TRANSLATING VISIONS INTO SOLUTIONS

Transcription

1 TRANSLATING VISIONS INTO SOLUTIONS

2 MORE THAN A PARTNERSHIP STRATEC: AN INNOVATIVE PARTNER STRATEC has been a reliable, predictable and innovative partner for more than 35 years to established market leaders and dynamic market changers companies committed to delivering products that make a difference for their customers. STRATEC offers more than engineering skills around the automation of hardware and software solutions STRATEC understands your ideas and offers a solution from the first idea, through the development and approval process, to manufacturing your final product. 2 3

3 LTD Markets Regulated Markets MARKETS Life Sciences Industrial Markets In vitro Diagnostics stratec biomedical

4 PROVEN EXPERTISE 35 YEARS OF DELIVERING SOLUTIONS AND TECHNOLOGIES STRATEC translates the ideas of partners into concepts and specifications that become high quality solutions and approved products used in laboratories and research institutions worldwide. Requirements and Specifications: Together we translate your ideas and requirements into specifications and a concept with a clear timeline and a defined budget right from the start. Molecular Diagnostics: We offer broad sample management expertise using innovative and customizable solutions for nucleic acid sample collection, stabilization and purification. Instrumentation: Our highly reliable automated workflows and technologies are designed to fulfill regulatory requirements in all markets. We meet your customers needs by developing innovative customized hardware and software solutions and using modular technologies. Laboratory Software: We provide customized data management solutions and approved off the shelf products to fit your product offering and integrate your solutions into the laboratory workflow of your customers. Regulatory Compliance: Our regulatory compliant processes with state-of-the-art systems deliver comprehensive documentation to facilitate smooth approval processes in relevant markets. Quality Management: Our certified Quality Management System guarantees audited development and manufacturing processes, alongside established complaint handling, change control and proven risk management. 4 5

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6 PARTNERS ANALYZER SYSTEMS

7 Panther TM Gen-Probe 2 Dx Prep System Bio-Rad 3 LIAISON XL DiaSorin 4 Simoa HD-1 Analyzer Quanterix 5 NEO IMMUCOR GAMMA 6 InviGenius STRATEC Molecular 7 ETI-Max 3000 DiaSorin 8 ADVIA Centaur CP Siemens Healthcare Diagnostics 9 LIAISON DiaSorin 10 TANGO optimo Bio-Rad 11 Galileo IMMUCOR GAMMA 12 BEP 2000 Advance Siemens Healthcare Diagnostics 13 EVOLIS TM Bio-Rad 14 EUROIMMUN Analyzer I EUROIMMUN 15 ELISYS QUATTRO Human 16 EVOLIS TM Twin Plus Bio-Rad 17 DaVinci biomérieux stratec biomedical

8 DEVELOPING PARTNERSHIPS SPECIALIZED IN TAKING ON RESPONSIBILITIES AND DELIVERING ON THEM STRATEC s services and solutions allow our partners to focus on their core competence, control total cost of ownership, and leave responsibilities around instrumentation and automation to us. We offer a deep technology pool with a wide range of protected technologies and state-of-the-art process monitoring and safety features. Our customized solutions will cut development times and cost to a fraction compared to doing it from scratch. STRATEC supports you with clearly defined processes, from initial product conceptualization through the entire lifecycle, including development, manufacturing and beyond. We understand that time to market and freedom to operate are crucial for you and your customers. Concepts: Requirements, consulting and feasibility studies to avoid potential risks at the very beginning. Technology Pool Processes Development: It takes more than engineering skills to develop hardware and software that transforms complex biochemical processes into simple user activities. Manufacturing: STRATEC s Global Lean Manufacturing at highly specialized and regularly audited production sites and the 3,000+ systems manufactured each year prove that we effectively apply our experience and skills to deliver high quality products. Support Manufacturing STRATEC LIFECYCLE MANAGEMENT Concepts Development Support: The handling of day-to-day requests and complaints, staying compliant in an ever changing regulatory environment and dealing with obsolescences through our highly refined change management systems is of ever growing importance. A dedicated product support team provides concurrent engineering as well as product enhancements throughout the lifecycle of your product. 8 9

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10 TECHNOLOGY HISTORY 1979 STRATEC is founded in Birkenfeld, Germany 1988 Reader for radioimmunoassays 1992 Fully automated RIA system 1993 Own pipetting and liquid handling components 1993 First random-access continues-loading instrument 1996 Systems using magnetic microparticles in immunoassay processing 1996 Cartrige system for reagent handling developed 1998 STRATEC becomes a stock corporation 1999 Immunohematology analyzer using image analysis 2000 Multiprobe high throughput ELISA system 2001 Robotic microplate handling systems for immunoassay and immunohematology 2001 Automatic loadable and vertical orientated centrifuge 2005 Manufacturing site for higher volume production in Beringen, Switzerland 2006 Software providing bidirectional remote access 2009 First fully automated random assay molecular system 2009 Integrated air-pipettor technology 2009 Usage of RFID tags to enhance reagent management capabilities 2010 Competence Centre for high precision opto mechanics in Newbury Park, USA 2012 Detection System for single-molecule application 2012 Development of STRATECs stackable cuvette 2013 Software for workflow management in a molecular laboratory 2014 License for sourcing in Taicang, China 2003 First fully automated sample prep system for molecular diagnostics 10 11

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12 WHERE WE ARE WORLDWIDE Germany STRATEC Biomedical AG Gewerbestr Birkenfeld Germany Phone: Fax: info@stratec.com STRATEC Molecular GmbH Robert-Rössle-Str Berlin Germany Phone: Fax: info.berlin@stratec.com Switzerland STRATEC Biomedical Switzerland AG Neuwiesenstr Beringen Switzerland Phone: Fax: info.beringen@stratec.com USA STRATEC Biomedical USA, Inc Old Conejo Road Newbury Park, CA USA Phone: Fax: info.newbury@stratec.com UK STRATEC Biomedical UK, Ltd. 1 Barberry Court, Callister Way Burton upon Trent DE14 2UE United Kingdom Phone: Fax: sales.burton@stratec.com Romania STRATEC Biomedical S.R.L. Str. Bisericii Ortodoxe nr Cluj-Napoca Romania Phone: Fax: officecluj@stratec.com China STRATEC Biomedical (Taicang) Co., Ltd. No. 60, Yangzhou Road Taicang, Jiangsu, P.R. China Postcode Phone: Fax:

13 KEY FIGURES AT A GLANCE Sales 1 in Million Employees (Annual Average) Analyzer Systems Delivered , , , , ,281 2,319 2,000 1, , , , , , The accounting methods used in the consolidated financial statements were amended in line with IAS 8 in the 2013 financial year. Reference is made in this respect to the information in Section A of the notes to the consolidated financial statements. The previous year's figures stated in this overview of key figures (2006 to 2012) have not been adjusted and are therefore only comparable to a limited extent with the figures stated for the 2013 financial year. stratec biomedical

14 COMMITTED TO QUALITY STRATEC SUCCEEDS WHEN ITS PARTNERS SUCCEED STRATEC is dedicated to maintaining high quality consistently. We are committed to continuously enhancing our quality process and to adapting our quality management to the ever-changing business, legal and regulatory environments. Clearly defined processes throughout the entire value chain from the beginning of development through to higher volume mass production play a pivotal role when it comes to securing a dominant position in the market. At the same time, our diligence in quality management ensures that the necessary regulations are adhered to at all times in order to capture new markets quickly and efficiently together with our partners. CERTIFICATIONS/REGISTRATIONS: ISO 9001 ISO ISO CMDCAS FDA registered (compliant to 21 CFR Part 820) CSA/UL registered 14 15

15 HOW CAN WE TRANSLATE YOUR VISION?

16 STRATEC Biomedical AG Gewerbestr Birkenfeld Germany Phone: Fax: e