Accelero Bioanalytics GmbH, a small biotechnology platform focussing on custom-made ligand binding assay development and validation, is now proud to initiate the certification process according to the German Chemikaliengesetz (ChemG). Main topic is to receive an official GLP certificate granted by the German authority.
Accelero´s innovative business model fills the gap between young Biotech´s need for ligand binding assay development capabilities, and the experience to bring these assays in line with regulatory requirements for IND filing. Our small team does not only provide extensive hands-on expert knowledge, but also a strong background in the field of preclinical drug development in compliance with Good Laboratory Practice (GLP).
The main GLP inspection is expected to be completed by end of June 2015. Accelero Bioanalytics will then maintain a Quality Assurance Unit which fully comply to the OECD guideline No.1.
For Accelero´s customers, this construct will create the pleasant situation to receive PCR and ELISA based services from the assay design to the final pharmacokinetic reporting to EU authorities, all provided from one hand. Accelero is on the best way to become the bioanalytical and quality assurance consultant of choice.
Accelero Bioanalytics team is exclusively formed by academic staff with a strong background in biotechnology, toxicology, and molecular biology. Our team will maintain a genetic engineering safety level S2 area joined to GLP in summer 2015, an ideal combination for ATMP drug development or biopharmaceutical manufacturing in-process quality control.