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Prof. Dr. rer. nat. Katja Schenke- Layland Head of Department, Director (executive, acting) Phone +49 711 970-4082 katja.schenke-layland@igb.fraunhofer.de Prof. Dr. rer. nat. Petra Kluger Head of Department Phone +49 711 970-4072 petra.kluger@igb.fraunhofer.de Contact erivation of tissue-specific cells from pluripotent and adult stem cells esign of tissue-specific, computer-controlled bioreactors Establishing methods for the non-destructive characteriza- tion of cells and tissues by Raman microspectroscopy and multiphoton microscopy ADMET (absorption, distribution, metabolism, excretion and toxicity) are pharmacokinetic and toxicological properties that must be tested during drug development. Using our test 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 replacement, 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 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. Range of services Cell culture technology of primary human cells and mam- malian cell lines ¡ In vitro testing of cytotoxicity according to DIN ISO 10993-5 ¡ In vitro testing of phototoxicity according to OECD guideline 432 and INVITTOX protocol no 121 Cell biology analysis ¡ Molecular-biological, histological and immunohistologi- cal methods ¡ Flow cytometry (FACS) ¡ Modern digital image processing techniques such as microdissection ¡ Raman microspectroscopy and multiphoton microscopy Establishing of various 3D tissue models ¡ Alternatives to animal testing ¡ ADMET testing in substance and drug screening ¡ Target screening for new therapeutics and infection biology ¡ ab-on-a-chip microfluidics systems evelopment 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) tate-of-the-art e uipment such as an inverse fluores- cence microscope, a multiphoton microscope system, a Raman microspectroscopic system, FACS and laser-capture microdissection instrumentation GMP production unit (cleanrooms, separate quality control area, storage facilities) 47 Phone +49711970-4082 Phone +49711970-4072