The Fraunhofer Institute für Cell Therapy und Immunology
Applied Research in Leipzig
Sonya Faber
Fraunhofer Institut für Zelltherapie und ImmunologieJoint Workshop of the BMBF and the MSMT
Prague, 7th of December, 2006
Bridging the gap between the Czech Republic and Germany in the Life Science sector
About the Fraunhofer Institute
Opportunities in the Czech Republic
Opportunities for Fraunhofer
Possible Synergy
Summary
Mission
Applied research to support industry the service sector and the government
Research
Innovative research for public and commercial interests annual research budget of 1 billion euro
Cooperation Partners/Clients
Industry and Service Providers Government
The Fraunhofer Society
Researcher
Inventor
Entrepreneur
Joseph von Fraunhofer(1787 - 1826)
Die Fraunhofer-Gesellschaft
56 Institutes
about 80 Research units
Karlsruhe
DarmstadtWürzburg
Jena
Stuttgart
Duisburg
Oberhausen
Nuthetal
Dortmund
Oberpfaffenhofen
München
Saarbrücken
St. Ingbert
Erfurt
Magdeburg
Halle
DresdenLeipzig
Ilmenau
Cottbus
Braunschweig
BerlinPotsdam
Teltow
Aachen
Schmallenberg
Sankt Augustin
ErlangenFürth
Nürnberg
Freising
Holzkirchen
Pfinztal
Freiburg
Efringen-Kirchen
RostockItzehoe
Hannover
Bremen
Euskirchen Chemnitz
WertheimKaiserslautern
Schkopau
PaderbornIZI: Leipzig
5
The Institute for Cell Therapy und ImmunologyThe „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
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.
• 200 Staff Members
• 1600 m2 Laboratory area
• 450 m2 GMP area
• 1600 m2 Office area
• 24 Mio. Euro
• Completion: Spring 2008
The Institute for Cell Therapie and Immunology
Abb.1
Animal Models Transplantation
ImmunomodulationTissue Embedding Immunotolerance
Bioreactors and Bioprocesses
Immun- and Cell Diagnostics
CytokinesTissue and
Organ Culture
Cell TherapyStem Cell Platforms
Regeneration Technology
Zelle
Main Topics
Research, development and pre-clinical evaluation (GLP)
Integrated R&D 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
Research: Immunology
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
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
GLP GMP GCP
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, 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 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
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
Complementary cross-border cooperation
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
Czech Republic Germany
Nano4Nerves
Project Service Team
Head: Dr. Wilhelm Gerdes
Business Development
Public Relations
Investment and Grant Funding
Patent- & Licence consultation
Project Management
Strategic Planning
Forschung: Service
Vielen Dank für Ihre Aufmerksamkeit!