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2013|14 Annual Report Fraunhofer IGB

11 GMP unit for manufacturing of clinical materials The manufacturing of medical devices, investigational me- dicinal products (IMPs) and cell-based and tissue engineering products (e.g. ATMPs) for clinical trials requires processes ac- cording to Good Manufacturing Practice (GMP). We develop GMP-compliant manufacturing processes in our 215 m2 certi- fied GMP unit in Stuttgart – also for collaborative develop- ment with partners from industry. Different manufacturing authorizations (collagen, cartilage) have already been granted. Good laboratory practice (GLP) test facility Our area of expertise 9 GLP test facility (“Cell-based test systems for the determination of biological parameters”) is used in research and development projects for investigating different biological parameters of samples / substances using cell-based assays. Examples are the testing of bioactivity and immunogenicity, the screening of TLR agonists / antagonists and antimicrobial substances as well as the detection of pyrogens and microbial residues (pathogen-associated microbial patterns). Special services Physico-chemical analytics quality control, food analysis, trace analysis, analysis of resi- dues, environmental analytics, water analysis High resolution 400 MHz NMR analytics molecular structure elucidation, reaction monitoring, develop- ment of novel experimental NMR methods, low temperature analytics Surface and particle analytics characterization of chemical, physical and morphological properties of surfaces, thin layers, powders and particles Microbial evaluation testing of antimicrobial effects and photocatalytic properties of surfaces Biochemical and molecular biological analytics diagnostic microarrays, RNA and protein expression profiles, protein analysis using MALDI-TOF / TOF mass spectrometry (also quantitative) Cell biology analysis cell characterization, single cell preparation / microdissection, quality and sterility control of tissue engineering products Cell-material interactions testing of cytotoxicity / biocompatibility of medical devices and of bioavailability of drug candidates, evaluation and testing of chemicals (REACH) and nanomaterials For detailed information regarding our services and infrastructure, please visit: www.igb.fraunhofer.de/analytics

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