Fraunhofer Institute for Cell Therapy and Immunology
GMP compliant manufacturing of biologics like cell therapeutics, tissue
engineering products, stem cell therapeutics, cancer vaccines, gene
therapeutics, therapeutic monoclonal antibodies, recombinant glycoproteins
Contact person details
Name:
SCHMIEDEKNECHT , Gerno ( Ph.D.)
Name of
Organisation:
Fraunhofer Society
URL:
http://www.izi.fraunhofer.de/
E-mail:
Contact
Telephone:
+49-0341-35536410
Fax number:
+49-0341-35536109
Collaboration
Type: Company Expertise
Title: GMP compliant manufacturing of biologics like cell therapeutics, tissue
engineering products, stem cell therapeutics, cancer vaccines, gene therapeutics,
therapeutic monoclonal antibodies, recombinant glycoproteins
Participation: Type A
Type Details: The GMP - manufacturing group of the Fraunhofer Institute for Cell
Therapy and Immunology (IZI) offers it's project partners from pharmaceutical and
biotechnology companies, research institutes and universities a full service package
around the topic GMP - compliant manufacturing of biologics for clinical trials.
These services include:
GMP-manufacturing of autologous or allogeneic cell-based therapeutics (e.g. tissue
engineering products, adult stem cell based therapeutics, cancer vaccines, gene
therapeutics).
GMP-manufacturing of therapeutic recombinant glycoproteins and antibodies in small
batch size (for phase I or early phase II trials) using mammalian cell lines.
Support in set-up and validation of GMP-compliant manufacturing processes and
quality control procedures as well as in applying for a manufacturing authorisation
according to § 13 German Drug Act (Arzneimittelgesetz, AMG).
Transfer of projects from research & development to a GMP-compliant level (process
development).
Consultancy regarding set-up of a quality assurance system that adheres to the EC
Guide to Good Manufacturing Practice.
Renting of separate clean room suites with customer responsibility for all
manufacturing processes including own manufacturing authorisation according to
§13 AMG.
For these services mentioned above we provide a state of the art multi purpose clean
room facility of 450 square meters as well as a highly qualified interdisciplinary
team.
Please contact:
Fraunhofer Institute for Cell Therapy and Immunology (IZI)
Dr. Gerno Schmiedeknecht
Deutscher Platz 5e
D-04103 Leipzig
phone: +49 (0)30 35536410
fax: +49 (0)30 35536109
Email: Contact
Programme: FP7 , FP7-KBBE , FP7-HEALTH
Instruments: CP Collaborative project (generic),LCP Large collaborative
project,MCP Medium size Collaborative project,SSCP Series of small collaborative
project(s)
Research interest:
Expiry Date: 2008-11-09
Workprogramme area(s)/key action(s):
Target Partner
Expertise:
We are seeking for partners, e.g. pharmaceutical or biotechnology
companies, research institutes that are interested in pharmaceutical development
and manufacturing of new active pharmaceutical ingredients and therapeutics of
biological origin and would like to seamlessly
segue into clinical trials.
Country:
World
Organization Details
Name:
Fraunhofer Society
Department:
GMP-facility
Address:
Leipzig
DEUTSCHLAND
Type:
Research
Number of
Employees:
250 500
Details:
Keywords:
GMP
cGMP
manufacturing
tissue engineering
cell therapy
monoclonal antibodies
glycoproteins
Partners already
acquired: