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Accelerō® Bioanalytics GmbH is a certified GLP test facility, and operates in compliance with ICH GCP regulations. Competent authorities approved Accelero´s Biosafety Level S2 laboratories for both microbiology and genetic engineering.
Accelero Bioanalytics provides expertise in a continuously increasing number of applications: Non-Clinical Studies (GLP) Assay validation, PK/PD bioanalysis for non-GLP DRF and GLP Toxicology Studies Clinical Studies (ICH GCP) Analytical services according to ICH E6 R1 and the Declaration of Helsinki Advanced Therapy Medicinal Products (ATMP) Assay validation for the biodistribution of cell-based genetically engineered drug products RNA / DNA Therapeutics and Aptamers Micro RNA (miRNA) mimics and antagomirs, siRNA, antisense, aptamers, or immuno modulators Microbiology From cultivation to detection or quantification of BSL-2 microbial organisms Human PBMC Isolation and Cell Culture We culture your cell line, or characterize PBMC sub-populations Anti-Drug Antibodies (ADA) Immunogenicity testing for early IgM and late IgG immune response to your drug product GMP Cell Bank Characterization MCB and WCB insert characterization , impurity tests for drug products
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