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The Fraunhofer Institute für Cell Therapy und Immunology Applied Research in Leipzig Bridging the The Fraunhofer Institute für Cell Therapy und Immunology Applied Research in Leipzig Bridging the gap between the Czech Republic and Germany in the Life Science sector Sonya Faber Fraunhofer Institut für Zelltherapie und Immunologie Joint Workshop of the BMBF and the MSMT Prague, 7 th of December, 2006

Summary About the Fraunhofer Institute Opportunities in the Czech Republic Opportunities for Fraunhofer Possible Summary About the Fraunhofer Institute Opportunities in the Czech Republic Opportunities for Fraunhofer Possible Synergy

The Fraunhofer Society Joseph von Fraunhofer (1787 - 1826) Researcher Mission Applied research to The Fraunhofer Society Joseph von Fraunhofer (1787 - 1826) Researcher Mission Applied research to support industry the service sector and the government Cooperation Partners/Clients Inventor n Industry and Service Providers n Government Research Entrepreneur Innovative research for public and commercial interests annual research budget of 1 billion euro

Die „Verbund Life Sciences“ The Fraunhofer-Gesellschaft The Institute for Cell Therapy und Immunology Business Die „Verbund Life Sciences“ The Fraunhofer-Gesellschaft The Institute for Cell Therapy und Immunology Business Areas: 56 Institutes Itzehoe Rostock about 80 Research units Accelerated drug development Bremen Regenerative Medicine Production and safety of food animal feed Biotechnical production, evaluation and testing of substances The Fraunhofer-Society is the leading organization for institutes of applied research in Europe, undertaking contract research on behalf of industry, the service sector and the government. Berlin Hannover Potsdam Teltow Braunschweig Nuthetal Magdeburg Paderborn Cottbus Oberhausen Dortmund IZI: Leipzig Halle Leipzig Schkopau Duisburg Schmallenberg Erfurt 5 Dresden Sankt Augustin Aachen Ilmenau Jena Euskirchen Chemnitz Darmstadt Würzburg Wertheim Erlangen Kaiserslautern St. Ingbert Fürth Nürnberg Saarbrücken Pfinztal Karlsruhe Stuttgart München Freising Freiburg Oberpfaffenhofen Holzkirchen Efringen. Kirchen

The Institute for Cell Therapie and Immunology • 200 Staff Members • 1600 m The Institute for Cell Therapie and Immunology • 200 Staff Members • 1600 m 2 Laboratory area • 450 m 2 GMP area • 1600 m 2 Office area • 24 Mio. Euro • Completion: Spring 2008

Main Topics Bioreactors and Bioprocesses Immun- and Cell Diagnostics Animal Models Transplantation Zelle Abb. Main Topics Bioreactors and Bioprocesses Immun- and Cell Diagnostics Animal Models Transplantation Zelle Abb. 1 Cytokines Tissue and Organ Culture Cell Therapy Stem Cell Platforms Regeneration Technology Immunomodulation Tissue Embedding Immunotolerance

Research: Immunology GLP GMP GCP 1. Research, development and pre-clinical evaluation (GLP) 2. Integrated Research: Immunology GLP GMP GCP 1. Research, development and pre-clinical evaluation (GLP) 2. Integrated R&D solutions supported by the existing technological infrastructure Contract research from concept to proof-of-principle 3. Development of therapeutic agents 4. Biosensor and biochip technologies 5. Preclinical evaluation of therapeutics for human and animal use 6. Full compliance with EU and FDA guidelines including good laboratory practice (GLP) 7. Development of diagnostic systems for pharmaceutical applications

Service GLP GMP GCP 1. Biopharmaceutical manufacturing (GMP) 2. Custom manufacturing of biologics under Service GLP GMP GCP 1. Biopharmaceutical manufacturing (GMP) 2. Custom manufacturing of biologics under GMP conditions for direct use in clinical trials 3. GMP-manufacturing of cell-based therapeutics, therapeutic recombinant proteins and antibodies 4. advice for buildup GMP-conform processes 5. Renting of clean room capacity including consent for customer-owned manufacturing permit 6. Practical support for GMP-compliant setup of manufacturing processes 7. Contract manufacturing

Service GLP GMP GCP Implementing novel therapies into the clinic (GCP) Close relationship with Service GLP GMP GCP Implementing novel therapies into the clinic (GCP) Close relationship with Leipzig University hospital permits access to walk-in-clinic infrastructure. In-house laboratories are similarly available for immunodiagnostic use. § § § Close cooperation with University clinic allows product testing in clinical trials (Phase I – II) Quality Management and GCP conform procedures Continuous service from trial design, through manufacture and approval

Czech Republic: Opportunity In 2005 63 biotechnology companies and 220 biotechnology research entities could Czech Republic: Opportunity In 2005 63 biotechnology companies and 220 biotechnology research entities could be found in the Czech Republic. Prague – biotechnology capital: 21 (32. 3 %) biotechnology companies and 101 (45. 9 %) research entities 22% of all biotech firms are environmental biotechnology 36% are plant biotechnology firms

Czech Republic: Highly Educated Population The Czech Republic has 78 universities and research institutes, Czech Republic: Highly Educated Population The Czech Republic has 78 universities and research institutes, with 7400 graduates per year in life sciences, which corresponds to about 18. 5% of all graduates

Cooperation: Fraunhofer Institute in Leipzig Generous public sector funding Total BMBF support for tissue Cooperation: Fraunhofer Institute in Leipzig Generous public sector funding Total BMBF support for tissue engineering 2004 - 30 mio Leipzig funding for Regenerative Medicine 2006 - 11 mio New connection between Leipzig and Prague - 2. 5 hours Unique Project Management Team structure to ensure project success Leipzig Prague

Complementary cross-border cooperation Cooperation in EU projects Cooperation in applied research Cooperation in development Complementary cross-border cooperation Cooperation in EU projects Cooperation in applied research Cooperation in development of intellectual property Cooperation in training young scientists for biotech careers Fraunhofer has more than 600 total EU projects in 6 th FP Fraunhofer has unique expertise in applied research Fraunhofer has experience and own patent office IZI expertise in regulatory affairs, GMP, GLP and GCP Cooperation in scientific projects

Complementary cross-border cooperation Czech Republic Germany High growth potential EU project potential Highly educated Complementary cross-border cooperation Czech Republic Germany High growth potential EU project potential Highly educated labor force Expertise in applied research, IP commercialization Growing Biotech sector Existing Biotech Infrastructure Growing clinical trial area Experience in regulatory affairs, GMP, GLP and GCP

Nano 4 Nerves Nano 4 Nerves

Forschung: Service Project Service Team Head: Dr. Wilhelm Gerdes Business Development Public Relations Investment Forschung: Service Project Service Team Head: Dr. Wilhelm Gerdes Business Development Public Relations Investment and Grant Funding Patent- & Licence consultation Project Management Strategic Planning

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