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!