Fraunhofer%20Institut%20f

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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
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Summary
About the Fraunhofer Institute Opportunities in
the Czech Republic Opportunities for Fraunhofer
Possible Synergy
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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
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Die Fraunhofer-Gesellschaft
The Institute for Cell Therapy und Immunology
The Verbund Life Sciences
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.
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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

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Main Topics
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Research Immunology

• Research, development and pre-clinical evaluation
  (GLP)
• Integrated RD solutions supported by the
  existing technological infrastructure Contract
  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

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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

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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

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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

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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
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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
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Complementary cross-border cooperation
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 EU projects
• Cooperation in applied research
• Cooperation in development of intellectual
  property
• Cooperation in training young scientists for
  biotech careers

Cooperation in scientific projects
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Complementary cross-border cooperation
Czech Republic
Germany

• High growth potential
• Highly educated labor force
• Growing Biotech sector
• Growing clinical trial area

EU project potential Expertise in applied
research, IP commercialization Existing Biotech
Infrastructure Experience in regulatory affairs,
GMP, GLP and GCP
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Nano4Nerves
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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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Vielen Dank für Ihre Aufmerksamkeit!