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2014
Journal Article
Titel
Translational research initiatives in Germany
Titel Supplements
Experiences on cell processing services
Abstract
The Fraunhofer Institute for Cell Therapy and Immunology IZI is part of the Fraunhofer-Gesellschaft (FhG). FhG was founded in 1949 and is one of the "big four" German non-University research organizations, and is the largest society for applied research in Europe. Fraunhofer-Gesellschaft operates 66 institutes and independent research centres in Germany. It has more than 22,000 employees and an annual budget above 1.9 billion Euro. The Fraunhofer Institute for Cell Therapy and Immunology was founded in April 2005 and is located in Leipzig (headquarters), Halle and Rostock in the eastern part of Germany. Fraunhofer IZI's objective is to find solutions to specific problems at the interfaces between medicine, life sciences and engineering for partners active in medicine-related industries and businesses. Currently it has more than 230 highly qualified staff members and is divided in five independent scientific departments: a.) Cell Engineering; b.) Immunology; c.) Cell Therapy; d.) Diagnostics and e.) Drug Design and Target Validation. The Department of Cell Engineering consists of the Cell Engineering GLP Unit and the Cell Engineering GMP Unit. Preclinical Good Laboratory Practice (GLP) - studies for cell-based medicinal products in small and large animal models are the main focus of the Cell Engineering GLP Unit. The Cell Engineering GMP Unit operates with more than 60 employees two state of the art clean room facilities for aseptic manufacturing according to Good Manufacturing Practice (GMP). The facilities are designed for manufacturing and quality control of autologous or allogeneic cell-based therapeutics so-called Advanced Therapy Medicinal Products - ATMP's (e.g. tissue engineering products, somatic cell therapeutics, gene therapeutics) for clinical trials. A comprehensive quality assurance system covering the nine chapters of the EU Guidelines to Good Manufacturing Practice is the framework for all manufacturing and quality control activities. It consists of more than 750 documents and to date has been successfully inspected eight times by the Germany pharmaceutical authorities. The Cell Engineering GMP unit offers the following services to clients: a.) contract manufacturing and quality control; b.) support in set-up and validation of GMP-compliant manufacturing processes and quality control assays (process development); c.) application for product specific manufacturing authorizations according to section 13 German Drug Act; d.) application for tissue procurement permissions according to section 20b German Drug Act; e.) application for import permissions from countries outside of the European Union (e.g. for human derived materials used for manufacturing); f.) support in regard to Investigational Medicinal Product Dossier (IMPD) writing and g.) regulatory consultancy. The clients that perform their clinical trials together with Fraunhofer IZI's Cell Engineering GMP Unit are mainly biotechnology companies from all over the world, e.g. from USA or Australia. Manufactured products range from Dendritic Cell based immunotherapies up to stem cell based products. A wide variety of clinical trials up to phase III pivotal studies are within the current project spectrum. The annual revenue of the Cell Engineering GMP Unit in 2013 was 2,850,000 Euro. This was sufficient to cover all running costs and to generate a slight positive cash flow that is used as a backup if required. In addition to the given information in regard to infrastructure, services, clients and budget this presentation will provide specific information about methods to recruit talented human resources and to reach and maintain a sustainable business model in the cell therapy manufacturing area.