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 is proud to serve our clients with: • OECD GLP approved facilities for analytical, non-clinical studies. • ICH E6 R1 GCP compliant analytical facility for clinical phase 0 to 3 studies. • Facility approved for handling and cultivation of BSL-2 micro-organisms (bacteria, yeasts). • Facility approved for genetic engineering / cloning / analysis of safety level S2 GMOs (bacteria, yeasts, viruses, plants, animals). • Approval for the import and analysis of animal by-products from non-EU countries (e.g. like U.S.A., China). Accelero services include, but are not limited to: • Pharmacokinetic / toxicokinetic characterization (ELISA, qPCR, immuno qPCR). • Biodistribution and shedding (qPCR). • Biomarker screening on the RNA level (qPCR, microarray) and the protein level (microarray). • Cell-based in vitro immunoassays (ELISA, EliSpot, flow cytometry). • Particle-based multiplex immunoassays (flow cytometry). • Particle-based multiplex miRNA (microRNA) assays (flow cytometry). • Cell proliferation and cytotoxicity assays (flow cytometry, EliSpot). • Gene expression assays (RTqPCR). • GLP training services (basic courses, in-house trainings). • Antibody detection assays (ADA): screening, confirmatory, neutralization (EliSPOT). • Preclinical consulting services with regards to GLP and bioanalysis. • Complement activation monitoring. • Supply chain services e.g. like sample transport and shipping organisation, preparation of clinical kits. All analytical methods are developed and validated according to the respective EMA, FDA, and/or ICH guidelines. Accelero® is a trademark fully owned by Accelero Bioanalytics GmbH, Berlin (Germany). Last update of this page: 31-DEC-2017 by CL