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. |

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|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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