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ePaper created 2013-09-24, 11:56:35 | version 1.25.20
Prof. Dr. Heike Walles Head of Department of Cell and Tissue Engineering Phone +49 711 970-4117 heike.walles@igb.fraunhofer.de Contact human organism, with the consequence that a large number of animal experiments could be replaced. Another goal is the use of our complex tissues as transplants in regenerative medicine. In our GMP manufacturing unit, we offer process development and manufacturing of autologous transplants (advanced therapy medicinal products, ATMPs) as investigational medicinal products (IMPs). The first step in- volves establishing and verifying the specific manufacturing process for a particular ATMP, which is then adapted to regu- latory demands. The final step is applying for the manufactur- ing authorization for investigational medicinal products. At present, we possess manufacturing authorization for an auto- logous cartilage transplant, an autologous stem cell transplant and an autologous blood vessel transplant for bypass surgery. Range of services Cell culture technology of primary human cells and of spe- cific cell culture media In vitro testing of biocompatibility according to DIN ISO 10993-5 Cell biology analysis Molecular-biological, histological and immunohistologi- cal methods Flow cytometry (FACS), including cell sorting Modern digital image processing techniques such as mi- crodissection and Raman spectroscopy Establishing of various 3D tissue models Accredited for REACH testing Alternatives to animal testing in cosmetics R&D ADMET testing in substance and drug screening Target screening for new therapeutics and infection bi- ology Development of specific computer-controlled bioreactor systems for the cultivation of vascularized tissue models Process development, manufacturing and testing of cell and gene therapeutics as investigational medicinal prod- ucts or ATMPs (phase I/II clinical studies) Infrastructure and technical equipment Cell culture laboratories conforming to safety levels S1 and S2 of the German GenTSV (genetic engineering safety reg- ulations) State-of-the-art equipment like inverse fluorescence micro- scope, FACS, and microdissection instrumentation GMP production unit (cleanrooms, separate quality control area, storage facilities) 51