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ePaper created 2016-03-17, 15:06:18 | version 1.45.01
13 Good laboratory practice (GLP) test facility Several tests are running at our category 9 GLP unit (“Cell- based test systems for the determination of biological parameters”). Within this GLP unit we support research and development projects that investigate different biological parameters of samples/substances using cell-based assays. Examples are testing bioactivity of antiviral compounds or immunogenicity of compounds using immune receptor-based assays, the detection of pyrogens and microbial residues (pathogen-associated microbial patterns, PAMPs) as well as the screening of TLR agonists/antagonists and antimicrobial substances. 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 certified MP unit in tuttgart also for collaborative devel- opment with partners from industry. Various manufacturing authorizations (collagen, cartilage, skin, blood vessels, and adult stem cells) have already been granted. 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 biomolecular analytics diagnostic microarrays, protein e pression profiles, protein analysis using MALDI-TOF/TOF mass spectrometry (also quantitative) Next-generation sequencing De novo genome/transcriptome sequencing, meta-genomics and meta-transcriptomics, microbiomics, next generation diagnostics (infectious diseases, COPD, etc.) Cell biology analysis cell characterization, single cell preparation/microdissection, flow cytometric analyses, uality and sterility control of tissue engineering products Cell-material interactions testing of cytotoxicity/biocompatibility of medical devices, as- sessment of phototoxicity of substances and solutions, evalua- tion and testing of chemicals (REACH) and nanomaterials For detailed information on the analytical services we offer, please visit: www.igb.fraunhofer.de/analytics