Telstar leads the international Life Sciences Engineering business of the azbil Group

Transcription

1 . May 2013 Number 24 CORPORATE Telstar leads the international Life Sciences Engineering business of the azbil Group Azbil Group is a leading company in Building Automation, Advanced Automation and Life Automation for Healthcare and other markets connected closely to everyday life Telstar, as part of azbil Group, is leading the launching of a new business Life Science Engineering Telstar has expanded its business in the Life Sciences field to provide new solutions related to manufacturing equipment with environmental systems and automation technologies for the markets contributing to people's health. This decision was made following the agreement reached by Japanese Azbil to acquire 80% of Telstar SA from the founding shareholders in December Azbil is a leading Japanese group in building automation for the building market, advanced automation for the industry market and life automation systems for the life sciences and healthcare markets as well as fields connected closely to everyday life. The group develops its own regulation, control and automation technologies, equipment and systems used in industry and in buildings. Azbil Group, which is listed on the Tokyo stock exchange, was founded in 1906 and currently has a workforce of 5,185 people and a revenue of $2,725.6M in year 2012 (FY 30/3/2012). As a subsidiary of Azbil, Telstar leads the Life Science Engineering business division of the Japanese corporation to provide global solutions in design, engineering and manufacturing processes with automation technologies for the international life science markets, such as biopharmaceutical, life science research, regenerative medicine and functional foods. In this context, Azbil plans to introduce products, services and solutions in fields with great potential with future growth, such as biopharmaceutical, life science research, personalized medicine for medication and treatment customization based on individual patients' treatment plans, and regenerative medicine represented today by technologies such as the ips cell (induced pluripotent stem cell), and expand to the global market in the near future. Through this partnership, Azbil has strengthened its overseas sales operations by utilizing Telstar's sales network established in the pharmaceutical, laboratory and hospital sectors in Europe, Latin America, and North America, while Telstar will expand its business domain through Azbil's operating bases in the Asian region, as well as strengthen its solution-providing capabilities by applying Azbil's technologies to new product development and system integration. Based on the principles and values of Azbil, the technological and operating synergies and the complementary geographic network of sales between Azbil and Telstar, the Spanish company has identified in Azbil a strategic business partner to continue driving the business forward. By providing product and services created through the synergy of the two companies, Azbil and Telstar aim to deliver superior customer value. Telstar retains its headquarter in Terrassa (Barcelona) to develop its activities in Life Science Engineering, which will continue to operate under the Telstar brand. Editorial. Telstar consolidates global supply position Telstar Group. Telstar completes its web site with the addition of project services information for the Life Science market Exhibitions and Conferences BACK COVER Life Science Solutions LABORATORY. Telstar develops a containment unit for use in biomedical research at the Institute of Materials Science of Barcelona, part of CSIC PHARMA. Telstar develops three integrated lines for bulk production of potent sterile antibiotics for Hisun Pharmaceutical. Square Pharmaceuticals contracts Telstar for the entire deveopment of new pharmaceutical plants for production of oral and parenteral products. Telstar reinforces its pharmaceutical consulting area by adding a new line of consulting and deployment services for quality by design (QbD) systems Vacuum Solutions. Telstar provides a simulation chamber for vacuum thermal tests on micro-satellites

2 EDITORIAL Telstar consolidates global supply position Two years after the integration of Telstar's activity under a single brand, the company has consolidated its position as an international supplier of global high-tech solutions for the industry linked with the life science market, especially in Europe, America and Asia. With 50 years of experience, Telstar is now recognised as one of the ten major international suppliers of global solutions for the biopharmaceutical industry and the only international specialized company with the ability to offer complete solutions in engineering, construction, process equipment design and manufacture, equipment and critical systems installation and services (commissioning and qualification, staff training and quality assurance) for turnkey bio technical and pharmaceutical plants with its own technologies, subject matter experts and resources. Telstar, which has seven production plants and nine technology centers worldwide, invests 3% of its turnover in R&D+i. The company is currently constructing two new pharmaceutical plants for the international Bengali company Square Pharmaceuticals and three integrated high potent lines for sterile antibiotics for the Chinese P h a r m a c e u t i c a l C o m p a n y H i s u n Pharmaceutical. CORPORATE Telstar completes its web site with the addition of project services information for the Life Sciences market Telstar integrates into its web site the Project Services of consultancy, engineering, construction and IT solutions, to better reflect the complete portfolio of the global solutions offered by the company Through the recent inclusion of detailed information of project services in the fields of consultancy, engineering, construction and IT solutions, Telstar's web site now contains information on all of its Life Sciences product and services. In the Life Sciences field, the Telstar web site is now organized to reflect and reinforce its position as a supplier of global integrated solutions. The website visual structure provides a rapid access to two main groups Technology Equipment and Project Services- to simplify user-access to the information. Also, the structure of the site enables market oriented access to the information; Pharmaceutical Industry, Laboratory and Hospital. The uniqueness of Telstar lies in its capacity to offer complete global solutions in consultancy, engineering, construction and IT solutions, and also integrated process equipment solutions developed using its inhouse technologies, for pharmaceutical applications. In essence the Telstar web site is constantly evolving in response to the nature of its business and the markets it serves. The updating process of the website has also provided the opportunity to incorporate social networks and give greater emphasis to multimedia resources.

3 VACUUM SOLUTIONS New! Telstar provides a simulation chamber for vacuum thermal tests on micro-satellites -7 The chamber can reach a vacuum level of 10 mbar and the temperature range extends from -180 C to +180 C Telstar has developed and supplied a space simulation chamber for Instituto Universitario de Microgravedad Ignacio da Riva, in Universidad Politécnica de Madrid. Featuring a test chamber 1.0 meters in diameter and 1.4 meters in length, this system is intended for space simulation tests and behavior analysis of microsatellites and other space equipment, under thermal and vacuum conditions which simulate the actual conditions present in space. The system can be used for qualification tests (using qualification models not intended for launch) and for acceptance tests (using models that will be launched into space). The chamber can reach a vacuum level of 10-7 mbar, which is equivalent to one- 10,000-millionth of an atmosphere. The temperature range extends from -180 C to +180 C. These conditions expose space systems and equipment to stress levels similar to those that will be found in space, where the satellite is exposed to solar radiation without atmospheric protection, and to an extremely cold environment when shadowed by the Earth. LIFE SCIENCE SOLUTIONS - Laboratory Telstar develops a containment unit for use in biomedical research at the CSIC, Institute of Materials Science of Barcelona Telstar has developed and supplied a containment unit for the Institute of Materials Science of Barcelona (ICMAB), which belongs to the National Research Council (CSIC) that will be used for the preparation of micro and nanoparticulate materials and nanomedicines used in biomedical research. The unit is a four glove dispensing isolator; the first of its kind at the institute, which will be used by Nanomol research group, from ICMAB. The system utilises standard Isolator design features for ventilation, visor panels, safe-change gauntlets and filtration and is integrated with a custom control system, including Siemens PLC and HMI touch screen, to provide the level of operator interface expected in today's technological arena. Pressure and air monitoring instruments are linked via PLC to the main air controls, to maintain appropriate air quality during operation. In addition, wash-gun features facilitate thorough clean down between products. The unit will achieve operator exposure levels of <0.1µg/m³, which will enable highly active and hazardous products to be processed. The isolator developed by Telstar provides the full capability to handle the technology developed by Nanomol over the past few years, and enables nanoprocessing of cytotoxic molecules, such as the one developed under ORALBEADS collaborative project funded by the program INNPACTO 2011 MINECO (Spanish Ministry of Economy and Competitiveness). This project is coordinated by the Spanish company Pharmamar, a leader in the development of antitumor drugs of marine origin.

4 LIFE SCIENCE SOLUTIONS - Pharma Telstar develops three integrated lines for bulk production of potent sterile antibiotics for Hisun Pharmaceutical LIFE SCIENCE SOLUTIONS - Pharma Chinese firm Zhejiang Hisun Pharmaceutical Co. Ltd. is a major international manufacturer of APIs (Active Pharmaceutical Ingredients) This is the largest integrated project using proprietary dosing, freeze-drying, sterilisation, unloading and packing technologies. Telstar has successfully developed three integrated production lines incorporating proprietary dosing, freeze-drying, unloading and end packing technologies for the manufacture of bulk sterile antibiotics for Hisun, one of the largest Chinese producers of APIs (Active Pharmaceutical Ingredients). This is the largest integrated project to be carried out in China in which a single company, Telstar, provided all of the technology for the entire primary packaging process. The integrated freeze-drying system features an automatic loading and unloading system operating under sterile conditions within a production isolator. Specifically designed for the freeze-drying of antibiotics, the system incorporates a sterile isolator which protects the operator and provides an ISO 5 class manufacturing environment. Production operations are carried out by automation systems inside the isolator so the risk of contamination during human manipulation of the product is eliminated, while the operators are also protected from the potency of the product. The first stage of the process (freeze-drying) is composed of three GMP production freeze-dryers and automatic tray loading and unloading systems installed inside sterile isolators, together with equipment to dispense the liquid product into trays. After the freeze drying cycle is complete, vacuum unloading systems move the freeze-dried product into IBC containers. The project also includes steam autoclaves and various RAB (Restricted Access Barrier) and isolator systems necessary for other applications associated with the production process. The second stage of the process involves weighing and packing support for each of the freeze-drying systems. An integrated autoclave is used to steam-sterilize aluminium canisters, which are then dosed from the IBC with a weighed quantity of the freeze-dried product. Packing then completes the process, all of which will operate within an isolator to guarantee operator safety and ISO 5 classification. Telstar has supplied this complete system in triplicate, thereby giving the client greater flexibility in carrying out large-volume production. Also designed into the system is the possibility to expand the production in the future by incorporating new freeze dryers and sharing much of the existing equipment. Telstar's capability to develop and manufacture this system entirely in-house provides the client with a cost-effective solution and assures quality control over the whole process. LIFE SCIENCE SOLUTIONS - Services Square Pharmaceuticals contracts Telstar for the development of new plants for production of oral and parenteral products Bangladesh's largest pharmaceutical company consolidates its leadership in the Asian continent Telstar is managing the full execution of two new pharmaceutical plants for the international Bengali company Square Pharmaceuticals. For the first project, Telstar is managing the construction of a plant for the production of oral solids consisting of a 2 four-story building of 32,000 m with 7 fluidized bed granulation lines, 11 tablet lines, 4 lines for capsules, and 16 primary and secondary packaging lines, plus a second 2 service building of 1,000 m. The second project consists of a 20,000 m 2 four-story building for production of parenterals in small and large volume formats, including two lines for manufacturing BFS bottles with two reactors of 20,000 litres each, a line for manufacturing glass bottles, one for bags, two for vials, two for preloaded syringes, one for lyophilized vials with two freeze-dryers and one topical aerosol production line. Telstar performed the engineering for both plants and was the winning bidder for the full project administration and provision of the pharmaceutical architecture and the process equipment and critical installations; managing the coordination of local installers for the remaining installations. Square Pharmaceutical's trust in Telstar as a technological partner is based on its knowhow, experience and capability in the development of these types of large scope projects. Since 2003, Telstar has collaborated with Square on a number of high-complexity projects which involved the development of production installations and plants. Outstanding examples include the new cephalosporin plant built in 2005, the new plant for sterile filling and bottling of pharmaceutical liquids with Blow-Fill-Seal (BFS) technology in 2007, the new insulin production plant in 2010 (with the ability to produce up to 13 million vials of insulin per year) and, finally, the SVPO plant for production of small volume parenterals and ophthalmology products inaugurated in 2008 in Dhaka. Square Pharmaceuticals Limited is the largest manufacturer of pharmaceutical products in Bangladesh. The most prominent company of the Square Group since its founding in 1958, it has experienced solid growth leading it to its current leadership position in its country and in the Asian continent. With a market share of 18.71%, Square Pharmaceuticals obtained a sales volume of approximately 212 million dollars in 2011.

5 LIFE SCIENCE SOLUTIONS - Services LIFE SCIENCE SOLUTIONS - Services Telstar reinforces its pharmaceutical consulting area by adding a new line of consulting and deployment services for quality by design (QbD) systems Having completed the acquisition process of dtc Development Team Consulting, Telstar strengthens its ability to develop quality systems in GXP environments The company has also enhanced its consulting and deployment service for R&D and pharmacovigilance quality systems Telstar consolidates its standing as the only company capable of offering a global and comprehensive pharmaceutical consulting service Telstar has reinforced its pharmaceutical consulting area by driving two new business lines that will offer consulting services for quality systems in GXP environments. Specifically, Telstar has incorporated a new Quality by Design (QbD) deployment service, and has expanded its R&D quality systems service for the preclinical (GLP) and clinical (GCP) phases in the development of active ingredients and drugs, as well as for pharmacovigilance in the marketing phase. The expansion of Telstar's consulting services portfolio took place on February 1, 2013, when the Catalonian company acquired dtc Development Team Consulting's business. dtc Development Team Consulting, which has been in business since 2000, is highly specialized in executing projects that deal with GXP regulatory compliance and with the improvement of manufacturing processes based on Quality by Design concepts. With the integration of dtc's know-how into its business, Telstar now stands strengthened as the only Spanish company capable of offering a global pharmaceutical consulting service that encompasses the entire drug life cycle. Quality by Design in product development, manufacturing and marketing of drugs and API's is a win-win strategy oriented toward achieving robust and efficient processes, which leads to a quality assurance for the product with costs optimization. Efficiency in manufacturing processes reduces inspection efforts and product related non-quality costs. It is a highly competitive methodology when compared with the traditional quality assurance system based primarily on final inspection and control, which is clearly less efficient. The regulatory framework to work in QbD is firmly established, and the latest GMP updates require adapting quality systems to the new, risk management-based models, and adapting production systems to permit continuous process monitoring and verification. In fact, and as of January 2013, the US FDA requires the use of QbD methodology for the drug marketing authorization process of generic products. The integration of this specialized service enables Telstar to position itself as a leading provider of GLP services for nonclinical development, GCP services for clinical development, QbD services for process development and redesign, PAT/NIR services for process monitoring and control and GMP services for GMP production and operational excellence. The full range of Telstar's consultation services has now been consummated by the incorporation of these two business lines, with services related to Regulatory Affairs and Compliance in the life sciences sector.

6 EXHIBITIONS AND CONFERENCES Laborama Groot-Bijgaarden(Holland) Medtec Stuttgart (Germany) PharmTech, Moscú (Russia) Pharma Congress Düsseldorf (Germany) 22nd Annual Vendro Night, San Francisco (USA) ISPE Critical Utilities, Florida (USA) Interphex NYC, Nueva York (USA) ISPE Annual Meeting, Washington (USA) CGMP Conference, Baltimore (USA) Forum Labo & Biotech Paris (France) A3P Pau(France) Farmamaq Zaragoza (Spain) AEFI, Barcelona (Spain) era, Rome (Italy) ArabLab, Dubai (UAE) Asian Pharma Expo, Dhaka (Bangladesh) ISPE Annual Conference, Beijing (China) CIPM, Qingdao (China) Analytica Vietnam, Ho Chi Minh (Vietnam) ISL-FD, Sao Paulo (Brazil) Farmamaq: 13 February, Zaragoza (Spain) Asian Pharma Expo: February, Dhaka (Bangladesh) ISPE Critical Utilitites: February, Tampa (USA) Medtec: February, Stuttgart (Germany) Arablab: March, Dubai (UAE) 22nd Annual Vendor Night: 14 March, Baltimore (USA) Laborama: March, Groot-Bijgaarden (Holland) Laborama: March, Groot-Bijgaarden (Holland) Pharma Congress: March, Düsseldorf (Germany) A3P: 3 April, Pau (France) era: April, Rome (Italy) Analytica Vietnam: April, Ho Chi Min City (Vietnam) ISPE China Annual Conference: April, Beijing (China) Interphex NY: April, New York (USA) CIPM: April, Qingdao (China) Coming Exhibitions May 2013 June 2013 July 2013 L M M J V S D AEFI, Barcelona (Spain) L M M J V S D Forum Labo & Biotech, Paris (France) CGMP Conference, Baltimore (USA) L M M J V S D Pharma Congress, Düsseldorf (Germany) ISPE Critical Utilities, Tampa (USA) ArabLab, Dubai (UAE) Edited by: TELSTAR TECHNOLOGIES, S.L. Photographs: TELSTAR TECHNOLOGIES, S.L National Book Catalogue Number: B TELSTAR TECHNOLOGIES, S.L. Av/ Font i Sagué, Terrassa (España) T F [email protected]