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ePaper created 2014-05-07, 13:23:14 | version 1.30.01
Prof. Dr. Petra Kluger Head of Department of Cell and Tissue Engineering Phone +49 711 970-4072 petra.kluger@igb.fraunhofer.de Prof. Dr. Katja Schenke-Layland Head of Department of Cell and Tissue Engineering Phone +49 711 970-4082 katja.schenke-layland@ igb.fraunhofer.de systems, we are able to test these properties in a more human situation than animal experiments, with the hope to eventu- ally replace animal tests, as required by the 3R’s initiative (re- placement, refinement, and reduction). 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 involves establishing and verifying the specific manufactur- ing process for a particular ATMP, which is then adapted to regulatory demands. The final step is applying for the manu- facturing authorization for investigational medicinal products. At present, we possess manufacturing authorization for an autologous cartilage transplant. Range of services Cell culture technology of primary human cells and specific 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) ¡¡ Modern digital image processing techniques such as microdissection ¡¡ Raman spectroscopy and multiphoton microscopy 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 biology Development of specific computer-controlled bioreactor systems for the culture of 3D 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 regulations) State-of-the-art equipment such as an inverse fluores- cence microscope, a multiphoton microscope system, a Raman spectroscope, FACS and PALM microdissection in- strumentation GMP production unit (cleanrooms, separate quality control area, storage facilities) Contacts 57