The Fraunhofer Institute für Cell Therapy und Immunology

1. 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, 7th of December, 2006

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

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

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

5. The Institute for Cell Therapie and Immunology • 200 Staff Members • 1600 m2 Laboratory area • 450 m2 GMP area • 1600 m2 Office area • 24 Mio. Euro • Completion: Spring 2008

6. 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 Main Topics

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

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

9. GLP GMP GCP Service • 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

10. 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

11. 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

12. 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

13. 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 6th 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

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

15. Nano4Nerves

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

17. Vielen Dank für Ihre Aufmerksamkeit!