Fraunhofer Institute for Cell Therapy and Immunology
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: | |
|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: | |
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