages between business and science, the highest concentration of R&D in Europe, a dynamic startup scene and a multifaceted entrepreneurial environment made up of more than 500 pharmaceutical, biotech and medical engineering companies. Come discover this one-of-a-kind landscape for scientists and entrepreneurs.

30 BioTOP-Report Technology Transfer Technology Transfer between Science and Business Project concepts in the life sciences are usually very complex. It may sometimes take decades until ideas and insights from basic research can be made available for commercial use. Many initiatives now exist which aim to accelerate that process and render the usually non-linear development processes more systematic. This applies to the research location Berlin-Brandenburg in particular. The capital region s unique research and university landscape possesses an enormous potential in terms of knowledge and ideas, which can be converted into new product developments. The German federal government and the states have recognised the need for technology transfer instruments and programmes. A number of programmes to support patent commercialisation, university spin-offs and cooperation between research facilities and companies have already been implemented. Vouchers for Transfer Close cooperation between science and industry is a key precondition for successful transfer of technological knowledge from academic research into companies. Cooperative ventures between SMEs and research facilities are supported by the TransferBO- NUS programme in Berlin and the Innovation Voucher initiative in Brandenburg. They reduce the financial costs incurred by companies which award research assignments and ease their Dr. Rolf Strittmatter Managing Director ZukunftsAgentur Brandenburg GmbH With its innovation vouchers, the State of Brandenburg is helping small and mid-sized companies establish and extend contacts with universities and other academic institutions by supporting small research and development projects. The aim of this successful programme is to create stronger ties between business and science, overcome barriers and foster innovations based on cooperation. More than 300 innovation vouchers were assigned since They enable companies in Brandenburg to buy research expertise and obtain support funding of up to More than 30 of the initiatives supported to date were health sector projects on themes ranging from software development for health applications, design solutions for patient care and new telemedical applications. They all document the increasing interconnection between the health economy and adjacent sectors. access to the latest insights in science and research. These two funding programmes thereby help improve the participating companies innovation capacity and competitiveness and hence secure a successful future for them. Up to 70 % of the contract volume of research services can be supported in this way, with a maximum of 15,000 Euros. Both programmes have been taken up very well: In the health economy sector, twelve TransferBonus projects were funded in 2012, while Brandenburg help launched six projects with its Innovation Vouchers. i2m: Ideas to Market Projects in science usually aim to generate research results. Their developments therefore often end at a point where it is hard to convince investors and licensees that they can be translated into a product. Scientists find it difficult to assess the commercial value of their ideas, and what is usually lacking is also the proof of concept, in other words: the validation of their idea. This is the initial point of action of the project i2m ( ideas to market ) sponsored by the states of Berlin and Brandenburg. i2m aims to transfer promising projects more quickly from the academic sphere to commercial application and thereby close the gap between publicly funded academic basic research and industrial development. The initiative specifically addresses scientists in basic research and project developers who had few opportunities for commercialisation to date. For every project, the aim is to jointly develop the proof that efficient implementation is feasible. Impfzervix at the Charité is one of the projects supported. It aims to achieve accelerated development of a therapeutic vaccine for gentle treatment of cervical cancer. i2m supported the project launch and funding application and thereby helped procure 1.5 million Euros in support funding. More than 30 projects were supported 30

31 BioTOP-Report Technology Transfer Financing and Added Value Venture Capital for companies in Berlin successfully to date, and it has become clear that i2m can trigger a cascade of development steps in many projects helping to bring the respective product to market. Entrepreneurial Network University In the life sciences, Freie Universität (FU) Berlin and Charité Universitätsmedizin Berlin benefit from the nationwide competition EXIST University-Based Business Start-Ups. For their concept of an Entrepreneurial Network University (ENU) they received 2.8 million Euros from the German Federal Ministry of Economics and Technology. The two institutions can now implement the concept with support funding until They have cooperated in founder promotion since This cooperation is now to move to a new dimension under the umbrella of the ENU and to be extended to additional partners. Special attention will be devoted to the consolidation of IT-technologies with applications in the health sector into the joint focus health-it, as the interface between the life sciences and IT is gaining increasing importance to the development of innovative medical processes and products. IBB Beteiligungsgesellschaft mbh offers equity financing for high tech companies in Berlin. For our fund VC Fonds Technologie Berlin ( 52m) we are looking for investment opportunities in the biotechnology and medical technology sector. Our investment approach is based on hands-on involvement and active management support for each portfolio company, delivered by our highly experienced investment team. VC Fonds Technologie Berlin not only provides capital, but also helps execute the business plan. Are you interested? Please do not hesitate to contact us. Prof. Dr. Peter-André Alt President of Freie Universität Berlin (FU) With our Entrepreneurial Network University, we want to promote networking between science and industry and the founder spirit among young people. The joint founding activities of Freie Universität Berlin and the Charité will concentrate on the health economy as a focus area. Here, we can benefit from existing networks, sector initiatives and events, from the companies already located here, from outstanding extramural research facilities and from the initiatives of the cluster management unit HealthCapital. And we also want to contribute our own initiatives. One example: in the United States, private incubators like Health Box and Rock Health already utilize the increasing founder potential on the interface between IT and the health sector. The ENU will be the first German university to establish a pre-incubator for this business field. IBB Beteiligungsgesellschaft mbh Mrs. Ute Mercker / Mr. Christian Seegers Bundesallee Berlin / Germany Phone: +49 (0) Selected portfolio companies: VC Fonds Technologie Berlin was set up as a joint initiative of Investitionsbank Berlin (IBB) and the State of Berlin. It is co-financed by the European Regional Development Fund (ERDF). 31

32 BioTOP-Report Technology Transfer CoLaborator: An incubator space for start-ups Alongside many publicly funded initiatives, Bayer HealthCare announced its concept for a second CoLaborator after San Francisco at its Berlin location in May The new CoLaborator of Bayer HealthCare will be established in direct vicinity to the company s own research laboratories and provide suitable premises for rent for up to ten bioscience start-ups whose ideas, developments and technology platforms match Bayer s own research activities. Internal research at Bayer HealthCare focuses on four core therapeutic fields: oncology, cardiology, gynaecology and haematology. The project will support the young entrepreneurs in establishing their research labs and, if desired, act as their first contact for cooperation with industry. The CoLaborator has a building of its own with an area of app. 800 sqm, of which some 420 sqm are laboratories. Prof. Dr. Andreas Busch Member of the Executive Committee of Bayer HealthCare and Head of Global Drug Discovery Cooperation with academic partners and biotech companies is a key element of Bayer HealthCare s innovation strategy. We strongly believe that jointly using the enormous knowledge inside and outside the company will help us to get a better understanding of major disease mechanisms and to improve drug development. The new CoLaborator in Berlin will foster communication and cooperation with innovative partners in Berlin. Berlin/Bremen/Cologne/Frankfurt/Hamburg/Munich/Stuttgart Life sciences companies are in safe hands with UHY. UHY Deutschland AG is a joint venture of long established auditing and consulting firms with a total of 250 employees and partners. UHY Deutschland AG has extensive experience in financial and consulting services for life sciences companies for many years. We offer the following services: As a member of UHY International, a global association of independent accounting and consulting firms with over 7,000 employees we can provide audit, accounting, tax and consulting services in 270 business centres across the globe. ppaudits of financial and consolidated statements under the German Commercial Code (HGB) and IFRS ppaccounting & Reporting ppdue diligence (financial and tax) and business valuations ppconsulting services on IPOs ppbusiness Advisory ppmergers & Acquisitions (M&A) ppgerman and international taxation 32 Contact Dr. Ulla Peters UHY Deutschland AG Wirtschaftsprüfungsgesellschaft/Zimmerstraße 23/D Berlin Phone /Fax /

33 Life Sciences from A to Z Excellence, Diversity and Critical Mass in the Capital Region What are the main projects of the region s researchers? What are their answers to important future challenges in the life sciences? Stay informed, download BioTOPics45 at:

34 BioTOP-Report Life Sciences A Science and Research Hub Nationally and internationally, Berlin-Brandenburg is regarded as one of the leading life sciences hubs. The region offers optimal conditions for this field as a TOP life sciences location with five universities, many higher education facilities and a unique extramural research density. Its most prestigious institutions in biotechnology and the life sciences include four Max Planck Institutes, four Leibniz Institutes, two Fraunhofer Institutes and two centres of the Helmholtz Association. In addition, the region is home to a wide range of hospitals, headed by one of the largest university hospitals in Europe, Charité Universitätsmedizin Berlin. From pharmaceutical research, through diagnostics, theranostics and molecular genetics, to the development of innovative biomaterials for medical application, scientists from diverse disciplines, including medicine, biology, chemistry, nutrition science, bioinformatics, pharmacology and physics, cooperate closely in the German capital region. In addition to scientific expertise, Berlin-Brandenburg also offers an excellent infrastructure with its wide range of networks and transfer platforms which link universities, research facilities and users. A new dimension in the transfer of insights from basic into clinical research is now provided by the Berlin Institute of Health (BIH) which was opened in June 2013 and will further enhance the position of the capital region as a leading centre for translational and systems medicine. You will find more information in this topic on page 36. Ideas for biobased products of the future Biotechnology know-how is finding areas of application with considerable potential beyond the healthcare sector. The development and production of biomass-based plastics will be in increasing demand in the future and also offers major opportunities for the innovation capacity and economic potential of Berlin-Brandenburg. Of special importance to this field are the Leibniz In- APRIL 2012 The Berlin scientist Tatiana Krotkova of Leibniz-Institut für Molekulare Pharmakologie (FMP) and of NeuroCure cluster of excellence at Charité-Universitätsmedizin Berlin receives this year's research award for young scientists from Human Frontier Science Programs (HFSP) ++++ MDC-researcher Prof. Michael Gotthardt and Prof. Norbert Hübner discover a new mechanism for myocardial disease in collaboration with colleagues from the USA ++++ A Euro research award of the Deutsche Rheumaliga is awarded to the Deutsches Rheuma-Forschungszentrum Berlin (DRFZ) MAY 2012 Max-Delbrück-Centrum receives multi-million euro funding for a German- Israeli doctoral training programme ++++ A common matter of the heart for 140 top scientists: German Centre for Cardiovascular Research ++++ At the Institute for Biomaterial Science of Helmholtz-Zentrum Geesthacht in Teltow, a new Helmholtz graduate school for macromolecular bioscience is being set up ++++ Transatlantic Consortium for Regenerative Medicine founded in Berlin ++++ Charité Universitätsmedizin Berlin reaches rank 1 of Focus-ranking "Germany's best hospital" JUNE 2012 Charité Universitätsmedizin Berlin attracts another graduate school in the Excellence Initiative: Berlin School of Integrative Oncology ++++ John-Hopkins-University and Fraunhofer Heinrich Hertz Institute sign agreement in principle to jointly develop medical applications of integrated optical sensors JULY years in 100 seconds: The Berlin scientist Leif Schröder at the FMP has breakthrough with his group in new diagnosis method ++++ Neuronal stem cells destroy brain tumours MDC and Charité-scientists elucidate new mechanism of action AUGUST 2012 MDC-scientists Dr. Sandrine Sander and Prof. Klaus Rajewsky of MDC Berlin- Buch discover new key element in formation of Burkitt lymphoma ++++ Gertrud Reemtsma Foundation awards HU-biophysicist Peter Hegemann as cofounder of optogenetics with the Zülch-Preis 2012 SEPTEMBER 2012 Scientists of Charité Universitätsmedizin Berlin and Labor Berlin succeed in deciphering the molecular signature of Hantavirus infection in humans ++++ Graduate school BSRT receives support from the Friede Springer Foundation OCTOBER 2012 A team of scientists around Anna Flögel of German Institute of Human Nutrition (DifE) and Tobias Pischon of Max-Delbrück-Centrum (MDC) identified 14 new biomarkers for type-ii diabetes which can be the foundation of the development of new ways of therapy and prevention for the metabolic disease The World Health Summit brings top-class participants to Berlin for the fourth time. 34

35 BioTOP-Report Life Sciences stitute for Agricultural Engineering (ATB) in Potsdam-Bornim whose research focuses on resource-efficient and carbon-neutral use of biological systems for the production of foods, raw materials and energy, and the Fraunhofer Institute for Applied Polymer Research (IAP) in Potsdam-Golm, which is a leading provider in the field of applied cellulose and starch research and opened a competence centre for biopolymer processing at the BASF site Schwarzheide in April 2013 (see on page 23). As part of a nationwide programme of the German Federal Ministry of Education and Research (BMBF), new concepts for future biotechnology have been developed jointly with research organisations and universities since 2010 to provide the foundation for the development of a bio-based economy. To see which projects in Berlin-Brandenburg are involved in this programme, please turn to page 41. Certified excellence In addition to Freie Universität Berlin, the Humboldt Universität zu Berlin also succeeded with its concept for future development in the context of the Excellence Initiative for cutting-edge research at institutions of higher education. One of the university s main goals thus is the continued development of its Integrative Research Institute (IRI) for the Life Sciences (see on page 36). Other life sciences projects and initiatives in Berlin-Brandenburg funded under the Excellence Initiative include the Berlin-Brandenburg School for Regenerative Therapies BSRT (a graduate school in the field of Regenerative Medicine), NeuroCure (a Cluster of Excellence focused on the neurosciences) and UniCat (the Cluster of Excellence Unifying Concepts in Catalysis ). You will find more detailed information on these Excellence Initiatives and an overview of other research projects involving scientists from Berlin and Brandenburg in our publication BioTOPics 45 Life Sciences from A to Z. NOVEMBER 2012 Federal and state governments agree to found the Berlin Institute of Health (BIH). It is created from the merging of Charité and Max Delbrück Center for Molecular Medicine. In the future, scientists conducting basic research and clinical research will thus work hand in hand. DECEMBER 2012 Christian Hackenberger receives Leibniz Humboldt professorship for chemical biology ++++ Performance of German Institute of Human Nutrition (DifE) rated as very good to excellent ++++ MDC celebrates 20th anniversary. JANUARY 2013 Charité and FU are jointly successful in the competition "EXIST-Gründungskultur Die Gründerhochschule" of the German Federal Ministry of Economics and Technology ++++ German Research Foundation extends collaborative research centre (SBF 650) at Charité ten million Euros for research on immunological therapy FEBRUARY 2013 Humboldt research award gets Ivy-League professor Klaas van Wijk to Potsdam ++++ Biopolymers strong future field with high potential for innovation presents itself in Schorfheide MARCH 2013 Hasso-Plattner-Institut speeds up personalised medicine with new data bank technology ++++ Integrative Research Institute for Life Sciences (IRI) founded in Berlin ++++ Paul Ehrlich- and Ludwig Darmstaedter Prize goes to MDC scientist Dr. James Poulet APRIL 2013 Charité and Sorbonne found Virchow-Villermé Centre for Public Health ++++ EU-OPENSCREEN included in the new BMBF-roadmap for large research infrastructures MAY 2013 New laboratory building of MDC opened named after physiologist Max Rubner ++++ Stem cell researchers in Germany pool their expertise. They found the German Stem Cell Network (GSCN) on May 7 th Evaluators praise Berlin Institute of Health (BIH). Enst Theodor Rietschel becomes chairman JUN 13 BIH officially opened ++++ Charité Universitätsmedizin Berlin once more reaches rank 1 of Focus-ranking "Germany's best hospital" 35

36 BioTOP-Report Life Sciences Know-how in Systems Medicine and Systems Biology In the past years, it has become evident that determining the function of singular genes is insufficient for understanding the processes in our body and the development of diseases. Therefore, biomedical research increasingly follows a holistic approach. The new key words in this context are systems biology and systems medicine. Researchers use highly modern techniques to gain precise insight into the molecular networks of genes and their products, the proteins, as well as their regulation and interaction, to understand their importance in the development of diseases. The resulting vast quantity of data is evaluated with help of mathematics, informatics, and powerful computers. In the German capital region, significant know-how has been built and structures have been created for this. Amongst the internationally prominent names of Berlin medicine in this context are the Max Delbrück Center for Molecular Medicine (MDC) it focuses on basic research and is part of the Helmholtz Association and in clinical research the Charité - Universitätsmedizin Berlin. MDC and Charité now combine their research in the newly founded Berlin Institute of Health (BIH). It will be set up with public funds of 300 million Euros until Additionally, 40 million Euros come from the benefactor Johanna Quandt. The BIH follows a holistic, systems medical approach for the first time in Germany. That means steering away from single organs or disease patterns towards the overarching mechanisms causing diseases. In doing so, systems medicine uses genetic, cell biological, biochemical, and physiological methods, imaging techniques, and extensive technology platforms. The aim is the medical translation, meaning the development of new diagnostic techniques, therapies, and preventive measures to increase and speed up the transfer of research findings to hospitals. Humboldt Universität (HU) is also invested in interdisciplinary life sciences research. The Integrative Research Institute (IRI) for Life Sciences, funded by the Excellence Initiative of federal and state governments, is a core project of the university s plans for the future, having gained the status of elite university in The scientific areas involved in the project range cover the entirety of life, from the molecular level to the complex organism. The research focus of the IRI lies on the areas of commitment of the Prof. Ernst Rietschel CEO Berlin Institute of Health BIH With the establishment of the Berlin Institute of Health (BIH), the German federal government and the federal state of Berlin want to respond to proposals from the academic sector to promote translational research, i.e. the transfer of research results into clinical practice and back. In the new institute, the MDC and Charité will combine their basic and clinical research. In this endeavour, systems medicine plays an essential conceptual role representing a unique selling point of the BIH. institutions supporting it: Systems biology and theoretical biology (represented by centres of HU, Charité, and MDC); Neurosciences (represented by the Bernstein Center Berlin, an excellence cluster and a graduate school of HU) as well as infection biology and immunology (represented by the Center for Infection Biology and Immunity of HU). From these areas of focus, the IRI wants to strengthen the connection between theoretical and experimental techniques as well as clinical application areas. The everyday life in hospitals is set to profit especially from research insights into neurological diseases (nervous system, strokes), oncological diseases, and regenerative medicine. An important part of the IRI will be the Berlin Institute for Medical Systems Biology (BIMSB) of the MDC, which is a pioneer of systems biology in Germany. Founded 2008, it focuses on the research of post-transcriptional regulation of the genome and its influence on cancer, cardiac, metabolic, and neurologic diseases. 36

37 The Bilateral Workshop Perspectives of Systems Biology Systems biology was also the theme of the annual bilateral workshop in the French Embassy in Berlin. On 23 November 2012, German and French scientists reported to some 100 workshop participants on the current status of systems biology research in their countries. Opportunities for closer cooperation were also explored. The participants included: Prof. Nikolaus Rajewsky, Scientific Director of the Berlin Institute for Medical Systems Biology (BIMSB) who wants to investigate with his team how the expression of genes can be controlled after they have been read, e.g. using micrornas. Photo: BBB Management GmbH / David Ausserhofer Cancer research remains the key field in systems biology. This was also confirmed by a contribution from France: The research team under Dr. Emannuel Barillot at the Institut Curie in Paris aims to develop data generated by high throughput methods into an interaction map in order to observe cancer formation and tumour growth at the molecular level. Bringing together genetic sequences, proteome analyses and the results from the analysis of tissue samples is to provide the starting point for new approaches in the struggle against cancer. Dr. Karin Effertz from the German Federal Ministry of Education and Research (BMBF) reported on the new BMBF funding programme e:med Measures for the Establishment of System Medicine. During the next eight years, the ministry will support research in systems medicine with some 200 million Euros. Special importance is placed on the active participation in big international projects and to cross-border cooperation. Dr. Stéphane Roy, Attaché for Science and Technology, French Embassy Dr. andreas eckert founds and finances biotechnology and medical technology companies For one hundred years, physicians and researchers in Buch have been working together towards the common value of health. Dr. Andreas Eckert is one of the few venture capital providers in Germany who have specialized in bioscience companies. He has already contributed to the successful founding of several biotechnology and medical technology companies on Campus Berlin-Buch. Get acquainted with Buch, its partners and the unique campus atmosphere where the future of medicine is being created. EuropEan union European regional Development Fund

38 BioTOP-Report Bioparks Networks Scientific Institutions P Companies Biotech Networks kkbiotop Berlin-Brandenburg kkbiohytec Network for Biohybrid Technologies kkbioresponse kkcenter for Molecular Diagnostics and Bioanalytics (ZMDB) kkdiagnostiknet-bb kkgabi Genome Analysis in the Plant Biological System kknetddd Network for Drug Discovery & Development Berlin-Brandenburg kknetwork Glycobiotechology Berlin-Brandenburg kknutrigenomics Network Berlin-Brandenburg kkregenerative Medicines Initiative Berlin-Brandenburg kkrina Network for RNA Technologies Scientific Institutions kkberlin-brandenburg Center for Regenerative Therapies (BCRT) kkbrandenburg University of Technology (BTU) kkcharité Universitätsmedizin Berlin kkfraunhofer Institute for Applied Polymer Research (IAP) kkfraunhofer Institute for Biomedical Engineering (IBMT) kkfreie Universität Berlin (FU) kkgerman Heart Instiute Berlin (DHZB) kkgerman Institute of Human Nutrition (DIfE) kkgerman Rheumatism Research Center (DRFZ) kkhumboldt-universität zu Berlin (HU) kkinstitute of Biomaterial Sciences, Helmholtz-Zentrum Geesthacht (Teltow) kklausitz University of Applied Sciences kkleibniz-institute for Agricultural Engineering Potsdam-Bornim (ATB) kkleibniz-institut für Molekulare Pharmakologie (FMP) kkleibniz-zentrum für Agrarlandschaftsforschung (ZALF) e. V. kkmax Delbrück Center for Molecular Medicine (MDC) Berlin-Buch kkmax-planck-institute for Colloids and Interfaces kkmax Planck Institute for Infection Biology kkmax Planck Institute for Molecular Genetics kkmax Planck Institute of Molecular Plant Physiology kkrobert Koch Institute kktechnische Universität Berlin (TU) kkuniversity of Applied Sciences Berlin (HTW) kkuniversity of Applied Sciences Wildau kkuniversity of Potsdam 38

39 BioTOP-Report IFHI 39

40 BioTOP-Report Life Sciences COSMOS Coordination of Standards in Metabolomics Metabolomics is applied not only in human medicine as a diagnostic tool but also in plant science. Is a tumour malignant? Will a plant produce a large amount of biomass? These and other questions can potentially be answered with metabolic profiles. Metabolic profiles permit assessing the current status and further development of cells or tissues. The use of this technique was promoted primarily at the Max Planck Institute of Plant Physiology (MPI-MP) in Potsdam-Golm. Prof. Lothar Willmitzer, one of the directors at the institute, is regarded as a pioneer in this field, and Dr. Joachim Kopka and his team created one of the first important databases for metabolomics data, the Golm Metabolome Database (GMD). To facilitate data exchange at the European level, the COSMOS initiative was launched. COS- MOS short for Coordination of Standards in Metabolomics is managed by the European Bioinformatics Institute (EBI) and aims to create a database in which researchers from all disciplines can store data in standardised formats together with information about the design of their experiment. In this way, the metabolomics researchers at the MPI-MP will play a key role in organising the integration of existing data resources. In addition to collecting the actual measurement data, the description of the experiments performed is also a major challenge. The retrievability and comparability of studies is improved by standardised vocabulary and computerised data entry. It is impossible to predict traits of the full-grown plants just by looking at the seedlings, which look all too much alike. Metabolic profiles are a lot more revealing and give information about the future phenotype and composition of the plants. (Source: MPI-MP) 40

41 BioTOP-Report Life Sciences Life Sciences Biotech With its funding programme Base Technologies for Next Generation Biotechnology Processes, the German Federal Ministry of Education and Research (BMBF) wants to create the foundation for a bio-based economy and promote the German production location. The research concepts receiving funding are working on the development of entirely new biotechnological production processes. Under the first funding stage of the programme, 35 research projects have taken up work on base technologies for next generation biotechnological processes. They are investigating the full range of possible new methods in biotechnology and are supported with 42 million Euros by the BMBF. The projects are interdisciplinary, involving experts from the life sciences and engineering as well as chemistry, physics and medicine. The four leading German research organisations also played a major role in defining the strategy process Biotechnology from the start. The topics range from a modular bioreactor for cell-free protein synthesis (Fraunhofer Society) through synthetic biology (Max Planck Society) and printable biotechnology (Helmholtz Association) to new synthesis methods by which natural materials can be manufactured for medicine (Leibniz Association). In the German capital region, the Fraunhofer Institute for Biomedical Engineering (IBMT) is coordinating the national joint research project Biomolecules from the Production Line at its branch in Potsdam, while the Max Planck Institute of Colloids and Interfaces in Potsdam is participating in the Max Planck Research Network MaxSynBio, which will take up work in early Other projects in the German capital region participating in the programme are: kk BioPICK Modularised multi-phase biocatalysis by enzymatically active w/o Pickering emulsions in a membrane reactor Prof. Anja Drews Hochschule für Technik und Wirtschaft, Berlin Prof. Marion Ansorge-Schumacher Technische Universität Dresden k k Use of solar energy for bioelectrocatalysis: development of photobioelectrode structures for synthesis Prof. Fred Lisdat Technische Hochschule Wildau Dr. Heiko Lokstein, Prof. Athina Zouni Technische Universität Berlin k k Synthetic biosystems from the cell to fabrication (Cell2Fab) Dr. Katrin Messerschmidt, Prof. Bernd Müller-Röber Universität Potsdam 41

42 BioTOP-Report Alacris Theranostics GmbH Alacris Theranostics GmbH, operative since September 2011, is specialised in developing new approaches in personalised medicine for cancer patient diagnosis, treatment and drug stratification. Alacris has built up a next-generation sequencing laboratory for the analysis of clinical samples and applies a systems biology approach for patient and drug stratification using the ModCell TM software which is exclusively licensed to Alacris. This approach has been originally developed in the department of Prof. Lehrach at the Max Planck Institute for Molecular Genetics. Based on genome and transcriptome information and including kinetic pathway information, mutation and drug databases it is providing a Virtual Patient model. This Virtual Patient can predict the effects of drug treatment and optimised combinatory treatment for personalised medicine approaches. ModCell TM also facilitates biomarker discovery and "Virtual Clinical Trials" for patient and drug stratification. kkproviding more rapid approval of drugs in targeted non-randomised trials kkrepositioning of drugs or recovery of "fallen angels" for the pharmaceutical industry kkcomplex biomarker discovery kkreducing animal testing via virtual trials Address Alacris Theranostics GmbH Fabeckstraße Berlin Germany [email protected] Unlocking The Power Of Individualised Medicine Alacris' work provides the opportunity for: kkfinding targeted personalised treatment for the patient kksaving negative side effects kkreducing health costs for non-necessary treatment kkoptimising stratification of drug treatment Analytisches Zentrum Biopharm GmbH Berlin Analytisches Zentrum Biopharm GmbH Berlin is a testing facility for pharmaceutical analytics. Tests are carried out on pharmaceutical products and raw materials (stability tests, batch tests, method development and validation). The laboratories have all the equipment needed for these tests according to ICH and pharmacopoeias. Climatic chambers are available for storing samples under ICH conditions. Narcotics, hormones and cytostatic agents are handled on a daily basis. The portfolio also includes determining the content of active ingredients in biological matrix (e.g. plasma samples from clinical studies on humans or availability studies on agricultural livestock, tissue samples from withdrawal period studies on farm animals and others). High-performance LC-MS/MS devices for high sample throughput are available for this. The analytical studies are performed according to the applicable European and FDA guidances. The testing facility uses quality assurance systems according to GLP and GMP that have been successfully certified by the authorities. The GLP certificate includes test categories 1 and 8, so that physical-chemical tests are also carried out according to REACH. The GMP certificate covers the quality control/batch check on finished medicinal products and pharmaceutical raw materials. Further information is available from Address Analytisches Zentrum Biopharm GmbH Berlin Bitterfelder Strasse Berlin Germany Contact Dr. Ulrich Kunter [email protected] Phone Phone

43 BioTOP-Report BIOTECON Diagnostics GmbH BIOTECON Diagnostics was founded in 1998 and is established as a well-known qualified global partner for the food and beverage industry as well as for producers of pharmaceuticals and cosmetics. BIOTECON Diagnostics focuses on development, production and marketing of rapid detection systems for pathogens, allergens, animal species, genetically modified plants and beverage spoilage organisms in food, feed and other matrices like environmental samples. The foodproof, foodproof SL and microproof Detection and Quantification Kits, based on real-time PCR, are developed as easy-to-use systems to provide fast, safe and specific results for manufacturers and consumers. Now AOAC and MicroVal validated, BIOTECON Diagnostics has offered automated sample preparation and test setup solutions since The foodproof RoboPrep + Series, a fully automated system for the analysis of pathogens, was the first system on the market especially designed for the needs of the food industry. The foodproof RoboPrep Flex offers a convenient and robust solution for the automated extraction and purification of plant DNA from food and feed samples. BIOTECON Diagnostics additionally offers customized contract development and production. Due to close contacts with many different industries, the company is well aware of customers current and future challenges. BIOTECON Diagnostics is thus able to provide flexible solutions to production and processing companies through new, tailored, and economical approaches. Address BIOTECON Diagnostics GmbH Hermannswerder Potsdam Germany Contact Kornelia Berghof-Jäger, Ph. D. CEO Alois Schneiderbauer CBO Phone Fax [email protected] BioTeZ Berlin-Buch GmbH BioTeZ is focused on biotechnological products and services for life science research, pharmaceutical industry and diagnostics. In many business fields BioTeZ has own technologies with outstanding properties, e.g., in the sphere of immunoaffinity columns, HRPlabeling, sundry streptavidin coatings and the development of enzyme immunoassays. On the basis of many years' experience the powerful diagnostic tool recoveryelisa was created for monitoring therapies with biologics. Business fields at a glance: Immunoaffinity chromatography kkproduction of customized IAC kkcoupling of different ligands, e.g. antibodies against mycotoxins Premium oligonucleotid synthesis kkdna / RNA incl. modifications Streptavidin coating kkmicroplates and other surfaces and materials kkpolystrept R for high binding capacity, excellent for lateral flow assays Contact BioTeZ Berlin-Buch GmbH Robert-Rössle-Straße Berlin Germany Phone Fax [email protected] ELISA development and services kkinclusive conjugate development, labeling, purification etc. Companion Diagnostics kkrecoveryelisa a new diagnostic method to predict and to measure interaction between therapeutic antibodies or biologics and their target molecules. 43

44 BioTOP-Report co.don AG co.don AG is a public biopharmaceutical company, founded in November 1993, since 2001 listed on Frankfurt stock exchange. co.don AG manufactures cell-based tissue engineering therapeutics of the highest purity and to the highest quality standards. Its products represent a revolutionary process in the biological replacement of damaged articular cartilage and invertebral disc by building up strictly autologous tissue without the involvement of any external carrier materials or additives. The application of the products may be minimally invasive or arthroscopic and so surgery and rehabilitation times significantly reduced for doctor and patient. Because no external materials are used, the risks of rejection, inflammation and infection are very slight. co.don AG is certified in accordance with DIN EN ISO 9001:2008. Furthermore, production, quality control and quality assurance have been certified in accordance with European Guidelines for Good Manufacturing Practice (EU-GMP) since In 1997 co.don AG was the first biopharmaceutical company in Europe to be granted a permit for the manufacture of autologous chondrocyte and osteoblast transplants under section 13 of the German Drugs Law (AMG). co.don AG s technological, production and regulatory expertise makes the company a first mover in the market for biological cartilage disc tissue replacement and a provider of highly effective, safe treatment options between pain therapy and endoprothetics. Address co.don AG Warthestraße Teltow Germany Contact Matthias Meißner, M.A. Head Corporate Communications/IR/PR Phone Fax [email protected] Epigenomics AG Epigenomics is a molecular diagnostics company developing and commercializing a pipeline of proprietary products for cancer diagnosis. The Company s products enable doctors to diagnose cancer earlier and more accurately, leading to improved outcomes for patients. Epigenomics lead product, Epi procolon 2.0, is a second generation bloodbased test for the early detection of colorectal cancer, which is currently marketed in Europe and has been submitted to the FDA for US regulatory approval. With clinical studies indicating a majority of colorectal cancers are detected with the test added to the convenience of a simple blood draw, Epi procolon is expected to improve compliance for colorectal cancer screening and save lives through early detection of disease. Laboratory test services based on this technology are available in the U.S.A. and Canada by our partnering laboratories Quest, ARUP, Companion Dx and Gamma Dynacare. Epigenomics product portfolio further includes Epi prolung, a confirmatory test aiding in the diagnosis of lung cancer that is marketed in Europe, and additional products in development for colorectal, lung and prostate cancer. The Company s technology and products have been validated through multiple partnerships with leading global diagnostic companies. Epigenomics is an international company with operations in Berlin, Germany, and the U.S.A. For further information please visit Address Epigenomics AG Kleine Praesidentenstraße Berlin Germany Phone Fax [email protected] 44

45 BioTOP-Report Evestra GmbH Evestra GmbH, founded in July 2008, is a fully owned subsidiary of Evestra Inc. located in San Antonio Texas. Evestra GmbH serves as the development and commercialization center for Europe and ROW. Evestra s mission is to develop and commercialize steroid-based female healthcare products. The development strategy of the company includes product ideas with known compounds as well as New Chemical Entities. Evestra is conducting research and product development in a number of in-demand, but as yet unmet, medical need areas of women s health such as hormonal-dependent breast cancer and endometriosis. The company is also pursuing different projects in fertility control, e.g. a new estrogen for oral contraception, with superior pharmacological properties compared to the standard drug ethinyl estradiol. Address Evestra GmbH Britzer Straße Berlin Germany EU Contact Prof. Klaus Nickisch Managing Director Phone [email protected] Several patents on new composition of matter, new technical processes and use patents have been filed during the last years and support the strong intellectually property position. Evestra is concentrating on R&D and will seek more partners for commercialization. More detailed information can be found on our website. LGC Genomics LGC Genomics ( is the genomics division of the international science-based LGC Group. LGC Genomics merged 2011 with KBioscience, a UK-based technology company providing its own range of SNP genotyping chemistry and novel instrumentation to the life science research and quality control communities. Now we provide a full range of high quality genomics products, services and solutions including sample preparation, nucleic acid extraction, DNA sequencing, genotyping and biobanking. LGC Genomics operates from three laboratory centers in Germany, USA and United Kingdom. The portfolio includes: kkgenotyping services, assays and reagents kksanger and NextGen sequencing services on Roche 454 & Illumina HiSeq and MiSeq platforms kkdna and RNA extraction products and services kkdna / RNA biobanking kkstorage kkretrieval and analysis services kkreagents and consumables for molecular biology kklaboratory instrumentation kkplate sealers kkliquid handling robots kkhigh-throughput PCR thermal cyclers kkplate readers Address LGC Genomics GmbH Ostendstrasse 25 TGS Haus Berlin Germany Phone [email protected] LGC Limited, All rights reserved. 45

46 BioTOP-Report MOLOGEN AG MOLOGEN AG is an innovative biotechnology company with focus on cancer immuno therapies. Our drug candidates utilize various therapeutic approaches to fight severe cancer diseases. Our lead product is MGN1703 a safe and well tolerated DNA immuno modulator. It has shown high efficacy in a double-blind, placebo-controlled phase II trial in metastatic colorectal cancer and is ready to enter phase III. The immune activation is mediated through binding at the Toll-like receptor 9 in certain immune cells. The strong and broad activation enables the patients immune system to overcome the tolerance against the cancer disease. Due to this mode of action MGN1703 can be used to treat several solid cancer diseases. Next target will be lung cancer. Second lead product is MGN1601, our cell-based cancer vaccine. Through the use of living human renal cancer cells we present a full set of tumor-associated antigens (TAA) to the immune system with the aim to induce a strong adaptive immune response against these TAAs. MGN1601 underwent successfully a phase I/II trial in metastatic renal cancer. Our research for you for innovative medicines that are highly effective and well tolerated. Contact MOLOGEN AG Fabeckstraße Berlin Germany Phone Fax [email protected] Our attractive product pipeline also comprises DNA vaccines and further cancer immuno therapies. The drug candidates are based on our proprietary platform technologies. We are open for partnering and collaborations. Predemtec GmbH Predemtec GmbH is focussed on research, development, manufacture and marketing of novel Immunoassay PredemtecDX to assess dementia and dementia related risk factors before first symptoms appear. Predemtec has developed a reliable blood test for early and reliable diagnosis of various dementia-related disorders by analyzing a cluster of specific biomarkers. Controlled clinical tests indicate high specifity and reliability of our PredemtecDX. Prophylaxis and therapeutic interventions will be more efficient, when administered as early as possible, ideally before clinical symptoms show. PredemtecDX will enable a major progress in this field. Predemtec GmbH cooperates with the Institute of Immunology at the Kiel University and various geriatric institutions in Germany and Switzerland. As a member of the diagnostic network, Predemtec offers services for early dementia diagnosis to laboratories, hospitals and clinics. Address Predemtec GmbH Neuendorfstrasse 20a/c Hennigsdorf Contact Dr. Annegret Feuerhelm-Heidl Geschäftsführerin Telefon Mobil [email protected] 46

47 BioTOP-Report ProBioGen AG ProBioGen AG is an internationally operating Contract Development & Manufacturing Organization (CDMO) and Technology Provider, focused on animal cell line engineering and process development including GMP manufacturing of biopharmaceutical drug substances (therapeutic proteins and vaccines). Almost 20 years of experience in mammalian cell culture and biopharmaceutical manufacturing make ProBioGen a competent and reliable contract partner. The comprehensive technological skills and the outstanding scientific excellence, reflected in a strong intellectual property base, qualify ProBioGen to manage even the most challenging development and manufacturing projects. The pharmaceutical cell line development program is based on proprietary expression vector technology, optimized clone selection and screening workflow complemented by an in-house chemically defined cell culture media platform. Two preselected CHO host cell lines (DG44- and K1-strains for optimal product quality) fit perfectly into the rapid upscale processes and achieve excellent product yields and stability. Comprehensive analytical methods development and validation goes hand in hand with state-of-the-art GMP manufacturing programs. All services and technologies are embedded in a total quality management system to assure compliance with international ISO and GMP standards (EMA/FDA). An experienced project management ensures that projects are completed strictly in time and on budget. Besides the state-of-the-art services, ProBio- Gen develops innovative technologies, such as: kkglymaxx This fucose-targeted glyco-engineering technology increases the binding of antibodies to NK cells and thus enhances ADCC. As a permanent modification it can be rapidly applied to any existing antibody producer cell lines or to entire expression platforms. kkpathway Modulator Technology This permanent cell modification increases productivity even for difficult to express proteins. It is applicable to new and pre-existing producer cell lines. kkage1 Designer Cell Lines The AGE1 cell line family was created by defined immortalization of primary cells for different purposes. kkthe AGE1.CR cell line originates from the Muscovy Duck and was established to replace primary chicken cells in vaccine production. The cell line allows GMP-complaint production of a wide spectrum of vaccines and viral vectors. kkthe AGE1.HN human neuronal cell line supports complex specific glycostructures (highly sialylated, highly branched). It is used for glycoproteins which require manufacturing in human cells. kkhuman Artificial Lymph Node (hualn) The hualn is a fully human minibioreactor system to assay drug-related effects on the immune system in vitro. This unique 3-D matrix-based technology uses primary lymphocytes to emulate in vivo conditions of the human immune system and allows long-term analyses of immunogenicity, immunofunction and immunotoxicity. Founded in 1994, ProBioGen is located in Berlin, Germany, and enjoys a global customer portfolio ranging from small biotech firms to large pharmaceutical companies. Address ProBioGen AG Goethestraße Berlin Germany Contact Dr. Gabriele Schneider VP Business Development Phone Fax [email protected] 47

48 BioTOP-Report syneed medidata GmbH Are you getting the whole picture? We Do. syneed medidata GmbH is an independent, privately owned contract research organization (CRO) that has been providing end-toend services for phase I to phase IV clinical trials and for observational studies for more than 25 years. Since 1995, we have also excelled in trials with medical devices, and in trials involving medical imaging, including all responsibilities of an Imaging Core Lab (ICL). With our exceptionally low staff turnover, project teams usually remain stable, even throughout multi-year projects, and as such facilitate project delivery in time and highest quality. syneed medidata GmbH combines experience with the quality, dedication and flexibility of a midsized organization. Our proprietary EDC system, tailor-made for multinational observational studies, gets enthusiastic feedback from both customers and end-users. Its advantages are, among others, unlimited flexibility in study design and multilingualism, compatibility with ipad and Android tablets, and an attractive price/ performance ratio. So, for almost any trial you can think of, we provide the expertise you need for turning data into results. Full-service for clinical trials Proprietary EDC system Very high staff retention Tailor-made services instead of one-size-fits-all approaches High experience of staff High quality delivered while being reasonably priced Address syneed medidata GmbH Cicerostraße Berlin Germany Phone [email protected] Contact Dr. Achim Zinggrebe CEO Medical Director Imaging [email protected] syneed imaging syneed imaging, the Medical Imaging Core Lab of syneed medidata GmbH, offers solutions for study planning, protocol development, site evaluation, image collection and processing and conduct of central independent reviews with a wide variety of criteria (i.e. RECIST, 1.0 and 1.1, Choi, Cheson, irrc, RANO, PERCIST, mrecist). Since 1995, we have managed trials involving medical imaging (oncology, neurology, radiology, devices) and conducted central reads in our offices in Constance and Berlin as well as remotely. Our experience, flexibility and pricing especially for early phase trials are highly valued by Biotech clients. All study data are hosted solely in Germany on our servers maintained by own IT staff. Address syneed imaging & syneed medidata GmbH Cicerostraße Berlin Germany Phone Contact Isabel Kloer MD Medical Director Imaging [email protected] 48

49 Expertise in Life Sciences Special English Industrial Biotechnology 2013 (Vol. 4) Publication date: February 25 th, 2013 Supplement Healthcare 2013 (Vol. 7) Publication date: March 30 th, 2013 VentureCapital Supplement Personalized Medicine 2013 (Vol. 3) Publication date: May 31 th, 2013 Special edition Biotechnology 2013 (Vol. 15) Publication date: September 14 th, 2013 Advertising close: September 2 th, 2013 Supplement Medical Technology 2013 (Vol. 11) Publication date: October 26 th, 2013 Advertising close: October 14 th, 2013 Contact media sales team Katharina Meindl Tel. +49 (0) [email protected] Tel. +49 (0) Karin Hofelich Tel. +49 (0) [email protected] Tel. +49 (0) Only GoingPublic Magazin s Special Industrial Biotechnology is published in English, all others in German. Further info:

50 BioTOP-Report Biotech Parks The BioCampus Network Berlin-Brandenburg Berlin-Brandenburg boasts seven biotechnology parks, which offer optimal space for the specific requirements of every company. This geographic concentration of specific biotech parks is unique in Germany and probably in all of Europe. The parks differ in their offers and strategic focus and provide ideal conditions for newcomers. More than half of the 222 companies are currently utilizing the infrastructure of a publicly or privately managed park. In addition, the young companies benefit from the closeness to science and the permanent contact and exchange. berlinbiotechpark In the very heart of Berlin berlinbiotechpark Management GmbH Herr Frank Elsner Max-Dohrn-Straße Berlin Phone Fax [email protected] berlinbiotechpark is located on a 86,000 sq.m. site in the very heart of Berlin, currently offering a total of approx. 63,000 sq.m. of office, laboratory and production space, with a building potential for another 45,000 sq.m. of rental area. The site, which is home to Biotech/Pharma/Service Companies is supplied with a complete range of media for laboratory and production purposes, with production steam with possibility to upgrade to HP steam, power supply, compressed-air, nitrogen and other inert gases, cooling water and DI-water, all being provided at favorables rates. The infrastructure includes conference facilities as well as works security and waste disposal services. It is rounded off by production-related services such as plant engineers and laboratory technicians, industrial safety engineers, a medical service as well as best-buy services and communication services. Offering flexible growth potential, production-orientated media equipment and comprehensive industrial-specific services and infrastructure, berlinbiotechpark is particularly attractive for growing internationally orientated technology companies. Furthermore, it offers a permanent base in Berlin for developing companies that have outgrown the size allowed by their limited start-up funding. The inner-city location and the excellent public transport guarantee short ways to all scientific institutions and hospitals of the city. Biotech Campus Potsdam Research on the Waterfront Biotech Campus Potsdam Steinstraße Potsdam Phone Fax [email protected] Contact: Gabriele Ziegler Just a few minutes away from Potsdam s central railway station in the direction of Caputh, Biotech Campus Potsdam is located on the Hermannswerder peninsula in the river Havel. It is owned and operated by Biotech Campus Potsdam GmbH, a fully owned subsidiary of the Investment Bank of the State of Brandenburg. 50

51 BioTOP-Report Biotech Parks The biotechnology center is housed in four buildings dating from around 1900 and one modern complex and offers a total of 11,400 sq.m. of laboratory, office, greenhouse and storage space. With such a large facility at its disposal, it offers biotechnology companies an ideal environment for successful operations. All labs are approved as S1 laboratories and meet the building requirements for approval as S2 labs. The Hermannswerder site also includes an S3 laboratory as a special resource. The beautiful, park-like setting of the peninsula offers an excellent environment for research activities. The island hotel and a conference center are located directly next to the campus. The site also includes a self-service restaurant and small island shop. The philosophy of Biotech Campus Potsdam was, and still is, to create the freedom for research and innovation in the hightech sector of biotechnology. Reputable firms from the industry can indeed be found here. Biotechnology Park Luckenwalde Space for Expansion Biotechnologiepark Luckenwalde c/o SWFG mbh Im Biotechnologiepark, TGZ I Luckenwalde Phone Fax [email protected] Contact: Dipl.-Ing. Christoph Weber Director Located just 25 miles from the new Berlin-Brandenburg International Airport (BBI) in the district of Teltow-Flaeming, the Biotechnology Park Luckenwalde is one of the most modern facilities of its kind in Germany. It is home to 35 companies from Germany, USA, UK, Korea, Israel and Russia with about 550 employees. The work carried out by resident companies is multi-faceted, ranging from green biotechnology, the development of vaccines, the development of pharmacologically active substances based on plant materials, the development and production of PCR tests for food testing and preclinical contract research right through to medical technology. A total of 200 employees work on the site. Companies in the park focus on the development and production of pharmaceuticals, recombinant proteins and diagnostic kits, biological/chemical substances for biotech and pharmaceutical applications, as well as fine chemicals. There are also suppliers of medical technology, analytical services, and a Biotech Education Center. Technical Equipment comprises completely furnished S2 laboratories (safety workbench, autoclave, dishwasher, deionized water, water purification system, central media supply (compressed air, N 2, Co 2, O 2, H 2 ), storage and cool rooms, pharmaceutical clean rooms category (B/C), 400 MHz NMR spectrometer, 51

52 BioTOP-Report Biotech Parks meeting rooms, conference hall (300 seats), library, restaurant with catering service. The entire central technique meets GMP/ISO 9001 specifications. The park management offers comprehensive, individual services and advice during the settlement and development of firms, including support for the implementation of quality management systems and GMP certification. Currently the park offers sq.m. labs and office space, and additional sq.m. industrial property ready for expansion. Co:bios Technologiezentrum Service for all stages of growth and expansion co:bios Technologiezentrum GmbH Neuendorfstraße 20 a Hennigsdorf Phone Fax [email protected] Located in the northwest of Berlin, the co:bios Technology Center in Hennigsdorf is the congested urban area in Berlin-Brandenburg of biotechnology and life science. In the last 15 years more than 30 companies with approximately 700 international employees have settled on this site. On more than sq.m. we offer service space for extension to clean rooms (class D/E/F), S1 labs, DI-water supply, compressed air supply, special gas supply, state of the art data communication, meeting rooms, conference hall and more. The building and central technique requirements also meet the fulfillments for S2 labs for GMP/ISO 9001 based production specifications. As a center of excellence for biotechnology and life science we have a selected portfolio of service and advice to young start-ups as well as medium sized companies, in aim to support them across all stages of company growth. For those companies who have outgrown their limited start-up funding, we additionally hold sq.m. developed industrial property ready for expansion. With our holistic approach combining settlement, development, construction and licensing issues to the point of traditional management consulting, and on the background of the high density of innovative, research-intensive and service-oriented companies on the co:bios biotechnology park Hennigsdorf we can initiate interesting synergy effects for your business model. Within this locational advantages the co:bios biotechnology park became a magnet for the international healthcare industry and the percentage of international settlements on this site is growing, fore example from USA, South America, VAI and Asia. Campus Berlin-Buch Interaction of Research, Clinics and Companies Robert-Rössle-Straße Berlin Phone Fax [email protected] Contact: Dr. Andreas Mätzold Executive Manager Dr. Ulrich Scheller Executive Manager Berlin-Buch is the location of one of the largest biotechnology parks in Germany, with square meters of scalable lab and office space for start-ups and maturing companies. Situated to the northeast of the city, the Berlin-Buch Campus is currently home to 56 companies, 40 of which are biotech companies; the rest provides support services. 52

53 BioTOP-Report Biotech Parks Beside the BiotechPark the Max Delbrück Center for Molecular Medicine, the Leibniz Institute for Molecular Pharmacology as well as clinical groups from the Charité University Hospital within the Experimental and Clinical Research Center are part of the Campus community. The Campus gives access to high-end technology platforms, state of the art infrastructure, interdisciplinary communication, projects and expertise in a wide range of items, especially in translational research. The BiotechPark at the Campus Berlin-Buch offers: kk Immediately available lab and office space kk Excellent research and clinical expertise on-site kktraining programs for personnel on spot kkan international community of like-minded people kk Interdisciplinary networks and platforms Berlin Adlershof Germany s leading Science- and Technology Park Adlershof Zentren für Biotechnologie und Umwelt WISTA-MANAGEMENT GMBH Rudower Chaussee Berlin Phone Fax [email protected] Contact: Heidrun Terytze Head of Center for Biotechnology and Environment The BiotechPark including the Innovation and Incubation Center is managed by BBB Management GmbH Campus Berlin-Buch. Acting as a full-service company BBB s main tasks are the settlement, accompanying and support of Biotech businesses. Berlin Adlershof focuses on photonics and optical technologies, material and microsystems technology, information and media technology, as well as biological, environmental and energy technology. There are currently 25 biotech companies in Adlershof occupying 18,200 sq.m. of lab and office space. The environmental, biological and energy technology companies focus on: kkanalytics: Tracing substances in foodstuffs and groundwater, cosmetics, waste; Quality assurance, Identification of pollutants kkbiotechnology: Research development and marketing or manufacture of base materials for biotechnology and chemical processes, of biochips and biochip-based biomedical procedures, of technical enzyme preparations kkenvironmental technology: Remediation work based on innovative microbiological processes for degradation of pollutants or production of specific microbial anacultures; Research in the field of supercritical media and high-pressure technology; 53

54 BioTOP-Report Biotech Parks High-sensitivity detection systems for biotechnology and genetic engineering; Laser technology kkpharmacy, Medicine and Medical Technology: Equipment engineering and measurement technology; Research for medical chemistry the capabilities and interests of all institutions, associations and companies that operate at Science Park Potsdam-Golm. Technical Equipment comprises laboratories with a basic equipment: security-lockers, laboratory basins, work benches, vacuum supply, preliminary setup for supply of pure gases and compressed air, reconfiguration for further media and gases, central cooling, preliminary setup for cold water supply in rental areas, refitting of heat exchanger by the tenant possible. Science Park Potsdam-Golm Connecting Excellence The GO:IN Innovation Center offers young technology-based companies and entrepreneurs a range of office and laboratory spaces along with extensive services and optimal support for a successful market launch. Close proximity to the other players at Potsdam-Golm and the intensive networking of the different institutions and companies here offer perfect conditions for the development and exploitation of synergies. Standortmanagement Golm GmbH Am Mühlenberg Potsdam-Golm Phone Contact: Friedrich W. Winskowski Managing Director Science Park Potsdam-Golm combines cutting-edge international research and the training of young scientists in a high-powered location in the immediate vicinity of the German capital Berlin. Alongside the Faculty of Science and the Human Sciences Faculty of the University of Potsdam, three Institutes of the Max Planck and two of the Fraunhofer Society as well as an innovation center with currently 22 companies operate in Brandenburg s largest science park. More than 2500 people work at Potsdam-Golm and more than 9000 students are pursuing their academic qualifications here. The pleasant and very family-friendly working environment on the edge of a nature conservation area, the high quality of life in and around Potsdam and continuous growth make Potsdam- Golm a highly attractive location. Professional site management is extending the park infrastructure and fosters the integration of 54

55 BioTOP-Report Addresses Networks 56 Biotech Parks 57 Other Parks 57 IP Asset Management 57 Universities and Research Centers 57 Banks and VCs 58 Supporting Organisations 58 Pharmaceutical Companies 59 Contract Manufacturers 60 Contract Research Organisations 60 Biotech Companies 61 For Companies on the Rise Equity Financing building on your strengths! Are you looking to expand your business and maximize on growth prospects in the technology sector in Germany? Yet, you require some support and equity financing to get your project successfully underway in a new marketplace? Then, we are the right partner for you! We pride ourselves in providing the best in equity financing to our 150 corporate clients totalling over 150 million in strategic financing. We are dedicated to assisting our customers to advance their businesses in new areas and to enable sustainable growth of business and even greater success. Remember, your success is our success. Let us be part of your success story! Contact us now. Foto: ILB

56 BioTOP-Report Networks BioHyTec Verein für Bioanalytik und Biohybrid-Technologien e. V. BioResponseNetzwerk DiagnostikNet-BB Netzwerk Diagnostik Berlin-Brandenburg GABI Genomanalyse im Biologischen System Pflanze Glykostrukturfabrik Health Capital Berlin-Brandenburg Network for Drug Discovery & Development (NetDDD) Netzwerk Nutrigenomik Berlin- Brandenburg Regenerative Medicine Initiative Berlin-Brandenburg RiNA -Netzwerk RNA-Technologien Zentrum für Molekulare Diagnostik und Bioanalytik BioHyTec is the biohybrid technology network in the life sciences cluster of Berlin-Brandenburg. This new field of technology is the interface between biosensor development and biohytec.de microsystems technology. Biohybrid systems open up new applications in pharmaceutical research, clinical diagnostics, food analysis and genetic engineering. BioResponse is an interdisciplinary research and development organisation with members from Brandenburg, Berlin and Saxony. It focuses on the development and marketing bioresponse.de of multiplex assays for diagnostic antibody identification based on the proprietary Bio- Response technology, which is comprised of fully automated image analysis of fluorescence-encoded microparticles and labelled cell structures. DiagnostikNet-BB is the Berlin-Brandenburg network for in vitro-diagnostics. Members diagnostiknet-bb.de include biotech companies as well research institutes and clinics. Main objectives of the network are: Development of system solutions, optimizing compatibility, close cooperation with leading clinicians and joint marketing. GABI stands for Genome Analysis of the Plant Biological System and is an associative project supported by the German Federal Ministry of Education, Research and Technology gabi.de (BMBF) as well as a number private enterprise companies. These companies are grouped under the Business Platform promoting Plant Genome Research GABI e. V. (WPG). A Patent and Licence Agency associated with GABI (GVS) has the task of commercialising and protecting research results by means of licence rights. The Network Glycobiotechnology Berlin-Brandenburg brings together scientists with many glykostrukturfabrik.de different areas of competence in studying and utilizing complex carbohydrates. The aim is product-oriented development of the region s wide range of glycobiological technologies, building a complete glycobiotechnological process chain and to establish the region as a center of competence in the field of glycobiotechnology. In order to develop the scientific and economic position of the region, the governments of healthcapital.de the states of Berlin and Brandenburg have put the master plan Healthregion Berlin Brandenburg into effect. Its key to a continued success is a continued close interplay between research, development and education7vocational training with production, application and supply. All of these activities are integrated and coordinated through the Network Gesundheitswirtschaft Berlin Brandenburg under the brand of HealthCapital. The Network for Drug Discovery & Development Berlin-Brandenburg was launched in 2007 fmp-berlin.info/technology-transfer/netddd as an open interdisciplinary initiative with the aim to accelerate the transfer of clinical relevant findings into innovative drugs and therapeutic concepts. The network was co-founded by the Leibniz-Institut für Molekulare Pharmakologie (FMP) and BioTOP Berlin-Brandenburg. Next to offering support to research groups working on early drug discovery projects the NetDDD focuses on networking activities and professional training in the field of early drug development. Nutrigenomics is a highly innovative and fast-growing interdisciplinary field of research nutrigenomik.de linking genome research, plant biotechnology and molecular nutritional research and offering new applications for medicine and nutrition. Nutrigenomics aims at providing an understanding for how nutrition affects the balance between health and disease. Network partners include local universities and research institutes, private enterprises, public-sector organizations and various collaborative project groups. The mission of the RMIB is to promote the Berlin-Brandenburg region as a center of excellence for Regenerative Medicine particularly for cell-based medical biotechnology. The rmib.de RMIB promotes networking in the field and supports the further development of clinical studies and education programs. The initiative fosters the collaboration between universities, research institutes, companies (including SMEs) and organizations in the field of science and technology. The RNA-Network provides ongoing support and funding for the development of RNA technologies with the goal to commercialize the results. One main focus is the improvement rna-network.com and application of the RNA interference technology. Further projects develop RNA aptamers, cell-free protein biosynthesis systems and analyse the structure and function of RNA molecules. The RiNA RNA-Network encourages co-operation and information exchange between academy and industry. The Centre for Molecular Diagnostics and Bioanalytics (ZMDB) is a virtual centre operated zmdb.de under the auspices of the Fraunhofer Institute for Biomedical Technology and the Charité Universitätsmedizin Berlin in close cooperation with the region s company networks. The aim is to bring together regional expertise in basic research, technology development, clinical research and industrial cooperation initiatives to set up joint projects that will speed up the development of in vitro-diagnostics Made in Berlin-Brandenburg. 56

57 BioTOP-Report Biotech Parks berlinbiotechpark Biotech Campus Potsdam Biotechnologiepark Luckenwalde Co:bios Technologiezentrum GmbH Campus Berlin-Buch bbb Management GmbH Adlershof Zentren für Biotechnologie und Umwelt berlinbiotechpark is located on a 86,000 m² site in the very heart of Berlin, currently berlinbiotechpark.de offering a total of approx. 57,000 m² of office, laboratory and production space, with a building potential for another 45,000 m² of rental area. Offering flexible growth potential, production-orientated media equipment and comprehensive industrial-specific services and infrastructure, berlinbiotechpark is particularly attractive for growing internationally orientated technology companies. Just a few minutes away from Potsdam s central railway station in the direction of Caputh, biotechcampus.de BIOTECH CAMPUS POTSDAM is located on the Hermannswerder peninsula in the river Havel. It is owned and operated by BIOTECH CAMPUS POTSDAM GmbH, a fully owned subsidiary of the Investment Bank of the State of Brandenburg. Located just 30 miles south of Berlin and 25 miles from Berlin-Brandenburg International bio-luck.de Airport in the rural district of Teltow-Flaeming, the Biotechnology Park Luckenwalde is one of the most modern facilities of its kind in Germany. It is home to 38 companies with 500 employees from Germany, USA, UK, Korea, India, Italy and Russia. The co:bios Technology Center in Hennigsdorf offers affordable rental opportunities and a cobios-technologiezentrum. selected portfolio of services and advice to young start-ups as well as medium-sized companies. Therefore Hennigsdorf is a center of excellence for life sciences, especially in the de field of red biotechnology and medical technology. Berlin-Buch is home to one of the largest biotechnology parks in Germany, with bbb-berlin.de square meters of scalable lab and office space for start-ups and maturing companies. Situated to the northeast of the city, the campus is currently home to 49 companies, 35 of which are biotech companies; the rest provide support services. Berlin Adlershof is one of the most successful high-tech locations in Germany with focus adlershof.de on Photonics and optical technologies, material and microsystems technology, information and media technology, biological, environmental and energy technology. There are currently 25 biotech companies in Adlershof occupying 18,200 sq.m of lab and office space. Other Parks Science Park Potsdam-Golm GO:IN Golm Innovationszentrum GmbH Innovationspark Wuhlheide Science Park Potsdam-Golm is one of the most innovative and promising locations in Brandenburg. In the GO:IN facility, innovative companies will find an excellent working environment where they will benefit from the synergy effects of the location and the specific equipment offered by its laboratories. The location provides a wide range of services and consulting, as well as integration into the existing regional networks. Located just 30 miles south of Berlin and 25 miles from Berlin-Brandenburg International Airport in the rural district of Teltow-Flaeming, the Biotechnology Park Luckenwalde is one of the most modern facilities of its kind in Germany. It is home to 38 companies with 500 employees from Germany, USA, UK, Korea, India, Italy and Russia. wissenschaftsparkpotsdam.de goin-potsdam.de bio-luck.de IP Asset Management Ascenion ZukunftsAgentur Brandenburg GmbH Brainshell Ascenion advises public life science research institutions, universities, hospitals, freelance inventors and companies in all aspects of intellectual property asset management. Brainshell is an independent consulting agency specializing in intellectual property services for businesses.brainshell manages and markets the patent portfolios of all colleges, universities, and research institutes in the State of Brandenburg. ascenion.de brainshell.de Universities and Research Centers BAM Federal Institute for Materials Research and Testing Berlin-Brandenburg Center for Regenerative Therapies (BCRT) BfR Federale Institute for Risk Assessment Brandenburg University of Technology Charité - Universitätsmedizin Berlin Deutsches Rheuma-Forschungszentrum Berlin Fraunhofer Institute for Applied Polymer Research (IAP) Fraunhofer Institute for Biomedical Engineering (IBMT) Freie Universität Berlin German Heart Instiute Berlin bam.de b-crt.de bfr.bund.de tu-cottbus.de charite.de drfz.de iap.fraunhofer.de ibmt.fraunhofer.de fu-berlin.de dhzb.de 57

58 BioTOP-Report Universities and Research Centers German Institute of Human Nutrition (DIfE) Humboldt-Universität zu Berlin htw Berlin University of Applied Sciences Institute of Biomaterial Sciences, Helmholtz-Zentrum Geesthacht (Teltow) Institute for the Reproduction of Farm Animals Schönow Inc. Lausitz University of Applied Sciences Leibniz-Institute for Agricultural Engineering Potsdam-Bornim (ATB) Leibniz-Institut für innovative Mikroelektronik Leibniz-Institut für Molekulare Pharmakologie (FMP) Max Delbrück Center for Molecular Medicine (MDC) Berlin-Buch Max Planck Institute for Infection Biology Max Planck Institute for Colloids and Interfaces Max Planck Institute for Molecular Genetics Max Planck Institute of Molecular Plant Physiology Robert Koch Institute (RKI) Technische Universität Berlin (TU) University of Applied Sciences Berlin University of Applied Sciences Wildau University of Potsdam dife.de hu-berlin.de htw-berlin.de hzg.de ifn-schoenow.de fh-lausitz.de atb-potsdam.de ihp-microelectronics.com fmp-berlin.de mdc-berlin.de mpiib-berlin.mpg.de mpikg.mpg.de molgen.mpg.de mpimp-golm.mpg.de rki.de tu-berlin.de beuth-hochschule.de tfh-wildau.de uni-potsdam.de Banks and VCs BC Brandenburg Capital GmbH Berliner Sparkasse-Kompetenzzentrum Gründungen und Unternehmensnachfolge Berliner Volksbank eg bmp Life Science AG Business Angels Club Berlin Commerzbank AG Creathor Venture Demeter Partners Deutsche Bank AG High-Tech Gründerfonds Management GmbH IBB Beteiligungsgesellschaft mbh Investitionsbank Berlin Investitionsbank des Landes Brandenburg KfW-Mittelstandsbank Peppermint Venture Partners GmbH Ventegis Capital AG bc-capital.de lbb.de berliner-volksbank.de bmp.com bacb.de commerzbank.com creathor.de demeter-partners.com db.com high-tech-gruenderfonds.de ibb-bet.de ibb.de ilb.de kfw-mittelstandsbank.de peppermint-vp.de ventegis-capital.de Supporting Organisations Berlin Partner für Wirtschaft und Technologie GmbH BioTOP Berlin-Brandenburg Investitionsbank Berlin (IBB) Investitionsbank des Landes Brandenburg Landesamt für Gesundheit und Soziales Berlin (LAGeSo) Support of international and domestic companies in all issues regarding locating to Berlin. berlin-partner.de BioTOP Berlin Brandenburg is the central contact and coordination office for all issues biotop.de concerning biotechnology in the German capital region. Company financing and consultation on subsidies and processing grant applications in ibb.de Berlin. Company financing and consultation on subsidies and processing grant applications in ilb.de Brandenburg. One Stop Agency for all licensing and approvals, for questions concerning biomedicine, berlin.lageso.de biotechnology and pharmaceuticals and for more general issues connected with health, disease control and public health in Berlin. 58

59 BioTOP-Report Supporting Organisations TCC Technologie Coaching Center Specific Coaching offers for innovative high tech companies. coachingbonus.de Technologie Stiftung Brandenburg TSB Technologiestiftung Berlin Gruppe ZAB Zukunftsagentur Brandenburg ZAK Zentrale Anlauf- und Koordinierungsstelle Senatsverwaltung für Wirtschaft, Arbeit und Frauen The technology Foundation Brandenburg is dedicated to the advancement of science and research, especially in the field of innovative technologies. ts-bb.de The TSB Technology Foundation Berlin Group is a public private partnership in the German tsb-berlin.de capital region to develop science and industry networks for technology transfer, joint projects, and regional innovation strategies. The Brandenburg Economic Development Board functions as a one-stop agency for all kinds of business support services. Helps you find your way through the Berlin administration. Supports complex urban development policy and investment projects. zab-brandenburg.de berlin.de/sen/wirtschaft/zak Pharmaceutical Companies Advance Pharma GmbH ALPHAMADE GmbH Bausch & Lomb Dr. Mann Pharma Bayer Pharma Aktiengesellschaft BERLIN-CHEMIE Aktiengesellschaft Chemisch-pharmazeutisches Labor, Rolf Sachse GmbH CT Arzneimittel Dr. Kade Pharmazeutische Fabrik GmbH Haupt Pharma AG Heyl chemisch pharmazeutische Fabrik GmbH & Co. KG Klosterfrau Berlin GmbH medphano Arzneimittel GmbH Contract manufacturer of solid drugs.galenic development and admissions, analytics and microbiology, coating and granulation (organic and aqueous), compacting, packaging. Customized formulations as medications: parenteral feeding, intradialytic parenteral feeding, omega-3 fatty acids, cytostatics. advance-pharma.eu Bausch & Lomb is the eye health company dedicated to perfecting vision and enhancing bausch-lomb.de life for consumers around the world. Core businesses include soft and rigid gas permeable contact lenses and lens care products, and ophthalmic surgical and pharmaceutical products. Bayer Pharma is one of the ten largest specialty pharmaceutical companies in the world and the company's goal is a leading market position in each of its specialist fields. With its distinctive expertise in research, the company develops new medicines and therapies which make an essential contribution toward improving patient's quality of life. bayerhealthcare.com BERLIN-CHEMIE is a German subsidiary of the MENARINI Group. The company, which was berlin-chemie.de formed in 1886 and is headquartered in Florence, was developed over the generations to become a global, owner-managed pharmaceutical company. Research is centred on the development of innovative drugs for the following areas: inflammatory diseases and pain, cardiovascular diseases, oncology, viral disease. CPL S: Custom synthesis development of active pharmaceutical ingredients (API s), Contract manufacture of active pharmaceutical ingredients from laboratory to kiloscale, Phar- cpl-sachse.de maceutical analysis. CT Arzneimittel is a pharmaceuticals company that focuses on generics production. Prescription medicines form the bulk of the product portfolio, which includes some 1,200 ct-arzneimittel.de drugs with more than 200 different active agents that are used to treat the most common clinical syndromes. The company s activities concentrate on the production and marketing of drugs in the kade.de fields of gynecology, proctology, pain relief/ rheumatism and urology. The potential of proven drugs is expanded systematically by galenic developments to produce innovative products. With&nbsp,nine production sites Haupt Pharma is one of the leading contract manufacturers for pharmaceutical products in&nbsp,the world&nbsp,today.&nbsp,about haupt-pharma.de 2.000&nbsp,employees produce for an established clientele of more than 200 important international pharmaceutical companies, amongst which 15 of the international TOP 25. HEYL is an independent, entrepreneurial family business that has its headquarters in probably the liveliest German metropolis, Berlin, since its establishment in In coopera- heyl-berlin.com tion with our international subsidiaries, the main focuses of our work are the Regulatory Affairs and marketing of medicines as well as the sale of active pharmaceutical ingredients (API's) and special chemicals. For more than 175 years Klosterfrau has been developing, manufacturing and marketing pharmaceutical products. The profile of traditional yet modern natural medicines has grown significantly in recent times. Based on the latest scientific discoveries combined with the development of new markets, the range is constantly being expanded with innovative products. medphano Arzneimittel in Rüdersdorf stands for proven and cost-effective pharmaceutical medphano.de preparations. Main products are analgesics/anti-rheumatics, antibiotics, dermatics, diuretics, drugs to stimulate blood circulation, drugs for treatment of gastro-intestinal disorders, vitamins, expectorants, lipid-lowering agents, ophthalmics, cosmetics, food supplements, diet foods and foods. 59

60 BioTOP-Report Pharmaceutical Companies MUCOS Pharma GmbH & Co.KG Nycomed Oranienburg GmbH As a specialist in enzyme preparations Mucos supplies a steadily growing market with mucos.de specific and variably dosed enzyme combinations. The company leads the world market in oral enzymes for therapeutic purposes. As the competence centre for the development, production and packaging of solid dosage nycomed.de formulations Nycomed Oranienburg plays an important part in the global Nycomed operations network. It supplies the global pharmaceutical markets in more than 100 countries, from Europe to the US and Japan. The products include corporate Nycomed products and contract manufacturing for third parties.&nbsp. Pfizer Pharma GmbH Pfizer is the world's largest research-based biomedical and pharmaceutical company. pfizer.de Pharma Action Pharma Action has extensive expertise in global pharmaceutical marketing and manufacturing pharma-action.com since 1988 and offers cutting edge API solutions to the pharmaceutical industry in Europe and abroad. Piramal Imaging GmbH Piramal Imaging is a start-up business within the Life-Science division of the Mumbai-based Piramal Enterprises Group. The company is dedicated to the clinical research & imaging.piramalenterprises. com development and the global commercialization of Nuclear Medicine / Molecular Imaging products for detection, characterization and monitoring of disabling and life-threatening diseases in neurology, oncology and the cardio-vascular space. Sanofi-Aventis Deutschland GmbH Sanofi-aventis is a leading global pharmaceutical company based in Paris and operating sanofi-aventis.de in over 100 countries. R&amp,D teams work on a global approach to patients, offering innovative therapeutic strategies in thrombosis, cardiovascular diseases, diabetes, vaccines, oncology, the central nervous system disorders and internal medicine. Shire Deutschland GmbH Shire s strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit and hyperactivity disorder, human genetic therapies and gastrointestinal diseases. Spreewälder Arzneimittel GmbH Spreewälder Arzneimittel is a contract manufacturer of drugs, veterinary drugs, food supplements, diet foods and cosmetics in liquid, semi-solid and solid administration forms. spreewaelder-arzneimittel.de Steiner & Co. Deutsche Arzneimittelgesellschaft mbh & Co. KG Steripharm Pharmazeutische Produkte GmbH & Co. KG Production and marketing of pharmacy and prescription drugs, particularly plant-based steinerarznei-berlin.de drugs (tranquillizers, rheumatism drugs, bile duct and gastro-intestinal as well as gynecological and urological drugs), analgesics and mineral preparations. Production and marketing of folic acid products. steripharm.de Contract Manufacturers Advance Pharma GmbH ALPHAMADE GmbH Ayanda Chemisch-pharmazeutisches Labor, Rolf Sachse GmbH Haupt Pharma AG Pharma Action Spreewälder Arzneimittel GmbH Contract manufacturer of solid drugs.galenic development and admissions, analytics and advance-pharma-berlin.de microbiology, coating and granulation (organic and aqueous), compacting, packaging. Customized formulations as medications: parenteral feeding, intradialytic parenteral feeding, omega-3 fatty acids, cytostatics. alphamade.de Ayanda is an innovative business partner and manufacturer of consumer ready pharmaceuticals and food supplements. In Pritzwalk, Brandenburg, the company has a pharmaceutical ayanda.com soft gel encapsulation plant. CPL SACHSE offers: Custom synthesis development of active pharmaceutical ingredients cpl-sachse.de (API s); Contract manufacture of active pharmaceutical ingredients from laboratory to kiloscale; Pharmaceutical analysis. With nine production sites Haupt Pharma is one of the leading contract manufacturers haupt-pharma.de for pharmaceutical products in the world today. About employees produce for an established clientele of more than 200 important international pharmaceutical companies, amongst which 15 of the international TOP 25. Pharma Action has extensive expertise in global pharmaceutical marketing and manufacturing since 1988 and offers cutting edge API solutions to the pharmaceutical industry in Pharma-action.com Europe and abroad. Spreewälder Arzneimittel is a contract manufacturer of drugs, veterinary drugs, food supplements, diet foods and cosmetics in liquid, semi-solid and solid administration spreewaelder-arzneimittel.de forms. Contract Research Organisations analyze & realize ag analyze & realize ag is a leading CRO and consulting firm, which primarily give complete advice and guidance to companies in the natural products sector. analyze-realize.com 60

61 BioTOP-Report Contract Research Organisations Assign International GmbH BLS Preclinical Services Charité Research Organisation GmbH Cooperative Clinical Drug Research and Development (CCDRD) AG CSG Clinische Studien Gesellschaft mbh Dr. Notghi Contract Research Klinische Forschung Berlin GbR Klinische Forschung Gruppe Nord GmbH PAREXEL International GmbH Sacura GmbH Assign International in Berlin is part of the Assign Group, a mid-sized full-service CRO with assigngroup.com six offices in five countries.our expertise meets development requirements of pharmaceutical and biotechnological industries. We manage clinical trials from study set-up to final clinical report.our services, among others, comprise Data Management and Biostatistics, integrated EDC-Systems, Pharmacovigilance, Protocol Writing, Laboratory Services and Quality Management. BLS Preclinical Services is a contract research organization (CRO) located in Berlin. BLS provides a range of highquality and integrated preclinical services in animal models. Through bls-germany.com our highly skilled scientific partners we provide a one-stop service and tailored solution. We take the time to understand your business needs and provide comprehensive tailored solutions either in-house or in co-operation of our network. We are backed by a highly skilled scientific team with a wealth of experience in all disciplines of preclinical development. Based in Berlin, the Charité Research Organisation (CRO) was founded in collaboration charite-research.org with Berlin s famous Charité University Hospital. This relationship fosters a level of cooperation with centers of clinical excellence that we think is unique in the industry. The CRO offers a whole new approach to the concept of partnering with centers of clinical excellence to facilitate access to patients, clinical expertise and specialist methodologies in support of early clinical development programs. CCDRD is an independent contract research organization (CRO). CCRDR is dedicated to ccdrdag.com offer creative and innoative full service from planning to market authorization to its customers in the pharmaceutical, biotechnological and medical device industry. Since its foundation in 1998, the CSG Clinische Studien Gesellschaft mbh has focussed on csg-germany.com aligning clinical research with public health demands, with special attention to facilitating access by physicians and patients to clinical studies.csg cooperates closely with the largest research institute for public health in Germany, the IGES Institut. Dr. Notghi Contract Research GmbH is a service provider for large, medium and small-sized notghi.com companies in the pharmaceutical, generics and biotechnology industries. We support and advise you in the conduct and management of national and international projects. Klinische Forschung Berlin is a study centre that implements clinical studies from phases klinische-forschung-berlin.de IIA to IV for the pharmaceuticals industry. The Klinische Forschung Gruppe Nord (Clinical Research Group North) is a network of independent investigator institutes with five centres in Northern Germany, two of them in kfgn.de Berlin.The Klinische Forschung Gruppe Nord has carried out trials with up to 250 patients. Phase II and III studies are the core competence. The test centres have altogether 30 overnight accommodation places for phase I and IIa studies. The German subsidiary of the US clinical research organization PAREXEL employs more parexel.com than 1,400 people in Berlin. In two units with a 160-bed capacity (incl. 8 sleep lab beds) and an annual enrollment of approximately 2,500 volunteers in Berlin, more than 75 clinical studies are performed each year. Sacura is a full-service contract research organization granting a high level of quality (FDA sacura-cro.com approved), flexible structures and qualified staff. Biotech Companies 3B Pharmaceuticals GmbH 8sens.biognostic GmbH ABiTEP GmbH Accelero Bioanalytics GmbH 3B Pharmaceuticals GmbH (3BP) is a privately held pharmaceutical R&D company based 3b-pharma.com in Berlin, Germany. The company is dedicated to the development of peptide-based pharmaceutical and diagnostic products. 3BP is pursuing projects in hemophilia and nuclear medicine. 8sens.biognostic develops, produces and sells rapid tests (lateral-flow) and ELISAs for different markets (human and veterinary diagnostics, food control). Our products are the biognostic.de QuickSens -tests for h-fabp, TropI, CRP and hs-crp and the Reader for quantification QuickSens OMEGA. Development-on-demand, feasibility studies and production-on-demand are also offered. The ABiTEP GmbH is working in development and production of biotechnological products abitep.de for sustainable agriculture. The team of ABiTEP works for development of non GMO customer specific technologies in laboratory scale and scale up with modern equipment and Know how. Capacities for fermentation up to L, down stream equipment as well as freeze drier with capacity of 90 L are available for services. A molecular biology lab is available for basic science. Accelero Bioanalytics GmbH is a biotech CRO focussing on GxP compliant bioanalytical accelero-bioanalytics.com ligand binding assays. The company supports PK and PD preclinical/ clinical drug development on microrna, mirna, sirna, aptamers, plasmid APIs, antisense drugs, as well as peptide hormones, biosimilars, antibody therapeutics, or cell-based therapeutics (ATMP). The Applied Biosystems Viia7 real-time qpcr system with IVD label for human Dx operates in full compliance to Good Laboratory Practice (GLP). 61

62 BioTOP-Report Biotech Companies Adrenomed AG Development of biologics against severe sepsis. adrenomed.com Aevotis GmbH The core competencies of aevotis lie in the targeted conversion of simple carbohydrate aevotis.com containing substrates (e.g. agricultural by-products, waste streams, inexpensive sugars) to high-value carbohydrate based products, their characterization, processing and testing. Marketable products include novel /optimized enzymes, expression systems,&nbsp, specialized biotransformation and down-stream processes, customized oligomers and polymers for food and non-food uses. AFOSA GmbH Development, production and marketing of diagnostics (ELISA kits), primarily for use in afosa.com veterinary medicine. Aglycon Mycoton GmbH Aglycon Mycoton GmbH is active in the research, development and application of biopolymers aglycon-mycoton.net as well and their manufacture and the sales and marketing of products based on these. AJ Innuscreen GmbH The AJ Innuscreen GmbH is a young life science company working in the field of biotechnology aj-innuscreen.de and boosts the life science unit of Analytik Jena AG. Innovative technologies and products are developed and produced for the isolation and purification of nucleic acids. Reagent systems for molecular biology, as well as technologies and products for molecular diagnostics, are also included in the product portfolio. The company is EN ISO 9001:2008 and EN ISO 13485: AC:2009 certified. Alacris Theranostics GmbH Alacris Theranostics GmbH is a company based in Berlin specialised in developing new alacris.de approaches in personalised medicine for cancer patient diagnosis, treatment and drug stratification. Alacris is applying a systems biology approach that has been developed in the Department of Prof. Lehrach at the Max Planck Institute for molecular Genetics and is exclusively licensed as ModCellTM to Alacris. Alcat Europe GmbH Alcat Europe GmbH is the daughter of the US company Cell Science Systems, the original alcat-europe.com developer of the Alcat test technology. The company is specialized to identify intolerant reactions of the leucocytes to foreign substances like foods, drugs or chemicals. Algenol Biofuels Germany GmbH The company focuses on the biotechnological use of cyanobacteria, especially the development algenol.com and optimization of cyanobacteria for the production of environmentally friendly biofuels and chemical feedstocks. ALRISE Biosystems GmbH ALRISE is a drug delivery company that specializes in the nano- and micro-encapsulation of alrise.de active ingredients. Using its globally patented ImSus technology, ALRISE are developing parenteral deposit pharmaceutical forms for proteins, peptides or small molecules. Customers are mainly large pharmaceutical companies who are developing improved administration forms for active ingredients whose patents are expiring together with ALRISE as part of their Product Lifecycle Management. Amocol Bioprocedures Ltd. Amocol Bioprocedures Ltd is a life science research & development and manufacturing amocol.com company headquartered in Germany. Our mission is to supply innovative affinity chromatography media products and protein purification tools for research scientists and clinical customers in public sector institutes and industry. AnaKat Institut für Biotechnologie AnaKat Institut für Biotechnologie GmbH has specialized on analytical determination of anakat.de GmbH pharmaceutical ingredients. Analyticon Discovery GmbH AnalytiCon is a biotechnology company focusing on the development of compound libraries consisting of natural product (NP) and synthetic small molecules. As the global market leader in NP small molecule screening compounds, AnalytiCon is the only company which is able to provide vast collections with completely disclosed structural information. As a pure compound provider the company is offering its products and services to the pharmac., chemical, biotech, cosmetical and nutraceutical industry. ac-discovery.com Analytisches Zentrum Biopharm Berlin GmbH AnaTox GmbH & Co. KG Anau Berlin-lab GmbH ANiMOX GmbH Aokin AG Analytisches Zentrum Biopharm GmbH Berlin is a contract research organization providing services on pharmaceutical analysis and bioanalysis for active compounds in the dosage form, for the quantitative determination of analytes in a biological matrix and also the determination of physicochemical parameters of chemicals according to OECD guidelines. AZB carries out these services in compliance with GLP and GMP and has the GLP certificate. analytisches-zentrumbiopharm.de The AnaTox GmbH & Co. KG deals with the development and optimization of analytical anatox.de methods and devices for HPLC and dissolution. Development and distribution of lab devices. Development of applications for the use of natural peptide / amino acid mixtures in chemistry and biotechnology, f.i. as a scavenger material in formaldehyde bounded formulations, animox.de foaming or hydrophobic Tensid compounds or as a N-source in biotechnological fermentation processes, distribution of a technology for the production of such basic materials from raw and residual materials. Aokin AG is a Berlin biotechnology company that is specialized in the development and aokin.com commercialization of innovative analytical systems on the base of the rapid kinetic assay technology. The aokin systems are unique in their precision and operating speed. Areas of application are food and antibody analytics as well as clinical diagnostics. We also offer laboratory services in the area of food analytics, Pharmacoanalytics and chemical synthesis. 62

63 BioTOP-Report Biotech Companies AptaRes AG ARGUS Umweltbiotechnologie GmbH ASCA GmbH Angewandte Synthesechemie Adlershof Astra Biotech GmbH ATLAS Biolabs GmbH Attomol GmbH Molekulare Diagnostika AudioCure Pharma GmbH AutoTissue GmbH Bbi-biotech GmbH BEB BioEnergy Berlin GmbH BG Berlin-Genetics GmbH Bioanalyt GmbH Bioassays GmbH Biochrom AG BIOCYC Gesellschaft für Biotechnologie und Recycling mbh & Co.KG AptaRes is a developer and manufacturer of aptamers as an alternative to antibodies. The aptares.de aptamers are isolated in vitro by using a proprietary technology. AptaRes is also developing aptamer-supported processes and analytical methods. It provides also consumables required for the aptamer applications. In collaboration with financial partners AptaRes supports with its enabeling technology entrepreneurs and the expansion of biotechnology companies. ARGUS is a medium-sized company. Since 1987 ARGUS works on the field of remediation argus-umwelt.de of contaminated groundwater, soil, waste water and waste air. ARGUS is able to elaborate a specific remediation program in each different pollution case considering economic aspects beside ecological aspects. All necessary treatment steps can be planned and carried out. The combination of microbiological steps with classic processes leads to a successful remediation of complex contamination. ASCA is a partner for contract research in the field of medicinal chemistry. The synthesis asca-berlin.de and optimization of lead structures, the development of new active structures and their check on a laboratory scale are offered. We take a lot of care on working out the synthetic schemes, rapid preparations and exact analysis of the samples. All our results are carefully documented for our customers. Access to literature databases and in-house analytical facilities are available. Astra Biotech GmbH offers high quality reagents, allergens, antibodies, recombinant proteins, and assays for the determination of hormones, allergies, tumour markers and infec- astrabiotech.de tious diseases. Quality is one of the key cornerstones on which Astra Biotech maintains its reputation and with which we strive to increase customer satisfaction and gain growing customer loyalty. We take great pride in our highest quality assays, which are all IVD compliant and therefore suitable for direct, accurate and reproducible diagnostic purposes, as well as for research. ATLAS Biolabs GmbH is a leading provider of microarray based genomic services such as atlas-biolabs.com genome wide gene expression and SNP analysis, CGH analysis and diagnostic services for registered doctors and hospitals, as well as for pharmaceutical, biotechnological and diagnostic enterprises. The company s aim is to develop, produce and distribute medical diagnostics for human attomol.de medicine in the field of molecular genetics, infectious and autoimmune diseases. AudioCure is focus on the clinical development of drug candidates for neurodegenerative audiocure.de diseases with high unmet medical need. The company is engaged in the development, production and marketing of medical devices autotissue.de for cardiovascular surgeons. The products are specially made for the patients and have less side effects. The first certified product was a pulmonary heart valve (Matrix P) for the right ventricular outflow tract reconstruction (RVOT). The second product is also a heart valve which considerably shortens the operation time (Matrix P plus). Meanwhile a complete glutaraldehyde free valve is available called Matrix P plus N. In the focus of the activities of bbi-biotech lie systems for the sterile sampling from bioreactors for all applications in the biotechnology, pharmaceutical, food, cosmetics and bbi-biotech.com chemical industry. In addition, bbi-biotech develops components - in especially disposable ones - for the preparation of a new generation of fermentors and bioreactors and offers consulting and planning services for biotech projects, its implementation and services. Planning, Design, Construction, Supervision and Implementation of Biogas/Hydropower bebgmbh.de plants, Preplanning, Feasibility Studies and Research activities in the field of renewable energies, Optimization of the process in existing biogas plants. BG Berlin-Genetics GmbH is a new provider for genetic diagnostics and consulting in genetic diagnostics. We are a team of experienced human geneticists and have worked for bg-berlin-genetics.de many years in the field of human genetic science and human genetic diagnostics. Our aim is the development of innovative cooperation concepts, to connect classical patient-based medical care centers with modern technology-based service centers. In future, these cooperation forms will enable efficient, high quality, and patient-based genetic diagnostics. Bioanalyt develops and distributes the worldwide first easy-to-use and portable test kits for bioanalyt.com the analysis of vitamins and micro nutrients. The icheck-iex test kits enable food producers, food authorities and NGOs to monitor their ongling food programms more efficiently and at low-cost. The company was founded in 2006 by Prof. Dr. F. J. Schweigert as a spin-off of the University of Potsdam. Read more on our website Service related to the development of medical in vitro-diagnostic products. Basic science bioassay-online.de to clinical development. Profiling of biomarkers in clinical trials. Biochrom is Germany s largest manufacturer of cell culture products (media, sera, and biochrom.de others) and sterile liquids. They are distributed to universities, industrial cell culture laboratories and industrial manufacturers. Service is of special significance for users of cell cultures. Special media developments and production optimizations are offered. Production of bio-chemicals, peptides, in vitro-diagnostics, test-kits. Development of consumer service for peptides and quartett.com biochemicals. 63

64 BioTOP-Report Biotech Companies BioGenes GmbH Bioline GmbH BioMedion GmbH Biorefinery.de GmbH BioRepro GmbH BioS Biotechnologie Schönow GmbH BioSilta Europe GmbH BIOSYNTAN Gesellschaft für bioorganische Synthese mbh Biotech-Laboratorium für Environment BLE GmbH biotechrabbit GmbH BIOTECON Diagnostics GmbH BioTeZ Berlin-Buch GmbH BIOWORX -Biotechnologielabor- Thomas Grimm BiRDS Pharma GmbH Blue Biolabs GmbH BioGenes is a full service immunoassay and antibody (monoclonal and polyclonal) development company with outstanding problem solving capabilities specializing in challenging biogenes.de projects that are carried out by an exceptionally experienced and interdisciplinary team. Our mission is to provide customers with a range of products which are fast and easy to bioline.com use, guaranteed to work and developed by scientists who understand what our customers are trying to achieve so they can focus on their scientific goals. Bioline reagents are used by molecular biologists and other research scientists to perform test-assays and research in many fields from medical, biotechnology and marine biology. IT-Service for all GxP-Regulatory Tasks Data- and Document Management, Long-Term-Archiving and Digital Signature, SOP-Management, CAPA, Raw Data Management, Consult- biomedion.com ing for Validation of Computerized Systems according to GAMP4/5. Based on main precursors of plants, carbohydrates in kind of sugar, starch and cellulose, biorefinery.de and proteins, the biorefinery.de company has developed four complex product lines (Biorefinery systems) which leads to a great number of valuable products with the help of chemistry and biotechnology. BioRepro is the first pharmac. company, whose core competency is the breeding of leeches under controlled laboratory conditions for medical therapies. We concentrate on the biorepro.de establishment of GMP breeding procedures and will be able to provide leeches with standardized quality while equally allowing scalability to supply medical demand. Additionally, through the re-initiation of fundamental research, we will gain deeper understanding of further potential in medical and cosmetic treatment areas. Embryo transfer and associated biotechnologies in animals. Service, training and research bios-schoenow.de in this field. BioSilta is an international company that specializes in advanced tools for microbial cell biosilta.com cultivation, protein production, enzyme screening and food spoilage testing. The patented EnBase technology resembles fed-batch mode and provides a cultivation environment with glucose-control, ph maintenance and inhibition of growth-limiting metabolites without the need for traditional mechanical pumps. EnBase is provided in ready-to-use liquid or tablet products. BioSilta specializes in small-scale cultures and it?s products offer customer solutions from multi-well plates to small-scale bioreactors. Learn more about our products and applications at BIOSYNTAN offers the custom synthesis of standard peptides, the synthesis of modified biosyntan.de peptides (e.g. glyco- and phosphopeptides, dye labeled peptides) and hapten modifications for the conjugate synthesis. In cooperation with BIOGENES GmbH Berlin we offer poly- and monoclonal antibodies. Development of detection systems which are able, economically and rapidaly, to detect oil mobiclup.de contaminations and industrial oil waste, in soil and in water and their biological depletion. The BLE GmbH is concerned with the biological degradation of oil contaminations and the development of a set of bio-preparations consisting of different bacterial strains which break down oil. biotechrabbit GmbH is determined to offer the newest and best life science products and biotechrabbit.com innovative solutions to scientists leading the fight againstdisease and fueling our lives with innovations. We supply ultra pure enzymes and high-quality antibody services for diagnostics and a life science product portfolio(including reagents for PCR and nucleic acid purification)for molecular biology and proteomics. The biotechrabbit advantage is our combination ofpassion for excellent research with the agility of true entrepreneurship. BIOTECON Diagnostics has been well known as a qualified partner in the field of molecular bc-diagnostics.com and microbiology for the last 13 years. We focus on development, production and marketing of PCR-based rapid detection systems. BIOTECON Diagnostics offers solutions for the food and beverage industry as well as for producers of pharmaceuticals and cosmetics. Services (Custom DNA and RNA Oligonucleotide synthesis, Immuno affinity columns) - Development of Enzyme Immunoassays, e.g. for Therapeutic Antibodies- Bio Conjugates - Im- biotez.de mobilization of Bio Molekules for better Signalling-R&D (Aptamer). BIOWORX offers services in the fields of contract research for customer-specific Biotransformations, the screening, isolation and production of Biocatalysts from microorganisms bioworx.de and plants and the bioanalytic syntheses. Further organic compounds and metabolites will be synthesized with enzymes for customer in kg scale. BiRDS Pharma GmbH, integrated into the BDD/CCDRD group, provides services in the field birdspharma.com of drug development to pharmaceutical and biotech companies, including management of drug development projects as well as consulting services. The company also pursues own drug development projects based on intellectual property generated within BDD/CCDRD group, with a focus on drug candidates derived from Atomic Substitution Technology (AST). Blue Biolabs is a spin-off company from the TU-Berlin, which specialises in the development of products and services in the field of environmental analysis using methods of bluebiolabs.de microbiology and molecular biology. 64

65 BioTOP-Report Biotech Companies Botiss medical AG Breecon GmbH BST Bio Sensor Technology GmbH Caprotec bioanalytics GmbH Capsulution Pharma AG Celares GmbH CellServe GmbH CellTrend GmbH Chemicell GmbH Chipron GmbH CHIRACON GmbH CMZ-Assay GmbH co.don AG Botiss biomaterials is a privately owned biotech company, headquartered in Berlin. botiss is the leading German specialist for dental bone and tissue regeneration (BTR). We focus on the development of innovative regenerative materials and clinical marketing / distribution in over 50 countries world-wide. The botiss subsidiary Cell+Tissue Bank Austria is a leading European manufacturer of allogenic materials for hard tissue regeneration. botiss.com The breecon GmbH is an innovative service company in life science with focus on green breecon.com biotechnology. The objectives of the company are consulting, application and mediation of biotechnological-analytical services as well as their development and marketing. The breecon GmbH offers his services to plant breeders and companies of the industrial biotechnology and supports the utilization of genetic diversity in the context of SMART breeding. BST develops and produces biosensors to provide high quality analysis at moderate prices. In 1982 BST brought on the market the first multi-way biosensor based blood glucose analyzer in Europe and is since then market leader in Europe. Today BST sells more than sensors a year. Since 2008 BST is besides biosensors also manufacturer of POCT and laboratory instruments. bst-biosensor.de Caprotecs Capture Compound Mass Spectrometry (CCMS) Technology allows separation caprotec.com and isolation of proteins based on functionality. For many applications, CCMS is clearly superior to conventional methods - thus addressing an unmet need in the proteomics research community. The company is commercializing the CCMS technology through ImproMed projects with pharmaceutical and biotechnology companies. The focus on these collaborations is on investigating mechanisms of drug action (MoA) and identification of on- and off-target proteins to understand potential adverse effects of drug candidates on a molecular level. This can be easily carried out in the lead optimization process, or even earlier to increase the probability of success later on in the clinic. Capsulution Pharma AG develops innovative nano- and micron-sized capsules. The company applies its worldwide-patented so-called LBL-Technology. Based on their minute capsulution.com size, their functionality and their highly reproducible production process the capsules can be used for a multitude of different applications. Accordingly, the precisely sized capsules (500 nm to 50 µm) can be made to function in a manner to suit the intended application, and can be given the appropriate biochemical, electrical, optical and magnetic properties as required by the customer. Specialist for Drug Delivery of peptides/proteins by using PEGylation. Modification of celares.com Biopharmaceuticals with polyethylene glycol in order to substantially improve pharmacological properties. Offers the unique CelaSYS-PEGylation technology, which is patented by celares. CelaSYS: non-dispersed, highly branched polyethylene glycol based reagents. Additionally celares offers customized PEGylation solutions as well as synthesis of customized PEG-reagents. CellServe is a service provider for research groups in regenerative medicine and fills an cellserve.de important gap in the conversion of applied treatment concepts from research into marketable products. Furthermore CellServe develops own innovative cell-based products for cardiology and uses novel cardiac derived cells ("From the Heart to the Heart") for the treatment of chronic heart failure. Celltrend is certified according to ISO 9001, ISO and GMP Cell culture systems for celltrend.de research on active substances (bioassays, preclinical research, for quality control)development and production of antibody-based detection systems (ELISA) Chemosensitivityassay for optimisation of chemotherapy (tumor patients). Chemicell develops and produces magnetic, fluorescent and coloured nano- and microparticles, reactive fluorescent dyes and special chromatography-materials for the separation or chemicell.com detection of cells, bacteria, viruses, proteins or DNA/RNA and new gene transfer systems. Chipron GmbH specializes in production and distribution of array based detection systems chipron.com for DNA/pathogens. chiracon is a qualified partner to develop chiral intermediates at a constant high quality for innovative drugs regarding economic, environmentally acceptable and scaleable chiracon.de aspects. We offer support through expert knowledge and key technology to meet your increasing needs. Our core competence is chirality. In addition we have a broad variety of chiral building blocks as an inhouse raw material source for high-level API production and development. Marketing of diagnostic reagents for measuring concentrations of proteins, hormones and cmz-assay.com their isoforms, exclusively for research purposes. co.don AG is one of the leading biopharmaceutical companies in the area of Regenerative codon.de Medicine/Tissue Engineering. Since 1997, co.don AG has developed, manufactured and distributed human Tissue engineering therapeutics for the regeneration of articular cartilage and intervertebral discs. 65

66 BioTOP-Report Biotech Companies CONGEN Biotechnologie GmbH Cyano Biotech GmbH Diaglobal GmbH DIZG Deutsches Institut für Zellund Gewebeersatz gemeinnützige GmbH Drug Response Dx GmbH Dr. Götz Verfahrenstechnik Biotechnik Umwelttechnik Dr. Lerche KG Dr. Otto GmbH Dr. Rölleke Labor für Genetische Analytik GmbH DSM Biopract GmbH Durakult GmbH E.R.D.E.-AAK-Diagnostik GmbH EMP Biotech GmbH Epigenomics AG Epinamics GmbH Epiontis GmbH Epo Experimentelle Pharmakologie & Onkologie GmbH Eurovir Hygiene-Institut/Dr. Thraenhart CONGEN is specialized in food testing by molecular analytics based on DNA and RNA detection. CONGEN has been a pioneer for over a decade in the development and application congen.de of food and feed analytics by real-time PCR. The methods are available as complete analytic kit as well as a Service. Our mission is to serve the food industry with an excellent service and with standardized and reliable test kits in order to realize highest possible food safety and food quality. Cyano Biotech identifies and characterizes natural products from cyanobacteria and optimizes their pharmacological activities employing a biocombinatorial approach. The com- cyano-biotech.com pany conduct further development of identified lead structures till the preclinical phase. Development, production and distribution of in vitro-diagnostics for analytical purpose diaglobal.de and the distribution of medical products. DIZG German Institute for Cell and Tissue Replacement engages in cell and tissue preservation as well as in cell and tissue replacement, and provides tissue preparations of human dizg.de origin to clinics, teaching and research organisations. Further service is culturing of skin cells (keratinozytes) for serious burns and other skin defects not healing well or affecting large areas. DIZG supplies cell cultures to help avoid experimentation with animals e.g. in the cosmetics industry. "DRDx makes drug response predictable: Challenge and necessity of personalized medicine drdx.de and individualized therapies demand for convincing and reliable companion diagnostics. The first field of activity of DRDx is Rheumatoid Arthritis (RA). The goal of our company is the technical and clinical validation of an IVD test kit for the reliable prediction of therapy response to TBAs ahead of treatment. Contract research and contract manufacturing using bacteria, yeasts and fungi. drgoetz.de Innovative company engaged in development, production and marketing of specialized lerche-biotec.com microcapsules for bio- and medical technology - Development and production of novel DNA-Purification-Kits with proprietary technology - Production and marketing of microcapsules (LUMiTainer), microbeads and cell based sedimentation standards for blood analysis (Sedi-Val ESR standards) - Encapsulation of cells - Contract analysis for characterization of microcapsules, porous membranes and hollow fibres. Handling with research and development of ecological products its process of development also its production and marketing - Production and refinement of plantingredients dr-otto-gmbh.de - Operate an analytical laboratory of renewable resources and chem. Analysis. Dr. Roelleke is specialized on the identification of microorganisms, particularly in the area dr-roelleke.de of food safety. Furthermore, Dr. Roelleke is authorized expert on paternity tests for courts and the private sector. Service and Additives (enzymes, trace elements, microbes) for biogas and waste water dsmbiogas.com sludge treatmentenzyme analysis in agriculture industrycontract reserach feed additives. Durakult GmbH discovers and optimizes starter cultures and novel whole-cell catalysts for durakult.de customers in the food, chemical and renewable energy industries. durakult provides a new technology to explore microorganisms from natural untapped biodiversity for industrial applications. durakult stabilizes genetically manipulated cells which show weak growth or unstable metabolic properties and fits them to industrial purposes. E.R.D.E.-AAK-Diagnostik GmbH is a laboratory that offers antibody testing for commercial aak-diagnostik.de purposes. Production of fluorescent dyes and chemiluminescent reagents. Contract chemical synthesis of small molecules. Contract labeling and purification of proteins, antibodies and empbiotech.com oligonucleotides. Production of size-exclusion gels, columns and filter plates. Production of high quality reagents for DNA synthesis. Development and commercialization of innovative molecular diagnostic test products epigenomics.com based on DNA methylation for cancer screening and for cancer specialty applications. Epinamics GmbH, a newly established Berlin based pharmaceutical research and development dedicated company, is owner of a proprietary film forming formulation technol- epinamics.com ogy platform, the?invisible Patch? system. The system is offering a broad basis for the development of formulations for treatment of dermatological diseases as well as for the development of transdermal systems. Establishing methylation fingerprinting as Gold Standard for quality control in Regenerative Medicine and Immunomonitoring. epiontis.com The pharmaceutical and oncological testing of new drugs or treatment concepts for cancer epo-berlin.com is a specialized market segment. Using the equipment available, all experimental techniques can be carried out in first-rate quality. That means that EPO is an attractive partner for the drug development section of large pharmaceutical companies, for partners from the Biotech industry and for research institutions. Laboratory service for testing the efficiency of products against viruses (virucides) and of eurovir.de processes for inactivating or eliminating viruses (virus safety). 66

67 BioTOP-Report Biotech Companies EVESTRA GmbH F.A.T. Forschungsinstitut für Antioxidative Therapie GmbH Fermtec GmbH EVESTRA is a newly founded biotech company focusing on developing female health evestra.com products. The companies expertise resides with steroid chemistry and biology. EVESTRA s product pipeline includes products for contraception, hormone replacement therapy, gynecological disorders and hormon dependent cancers. Measuring instruments and kits for evaluating the antioxidant properties and the degree antioxidant-research.eu of oxidative damage in biological substrates. Development of non-alcoholic beverages, beers and beer mix beverages, lactic acid fermentation, innovative foods and beverages and auxiliary substances for the food fermtecgmbh.de industry. Ferropharm GmbH Development of very small super para-magnetic nano particles as contrast agent for MRI. ferropharm.de FILT Lungen- und Thoraxdiagnostik Development of innovative, non-invasive diagnostic methods in the area of respiratory filt.de GmbH diseases and allergies. Formula GmbH Galenical development of liquids and solid formulations Lyophilization Technolgy also formula-pharma.de apllicable for biochemical products Granulation, drying and coating using fluid bed drying-technology, tabletting Development and validation of analytical methods including UPLC Stability testing (ICH / GMP related to on going) Import of medicinal poducts from non-eu-countries, manufacturing, quality control (re-test) and release for market in accordance with 16 AMWHV for medicinal products and clinical supplies GMP-certificat / Manufacturing license in accordance with 13 AMG. GA Generic Assays GmbH Development, manufacturing and distributing of in vitro-tests, focussing on autoimmune genericassays.com diseases, hereditary and infections diseases. Gene Analysis Service GmbH Gene Analysis Service is specialized on genetic testing of a number of rare hereditary diseases and provides nucleic acid based molecular biological services like PCR and custom DNA sequencing for healthcare providers and research institutes worldwide. gene-analysis-service.de GenExpress Gesellschaft für Proteindesign GmbH GILUPI GmbH GlucoMetrix PVS GmbH Glycon Biochemicals GmbH Glycotope GmbH GenExpress is a flexible company providing services in molecular biology. For over a decade we have successfully worked for customers in clinical laboratories, research insti- genexpress.de tutions and the industry. We offer cloning of PCR targets, preparation of synthetic genes, expression of proteins, evaluation of LightCycler assays, furthermore production of internal controls and standards for Real Time PCR systems, also cloning, expression and purification of proteins. GILUPI is a medical diagnostics company with an initial focus on the prenatal and cancer gilupi.com market. The company is developing an innovative new diagnostic product based on nanotechnology. Our goal is to catch specific cells, which can be found only in very low concentration in the blood. The first application for our new nanosensor device will be prenatal diagnoses of chromosomal aberration out of maternal blood. The second application will focus on the early diagnosis of cancer. The GlucoMetrix AG focuses on the early detection and management of diabetes mellitus-aftermath. At the foreground of research and development is the enhancing the quality glucometrix.de of life of diabetics. In addition, the life science company develops some IT-based diagnostic procedures and medical devices as well as biopharmaceuticals and other highly effective products in order to raise the quality of life of diabetics sustainably. Production of carbohydrate components used for the synthesis of new pharmaceutical glycon.de compounds or diagnostics. Glycotope is a leading company in glycomics and immunotherapeutics. It has developed glycotope.com novel therapeutic antibodies and unique platform technologies to optimize the glycosylation of new biological entities. Glycotope Biotechnology, with 25 years of experience in GMP-production, enables us to offer the entire process of biopharmaceutical development with a dedicated focus on our unrivalled expertise in protein glycosylation from the gene to production and fill & finish of clinical grade material. Götz Protein Engineering Offering a wide range of protein technology up to the final purified protein. goetz-protein-engineering.de HealthTwiSt GmbH HealthTwiSt is a service provider for Genetic Contract Research in the fields of Functional healthtwist.de Genomics, Epigenetics, Proteomics or Functional Food / Nutriceuticals. In particular, HealthTwiSt is offering access to extensively characterized human subjects and samples as well as prospective studies in twins, together with know-how in the analysis of complex genetic traits. Furthermore, database development, data management and statistical analyses for clinical projects are provided. HF Biotec Berlin GmbH Development, selling and operating of digestion plants using liquid substrates of industrial hf-biotec.com and agricultural provenience, Development and operating of combined plants to upgrade biogas into bio methane useable in public gas grids with parallel production and selling of high quality PCC, Development of innovative biotechnological processes and plants. Human BioSciences GmbH The biotech-company Human BioSciences Inc. is specialized in manufacturing and distribution of modern collagen based wound and skin care products. HumanBioSciences.de 67

68 BioTOP-Report Biotech Companies HUMAN GmbH Hybrotec GmbH ICI GmbH Icon biotech IDrug GmbH Ifp Institut für Produktqualität GmbH IGV Institut für Getreideverarbeitung GmbH IKDT Institut Kardiale Diagnostik und Therapie GmbH ILBC GmbH ImaGenes GmbH In.vent DIAGNOSTICA GmbH inbion GmbH Innovative Optische Meßtechnik GmbH Institut für Medizinische Molekulardiagnostik (IMMD) GmbH Institut für Molekular- und Systemmedizin I.M.S.M. GmbH InterMune GmbH For over 35 years HUMAN has been serving the healthcare sector. HUMAN develops and human.de manufactures in Germany laboratory diagnostic products for the world market. HUMAN stands for quality and service in over 160 countries. In our new competence centre for autoimmune diagnostics, an expert team of highly specialized scientists and technicians develop and produce the IMTEC product line, a range of high-quality autoimmune diagnostic products. Further innovative products are to be launched soon! Hybrotec GmbH is specialized in the development of monoclonal antibodies and immunoassays (preferably homogenous assays) as customs service. Our main focus lies on antibod- hybrotec.com ies binding low molecular weight substances (e.g. toxins, fluorophores, hormones) as well as antibodies against novel proteins. ICI immunochemical intelligence gmbh is dedicated to the development and production of innovative immunoassay components and kits for research use. Their goal is to pro- ici-diagnostics.com vide individual solutions, exactly tailored to the client s needs and to create lasting relationships by providing outstanding services and high quality products to demanding clients. Icon biotech is an innovative biotechnology company, which uses the extraordinary characteristics of Ciliates for the development of bio-analytical and toxicological model systems. icon-biotech.com IDrug supports business strategies with innovative methodologies in analytical and biopharmaceutical chemistry idrug.de Ifp Institut für Produktqualität is a laboratory and competence centre for state-of-the-art produktqualitaet.com food, drinking water and pharmaceutical analysis. The accredited and GMP-certified company focuses on comprehensive services for the food and pharma industry. An additional core competence of ifp is the development and production of innovative diagnostics comprising the real-time PCR kits of the brand mericon (QIAGEN), vitamin tests in microtiter plate format, enzymatic microtiter plate kits for sugars/acids, and allergen tests in lateral flow and ELISA formats. The range of services offered by the Biotechnology Division of the private research IGV igv-gmbh.de GmbH institute is based on 25 years of experience in R&amp,D for the cultivation of phototropic micro-organisms. Excellent, world-wide contacts to biomass producers, food producers, to the pharmaceutical and cosmetics and energy industry provide the fundament for innovative, market-oriented developments. In focus are development of photo bioreactor technology and active substances from algae. IKDT was founded in August 2002 in Berlin-Steglitz and is one of the leading laboratories ikdt.de on Viral Infections of Heart Muscle Tissue and Dilatated Cardiomyopathy (DCM) in Germany. IKDT lab is performing a comprehensive molecular diagnostic examination of endomyocardial biopsies as one of a limited number of specialized cardiological labs worldwide. Its service enables physicians firstly to start an efficient, pathophysiologically based causal therapy. Research, consulting, production, trade & services in the areas biology, molecular biology mobiclup.de and protein chemistry - Expression and production of antimicrobial peptides. RZPD spin-off, today part of Source BioScience plc, a premier service center for genome imagenes-bio.de research and healthcare in Europe, provides one of the largest clone collections in the world via its clone search engine GenomeCube. Certified Service Provider for illumina Next Generation Sequencing services and comprehensive microarray application on Affymetrix, Agilent, and NimbleGen platforms. ISO 9001:2008 certified. in.vent DIAGNOSTICA GMBH is a biomedical company. We are focused on the project-oriented provision, processing and distribution of biological raw material for development inventdiagnostica.de and production of diagnostics and control material. We are your reliable partner for the customised development of assays for medical in vitro-diagnostics. inbion GmbH provides services to support research in the interface between university, inbion.de students and industry. For companies, we provide the benefit of outsourcing projects quickly and cost-efficiently to competent teams. Cooperation with research groups in the university is also facilitated, so that targeted knowledge transfer can take place here. Fluorescence Assay Solutions and Instrumentation (Microplate Readers). iom-berlin.de Gene tests for prenatal, predictive and tumor -diagnostics. Scientific-practical works in the area of System medicine with the purpose of the patenting of new treatment methods, e.g. to the treatment of diabetes. International cooperation in this area. immd.de InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and fibrotic diseases. In pulmonolo- intermune.de gy, we are focused on therapies for the treatment of idiopathic pulmonary fibrosis (IPF), a progressive and fatal lung disease. 68

69 BioTOP-Report Biotech Companies InVivo Biotech Services GmbH InvivoContrast GmbH JPK Instruments AG JPT Peptide Technologies GmbH Klinomed GmbH KNAUER - Wissenschaftliche Gerätebau Dr. Ing. Herbert Knauer GmbH L.U.M. Gesellschaft für Labor-, Umweltdiagnostik & Medizintechnik mbh Labor Berlin Charité Vivantes Services GmbH Labor Berlin Charité Vivantes GmbH LAROVA Biochemie GmbH LGC Genomics GmbH As a contract manufacturing company (CMO) Invivo offers a wide range of services: the invivo.de development and production of monoclonal antibodies and recombinant proteins for diagnostic and pre-clinical use (endotoxin-free antibodies and compliant documentation), cell line development and transient transfection. We are an ISO9001:2008 certified company. InvivoContrast provides globally high quality MRI (Magnetic Resonance Imaging) contrast invivocontrast.com agents and professional support for preclinical imaging in academic and commercial institutions. JPK Instruments AG is a world-leading manufacturer of nanoanalytic instruments - particularly atomic force microscope (AFM) systems and optical tweezers - for a broad range of jpk.com applications reaching from soft matter physics to nano-optics, from surface chemistry to cell and molecular biology. From its earliest days applying atomic force microscope (AFM) technology, JPK has recognized the opportunities provided by nanotechnology for transforming life sciences and soft matter research. JPT is an ISO 9001:2008 certified provider of innovative peptide products and services and jpt.com a partner for research projects focusing on the development of novel immune therapeutics & diagnostics, profiling of various enzyme classes and proteomics. JPT has developed a portfolio of proprietary technologies and a series of unique products which support a worldwide customer base. Since 2011 all catalog products such as peptide microarrays & peptide pools are avalaible through an online shop. Development of new technologies for manufacturing bio-active nano particles / development of therapeutic formulations based on nano particles. KNAUER UHPLC and HPLC systems as well as columns are used in research and development, quality control and production plant laboratories around the world. Customers are typically governmental and industrial organizations as well as universities. Fields of application are wide-ranging and include pharmaceutical and medical research, analysis of foodstuffs and cosmetics, as well as environmental analysis. With our biochromatography solutions we focus on high resolution separations. Analysis, diagnosis and sensor technology as well as stability, rheology and segregation behavior of dispersions. Labor Berlin Services is the service subsidiary of Europe s largest hospital laboratory for clinical pathology and offers complete solutions for any kind of testing for the ivd industry, CROs, the pharmaceutical industry, life science companies and research facilities, while Labor Berlin is the exclusive laboratory partner of Charité - Universitätsmedizin Berlin and the Vivantes Network for Health. Labor Berlin and Labor Berlin Services both perform over 35 million analyses in clinical pathology per year and provide the diagnostic services for approximately in-house patients a day and some one million out-patients per year. Research, development and production of nucleotides, nucleosides, oligonucleotides in natural and modified forms. LGC Genomics is the division of LGC with specific expertise in high quality, cutting-edge genomic and related services and products. LGC Genomics delivers:- Next generation sequencing services- DNA sequencing- Genomics services- Nucleic acid extraction services- DNA extraction products. LGC is an international science-based company and market leader in analytical, forensic and diagnostic services and reference standards ( klinomed.de knauer.net lum-gmbh.de laborberlin.com larova.com lgcgenomics.com LGC GmbH Production of calibration substances for purity testing of drugs. mikromol.de Limetec Biotechnologies GmbH The core competence lies in the development of high-speed and high-quality proof systems limetec-biotechnologies.de for the detection of pathogens, as well as in the allelic discrimination of hereditary diseases. All products are marked with the CE-Certificate. The second area of expertise is the creation of communication networks which connect out-patient and hospital patient treatments, intensify data exchange and provide information to all health institutions, thus establishing partner relationships between them. Lipidomix GmbH LC/MS/MS based high trouput analytic of lipid mediators and metabolites. Analytical method lipidomix.de development, analytical support for LC/MS/MS in life science, food safety, forensic sci- ence. MagForce AG MagForce AG is a leading medical technology company focusing on nanomedicine in oncology. magforce.com The company s proprietary procedure, NanoTherm therapy, enables the targeted treatment of solid tumors through the intratumoral generation of heat via activation of magnetic nanoparticles. NanoTherm, NanoPlan, and NanoActivator are components of the therapy and have received EU-wide regulatory approval as medical devices for the treatment of brain tumors. Marinpharm GmbH Development and marketing of genetically altered cell lines on the basis of new fluorescence marinpharm.com markers. Generation of stably transfected fluorescent cell lines. MedInnovation GmbH MedInnovation GmbH has developed a new method and a special ESR-analyser, which for medinnovation.de the first time allows a simple routine laboratory test for evaluation of functional characteristics of plasma proteins and further opens a reliable possibility for cancer diagnostic, named MMS-technology (mobility of molecular structure). 69

70 BioTOP-Report Biotech Companies Medipan GmbH MerLion Pharmaceuticals GmbH Merz Pharmaceuticals GmbH / Standort Potsdam Metabolomic Discoveries GmbH Metanomics GmbH Metanomics Health GmbH MetrioPharm AG Mfd Diagnostics GmbH MicroDiscovery GmbH Microparticles GmbH Minerva Biolabs GmbH mivenion GmbH MLB Mikrobiologisches Labor GmbH MolConcept GmbH Molnar-Institut für angewandte Chromatographie MOLOGEN AG Development, manufacturing and international distribution of radioactive (125J-IRMA) medipan.de and non-radioactive (Elisa) in vitro-diagnostic tests, covering the field of Autoimmunity, mainly in Thyroid and Diabetes Typ 1 and automated interpretation of cell-based immunofluorescence tests by the AKLIDES system. The business purpose of the Company is the research, production, optimization and the merlionpharma.com development by way of pre-clinical as well as clinical trials of new molecules for the treatment of infectious diseases. Merz is one of the leading research-based health care companies. Merz Pharmaceuticals merz.de has achieved a leading position in Alzheimer s research with the world s first drug for the treatment of moderate to severe Alzheimer s disease. With high quality products from tetesept and Merz Spezial, Merz is making a key contribution to health and wellbeing. Metabolomic Discoveries is an analytical service and research company. We provide mass metabolomicdiscoveries.com spectrometry based metabolite profiling and fingerprinting of biological material, as well as single compound measurements. Metabolite Profiling for identification of gene function relationship in plants, metabolite metanomics.de biomarkers and metabolic networks. Identification of metabolic biomarkers for pharmacology, toxicology, diagnostic and nutrition. metanomics-health.de MetrioPharm AG develops innovative therapies for infectious diseases on the basis of new metriopharm.com and innovative medicines. The mfd Diagnostics GmbH (BT Luckenwalde) is a life science research and development mfd-diagnostics.com company for diagnostic and therapeutic application of innovative laser technologies. The main advantages of the developed technologies are the non-/minimally-invasive measurement methods, the non-artificial approach and the possibility of real-time measurement. Therefore, those are promising tools for the diagnosis and therapy monitoring in the neurological practice and in the perinatal surveillance. MicroDiscovery GmbH is a leading provider of high quality software for biomolecular research, innovative diagnostics and personalised medicine. The company is ISO 9001 certi- microdiscovery.de fied and has a strong track record in creating software systems in accordance with relevant regulatory directives for the life science and IVD industry. Customised services ranging from biostatistical data analysis to bioinformatical design and support of complex research projects complete the product line of MicroDiscovery. Development, manufacture, surface modification and characterization of mono-disperse microparticles.de polymer particles in the nano- and micrometer range. In addition to classic polystyrol and polyacrylate-based polymer particles, microparticles GmbH has launched new melamine resin particles on the market with exceptional chemical and physical qualities. The main areas of application are in particle measurement technology, medicine, biochemistry and microelectronics etc. Minerva Biolabs develops and produces IVD kits for diagnosing pathogens and for contamination control, especially mycoplasma in cell cultures and biopharmaceutical products. minerva-biolabs.com Minerva Biolabs is also active in ensuring water quality with sensitive processes for detecting legionella. Our distributors ensure that our products are available worldwide, quickly and at a good price. mivenion is a life-science company founded in Berlin aiming on the development and mivenion.com commercialization of diagnostic and therapeutic products. The company is built on two innovative technologies: the fluorescence camera system Xiralite for diagnostic imaging of early rheumatoid arthritis and a proprietary bioactive polymer drug development platform. Xiralite is mivenion s first product on the market. Accredited test laboratory for drinking water, clean rooms, sterility, bioburdens, mikroberlin.de D-PL , EN Accreditation according to VDI We offer computational drug design, rational drug design, and efficient simulation algorithms for molecular systems. molconcept.com Molnar-Institute, established in 1981, offers you a complete scientific and technical service for all problems concerning Quality by Design (QbD) for HPLC-methods. We develop molnar-institute.com for you the Design Space for your HPLC-separation and establish Critcal Quality Attributes (CQA s). We offer detailed DryLab-courses and show you, how to develop robust methods in the Design Space and how to save time. We supply and implement the DryLab-software and train your coworkers. We assist you in automated method development processes and support you in the selection of proper instruments, their installation and use. MOLOGEN AG is a biopharmaceutical company based in Berlin and specializes in the development of novel DNA-based medicines against cancer and vaccines against infectious mologen.com diseases. The proprietary platform technologies MIDGE and dslim build the foundation for all business activities. The company was founded 1998 and was one of the first biotechnology companies to go public. 70

71 BioTOP-Report Biotech Companies molox GmbH MRI.TOOLS GmbH Nano Access Technologies Ltd. Nanolytics Gesellschaft für Kolloidanalytik mbh Nanopartica GmbH nanopet Pharma GmbH New Medical Enzymes AG NovaBiotec Dr. Fechter GmbH Novamol GmbH NOXXON Pharma AG NutriNeu GmbH OakLabs GmbH OctreoPharm Sciences GmbH molox GmbH is a company focusing on custom protein production in bacterial and insect cell expression systems and subsequent protein purification to ultra-high purity. On molox.de customer demand a team of experts can perform protein crystallization experiments and determine the 3D structure of target proteins by X-ray crystallography. MRI.TOOLS s main focus is the development, sales and services of innovative hardware mritools.de and novel technology for magnetic resonance imaging (MRI), computed tomography (CT) and positron emission tomography (PET). Our product portfolio encompasses enabling radiofrequency (RF) coils tailored for a broad range of applications, devices designed for reliable cardiac gating of imaging plus accessories that will make your daily life more comfortable. MRI.TOOLS is also very proud to offer consulting services such as validation and certification of medical devices. The company addresses the combined access to key technologies such as life science and nano-access.com nanotechnology. As a first product, a low cost AFM for operation with so-called active cantilevers has been developed. Besides this, functionalized cantilevers for future biosensors are another focus of the company. We are a contract laboratory specializing in the physico-chemical characterization of pharmaceutical proteins, biopolymers, nanoparticles and colloidal systems. Our core-compe- nanolytics.de tences are Analytical Ultracentrifugation, in combination with Static and Dynamic Light Scattering as well as spectroscopic (CD, fluorescence) and thermodynamic techniques (ITC, DSC). Nanopartica GmbH optimizes existing products of other companies, but are also developing new products and materials. In particular, companies in surface-, bio-, and medi- nanopartica.com cal-technology can benefit from nanopartica. By means of functionalized polymers, we can encapsulate guest molecules (drugs, dyes, vitamins), particles (gold, silver, platinum), or ions. This will indirectly change the guests properties and expands its scope. As a technology and service provider to the biopharmaceutical industry nanopet focuses nanopet-pharma.com on the R&D, production as well as marketing of innovative drug substances for diagnostic imaging based on novel nanoparticular materials. nanopet offers consulting and contract research services, preclinical contrast agents (MRT, CT, US, NIR, PET) as catalog items and pursues the preclinical development of its patented core technology of inorganic nanoparticle PET tracers. Medical Enzymes AG is a privately held innovative biopharmaceutical company with a focus on therapeutically useful enzymes. The company has developed a new product family medical-enzymes.com based on amino acid depleting enzymes. This unique approach is highly effective against cancer - the major target market of Medical Enzymes AG. Microbiological and chemical investigations, in particular of soil, water and air samples, novabiotec.de planning / inspection of sanitation, in particular analytics and sanitation support for mould and dry rot, incl. education in this field. Delivery of production auxilliaries and support for biogas plants with biological treatment processes incl. application, insulation and preservation of enzymes. Research, development and marketing of test kits for breweries and malthouses. Development and manufacture of human and veterinary food supplements and health-enhancing products. novamol.com NOXXON Pharma is a biopharmaceutical company pioneering the development of a new noxxon.com class of proprietary therapeutics called Spiegelmers. Spiegelmers are the chemically synthesized, non-immunogenic alternative to antibodies. NOXXON has a diversified portfolio of clinical stage Spiegelmer therapeutics: Spiegelmer NOX-E36, Spiegelmer NOX-A12, Spiegelmer NOX-H94. The Spiegelmer platform provides the Company with powerful and unique discovery capabilities, which have generated a number of additional leads under preclinical investigation. Located in Berlin, Germany, NOXXON is a well financed mature biotech company with a strong syndicate of international investors, approx. 60 employees and a highly experienced management team. NutriNeu GmbH develops a new generation of pre and probiotics. First products are based on microorganisms that were isolated with our proprietary GlycoScreen technology (antibody directed isolation of microorganisms expressing specific carbohydrate structures). Besides developing own products, NutriNeu GmbH offers services in the fields of microbiology, process development and Glycoanalytic. NutriNeu GmbH also helps customers to investigate the probiotic properties of their microorganisms. OakLabs provides the most flexible products and services for large scale custom SNP genotyping on the market. OakLabs offers several formats for analysing a variable number of oak-labs.com SNPs in any sequenced organism. OctreoPharm Sciences GmbH is a clinical development company focusing on diagnostic octreopharmsciences.com radiopharmaceuticals. 71

72 BioTOP-Report Biotech Companies OpTricon Entwicklungsgesellschaft für optische Technologien mbh ORGANOBALANCE GmbH ORGANOBALANCE Medical AG ovalehn GmbH Pentracor GmbH Peptides&elephants GmbH PharmaSol GmbH PlasmaChem GmbH PolyAn, Gesellschaft zur Herstellung von Polymeren für spezielle Anwendungen und Analytik mbh Preclinics Gesellschaft für präklinische Forschung mbh Predemtec GmbH ProBioGen AG ProteaImmun GmbH PROTEKUM - Umweltinstitut GmbH, Oranienburg OpTricon develops and produces mobile readers for quantitative analyzes of Immunoassays for Point-of-Care-diagnostics, especially Lateral Flow Assays (LFA). Additional busi- optricon.de ness segments are components and Systems for signal transmission and sensors for lbioanalytics. optricon develops the devices in partnership with the customers and works as OEM-suppliers and is certified by TÜV Rheinland according EN ISO 13485:2003+AC: 2007 and EN ISO 9001:2008. ORGANOBALANCE is a company specializing in microbial strain development and screening. As a R&D contractor ORGANOBALANCE develops new biological products in the areas organobalance.com of nutrition, personal care and health care. The company draws on its own collection of microbial strains suitable for food applications and its OASSYS bioassay systems. In the field of metabolic engineering ORGANOBALANCE exploits Saccharomyces cerevisiae yeast for synthesis of substances for the industrial and pharmaceutical industry. ORGANOBALANCE Medical AG funds and promotes the research and development of novel therapies based on specific probiotic cultures, aiming to develop active substances and organobalancemedical.com mechanisms for innovative medicinal products and medical devices, as well as offer new therapeutic concepts for hitherto inadequately treatable indications. Production and application of specific recipes -containing IgY for diagnostics and oral, passive immune therapy. ovalehn.de In the case of cardiac infarction, C-reactive protein (CRP) results in an increase of the primary damage. Based on a new prototype, the company Pentracor GmbH aims to develop pentracor.com an adsorber for therapeutic reduction of CRP, lead it to approval, establish its certified production and market the product after clinical validation. Custom synthesis of peptides and peptide libraries Development parallel Synthesis technologies Distributor of Peptide Synthesis Automation. peptides.de Modification of ingredients or introduction of new metabolic pathways in plants with pharmasol-berlin.de gene-technology methods. PlasmaChem GmbH is an innovative R&D and manufacturing company specializing in plasmachem.com nanomaterials, plasma- and ultra-thin film technologies. The company manufactures nano-coated medical implants (stents), nanomaterials, additives for metal plating (applied e.g. by Siemens AG), new additives to engine oils on the base of nanodiamonds and other industrial nanoproducts. PolyAn is specialised in Molecular Surface Engineering (MSE). Using our surface modification expertise PolyAn optimises the performance of analytical systems by improving the poly-an.de signal-to-noise ratio as well as the reproducibility of consumables for multiplex diagnostics, LifeScience research and screening applications. PolyAn?s product portfolio includes functionalised microarray slides, microparticles for multiplex bead arrays and functionalised membranes for medical diagnostic applications. Preclinics is a commercial cooperation partner for preclinical research and development. preclinics.com As a competent, creative and experienced partner preclinics investigates pharmaceutical substances, therapeutic methods and proceedings as well as medical products during the preclinical phase. Additional we provide custom antibody production in llama, goat, sheep, rabbit and other species. Predemtec GmbH is a company focused on the research, development and manufacture of predemtecdx.com innovative diagnostic tests for use in the detection of dementia-related risk factors. The goal has been to make the early and reliable diagnosis of various dementia-related illnesses a reality through the use of our innovative diagnostics tests. ProBioGen is a Contract Development and Manufacturing Organization (CDMO) and Technology Provider, with extensive expertise in cell line engineering, process development probiogen.de (upstream- and downstream process) and GMP manufacturing of biopharmaceuticals. Offering state-of-the-art contract development and manufacturing services as well as access to proprietary cell lines (AGE1.cell lines ) for the manufacturing of biopharmaceuticals and vaccines. The company possesses the manufacturing authorization from the competent authority and meets the quality standards required by the EMA and the FDA guidelines. ProteaImmun is a specialized proteomic company providing purified human proteins, antibodies and ELISAs. Our proteins are designed for structural and functional studies of proteaimmun.net proteases screening and evaluation of protease inhibitors and modulators. Furthermore we develop highly sensitive ELISA kits and antibodies. Our Focus: MMPs, ADAMTs, HtrAs. ProteaImmun produces a unique range of recombinant proteases for medical and pharmaceutical research. The main focus is on human Matrix Metalloproteases (MMPs), ADAMTS and HtrA proteins which play an important role in neurodegenerative disease, ancer and arthritis. Customer Service: ProteaImmun provides activity analysis by zymography adapted for MMPs. We plan to eliminated fluid und solid waste products in a manner which is compatible with protekum.de environment protection. Our methodology is largely based on painstaking analysis. We use modern equipment and scientific methods. Protekum offers high-quality products and services in environmental analysis redevelopment. 72

73 BioTOP-Report Biotech Companies Proteome Factory AG Provitro GmbH Rapidozym Gesellschaft für Laborhandel und DNA Diagnostika mbh RENESA UG (haftungsbeschränkt) RiNA GmbH RIPAC-LABOR GmbH RNL Europe GmbH Roboklon GmbH ROVALAB GmbH Royal Biotech GmbH Scienion AG Sepiatec GmbH Seramun Diagnostica GmbH SGS INSTITUT FRESENIUS Berlin GmbH & Co. KG SIFIN Institut für Immunpräparate und Nährmedien GmbH Berlin Signature Diagnostics AG Biomarker & target discovery, validation, analysis of food and ingredients, absolute quantification of proteins and peptides, sequencing and characterization of proteins and an- proteomefactory.com tibodies (CDR), 2DE and LC-MS based proteomics studies, pharmacokinetics, pharmaco, immuno and membrane proteomics, protein identification, characterization of proteins and peptides (PTMs, e.g. phosphorylation, glycosilation), quality control, mass determination, N-terminal amino acid sequencing, silver staining kit etc. Provitro combines more than ten years of experiences in commercialisation of cell culture provitro.de technologies, Tissue Microarrays and immunohistochemical analyses with the scientific expertise of the Pathological Institute of the Charité, Berlin. Based on a quality management system according to ISO 9001:2008, we provide our customers not only with high-quality products, CE marked in vitro-diagnostics and state-of-the-art services but also with individual solutions for their specific requests. Expertise of cell biologists cell manufacturing and clean room technology specialists. Focuses on clinical stem cell product development portfolio are stroke, myocardial infarction rapidozym.de and plastic surgery. Manufacturing and distribution of rapid tests, mainly for medical purposes (Point of Care renesa.de Testing). RiNA has developed systems for cell-free protein biosynthesis based on pro- and eukaryotic cell lysates. A synthesis service is realised in RiNA s own laboratories and complements rina-gmbh.eu the EasyXpress Kits (Qiagen). The purchase of Roche s RTS-products enables RiNA now to be a key player in the field of cellfree biosynthesis with a large variety of products. Another research focus is the development of aptamers (DNA and RNA) for biosensors. RIPAC-LABOR offers high-quality diagnoses of bacterial infections, particularly in poultry, ripac-labor.de pigs and cattle, but also in other farm and domestic animals. The company uses pathogen differentiation to provide quick and effective methods for fighting pathogens. It performs resistance tests and epidemiological analyses and also focuses on producing herd-specific vaccines. Manufacturing of stem cells from bone marrow and adipose tissue for therapeutic and rnleurope.com plastic-aesthetical application. Manufacturing of adult stem cells for research (mesenchymal stem cells, endothelial precursor cells). Banking of stem cells. Distribution, Marketing and Development of Products for Molecular Biological Research roboklon.de and Genetic Engineering. Our Master Mixes for QPCR, Standard-, Hot Start- and High Fidelity PCR as well as our rovalab.com high quality critical raw materials and reagents such as DNA Polymerases and dntps are designed to help you successfully and rapidly solve your scientific and manufacturing tasks. Royal focuses on developing, manufacturing and marketing innovative kits, portable or royalbiotech.com micro-structured systems, and the next generation of diagnostic chips for near real-time environmental, food safety, disease and laboratory diagnostics. Scienion is a life science company in the markets of dispensing systems and microarray scienion.de technologies. The product portfolio comprises hardware, consumables and services. Scienion s leading product is the sciflexarrayer dispensing system, available in a product line of six size versions. The dispenser allows the aspiration of ultra low liquid volumes from different reservoirs and non-contact micro drop delivery in the picoliter to microliter range onto a variety of carriers. Production, development and sales of automated HPLC machines for high-throughput purification and fractioning of complex substance compounds. sepiatec.com Seramun offers peptide synthesis, purification and conjugation of proteins, production of seramun.com antibodies, customer research, in vitro-diagnostics. We focus on the development and production of enzyme immunoassays for diagnosis of viral and bacterial infections and autoimmune diseases of the gastrointestinal tract, the development of multi-parameter assays as microtitre plate assays and as membrane immunoassays, as well as development of ready-to-use substrate solutions and for protein stabilizers. Analytical laboratory services and consulting for development, production and quality control of drugs. institut-fresenius.de Development, production and purification of monoclonal antibodies for use in diagnostics. sifin.de Development and production of blood grouping reagents, Serafol bedside cards and test reagents for serotyping of Salmonellae, Shigellae, E. coli and Yersiniae. Development and production of culture media for microbiological diagnosis. Signature Diagnostics is dedicated to the discovery, validation and commercial development of novel diagnostic products that predict outcome and drug response in patients with signature-diagnostics.de colorectal cancer (CRC), non-small cell lung cancer (NSCLC) and ovarian cancer. Signature believes that patient selection and stratification based on molecular gene signatures will soon become an important component of routine cancer treatment. 73

74 BioTOP-Report Biotech Companies Silence Therapeutics AG SINA Science Services GmbH SLM- Speziallabor für angewandte Mikrobiologie GmbH STRATEC Molecular GmbH Strix Diagnostics GmbH Surflay Nanotec GmbH t-cell Europe GmbH Thanares GmbH Silence Therapeutics AG is a leading RNAi therapeutics development company and offers a silence-therapeutics.com novel, proprietary sirna technology (AtuRNAi) and proprietary systemic delivery systems for sirna (AtuPLEX, DACC and DBTC). SILENCE pipeline consists of both partnered and internal programs of which 3 clinical phase II and 1 clinical phase I programs are partnered with Pfizer/Quark (2 ophthalmic indications) and Novartis/Quark (2 kidney indications). Silence?s internal lead compound Atu027 is currently in a Phase I clinical study for the treatment of solid tumours. SINA is a modern company providing elaborate services in molecular biology and protein sina-science-services.de biochemistry. Together with our industrial partners and customers from research institutions we develop complex cloning and mutagenesis strategies including high-throughput applications. We offer cloning of genes, expression and purification of proteins, DNA and RNA isolation from numerous biological materials and the production of competent cells with high transformation efficiency. Microbiological quality control for medical devices, pharmaceuticals, cosmetics, drinking speziallabor.com water, foodstuff, monitoring in clean rooms. STRATEC Molecular GmbH is a globally active provider of innovative system solutions for invitek.de nucleic acid sample collection, stabilization, and both manual and automated purification from any sample type. Since 1992 the company is internationally respected for its outstanding and high performance technology platforms and offers a broad spectrum of superior products for molecular diagnostics, drug discovery and Life Science research. Strix Diagnostics is a medical diagnostics company specializing in customized development of certified analytical systems for multiparameter in vitro-diagnostics. strix-diagnostics.de Surflay Nanotec GmbH, a spin-off company from Capsulution NanoScience AG, is specialized on coating colloidal and planar materials with functional films. Key technology is the surflay.com patented LbL-Technology with polymers. Applications are in the fields of separation materials, pigment encapsulation, bio-sensing and diagnostic particles. In addition to customer tailored projects Surflay offers an unique range of products of tunable multifunctional nano-or microparticles and dye-labeled polymers. t-cell Europe GmbH, a spin-off of the Berlin Brandenburg Center for Regenerative Medicines (BCRT), is aiming to become the world s technology leader in the application of T-cell- t-cell.de based therapies used in transplantation medicine. Over the next few years, with its three proprietary platform technologies, the company will develop and clinically validate novel T-cell-based products and corresponding diagnostics to regulate the immune system and treat viral infections. The company s lead reference product will be a first-in-class Treg cell product/therapy for kidney transplantation that suppresses organ rejection in recipients Development, use and marketing of analytical process for diagnostic and therapeutic purposes. Future business activities: detection process for bioactive substances in bodily fluids, thanares.com isolation, characterization and investigation of bioactive compounds from plants, in particular insoluble proteins or low concentrations of proteins, development of low cost genetic systems for over-expression and/or production of such proteins. TheraKine BioDelivery GmbH Development of antibody drug delivery systems and related tasks. therakine.com Thermo Fisher Scientific B R A H M S GmbH TIB MOLBIOL Syntheselabor GmbH TissUse GmbH TransTissue Technologies GmbH UGA Biopharma GmbH Thermo Scientific Biomarkers (B R A H M S GmbH) explores, develops and produces new diagnostic test procedures to improve the diagnosis, and thereby the treatment, of life-threatening illnesses. This takes place with over 470 employees, in the disease areas infectiology, cardiology and pneumology as well as thyroid, autoimmunity and cardiology on the basis of our own patented biomarkers. Since October 2009 B R A H M S GmbH is part of Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science. thermoscientific.com/ brahms In 1990, TIB MOLBIOL became the first German manufacturer of oligonucleotides. In addition to designing and synthesizing primers and probes for Real-Time PCR assays, we tib-molbiol.com develop and produce LightMix Kits for Roche Diagnostics LightCycler Instruments, covering applications in Clinical Chemistry, Pharmacogenetics, Pathogen Detection, as well as Cancer Research. TIB MOLBIOL is ISO and ISO 9001 certified. TissUse is a vibrant growth company providing high-value services in the area of tissue tissuse.com culture analysis of drug candidates, cosmetics, chemicals and consumer products. TransTissue has been a subsidiary of BioTissue Technologies, Freiburg since September transtissue.com With more than 15 years of experience in regenerative medicine, the scientists of TransTissue Technologies have developed second-generation autologous tissue replacements, e.g. cartilage and bone grafts. We are mainly concerned with inventions and the development of tissue engineering products for regenerative medicine. We offer a broad panel of services in the field of regenerative medicine. UGA Biopharma a private Research and Development company, focuses on Research, Development and Commercialization of Biopharmaceutical products under contract with ugabiopharma.com other Biopharmaceutical companies. UGA Biopharma conducts power of biosciences to develop high-tech, last generation of biomedicine, diagnostic kits, molecular biology items and also offers world class services in biotechnology area. 74

75 BioTOP-Report Biotech Companies Umwelttechnik Dr. Bartetzko GmbH VasoTissue Technologies GmbH Zellwerk GmbH Zentrum für molekulare Onkologie GmbH Zytomed Systems GmbH Feasibility studies, development, planning, construction and operation of biotechnological bartetzko.com plants for groundwater, process water and waste water purification. Accredited microbiological laboratory for the investigation of drinking water, groundwater, bath water, soils, food, anti-microbial active ingredients and sterility according to Ph.Eur, approved in accordance with BiostoffV and the German infection protection act (Infektionsschutzgesetz). The company is active in the field of product development for advanced medical therapies. For its first product - the endothelialised vascular graft ( VasoGraft )- VasoTissue obtained a manufacturing license in Currently, VasoTissue s focus is on conducting its first clinical trial. vasotissue.de Zellwerk produces the proprietary Z RP cell cultivation system, comprising rotating bed zellwerk.biz bioreactor, GMP Breeder, Control Unit, software. Bioreactors with ml volume, 0,2-2 m² seeding surface, different cell carriers, can be delivered. In this culturing system cells grow tissue-like, being embedded in self-generated extra-cellular matrix. The technology opens unique opportunities for the GMP-compliant expansion of stem cells and primary cells, manufacturing of cell-seeded implants as well as production of recombinant proteins. In addition, we have recently developed a new bioreactor for expansion of immune cells for cell therapy of leukemia and several types of cancer. Innovative methods for diagnostic and therapy of tumor diseases - Molecular genetics molekulare-onkologie.eu (K-RAS, PCA3, Septin9,...) - Chemoresistance assay for prediction of chemotherapy - Pathology Development of new biomarkers and analytical services for studies. Zytomed Systems focus is the development, production and distribution of antibodies zytomed-systems.de and detection systems for immunohistochemical cancer diagnostics as well as reagents and kits for in-situ hybridisation. 75

76 BioTOP is a joint initiative of the state of Berlin and the state of Brandenburg under the umbrella of the Berlin Partner für Wirtschaft und Technologie GmbH and takes part in the Cluster Management HealthCapital. BioTOP is funded by the federal state of Berlin, the federal state of Brandenburg and the Investitionsbank Berlin, co-funded by the European Union (European Fund for Regional Development). Investing in your Future