The Competence Center for Advanced Therapy Medicinal Product (ATMP) Development at the Berlin Center for Regenerative Therapies will host a symposium on "Trends and perspectives in the development, approval and reimbursement of ATMPs and combined medical devices".
The event will take place on Thursday, 24th of January 2013. If you would like to get in touch with us, please use our contact form to arrange an appointment.
Representatives from authorities, clinical test sites, GMP manufacturers as well as research institutes will provide an opportunity to discuss regulatory issues and the recent developments in preclinical/clinical requirements for ATMP approval.
Accelero Bioanalytics GmbH is a privately-held bioanalytical start-up located in the Berlin city center. The company maintains a biosafety level 2 lab in a Good Laboratory Practice (GLP) environment, an ideal combination for the bioanalysis of ATMPs like novel gene therapeutics as well as cell-based products. Accelero Bioanalytics develops and validates customized ligand binding assays for PK/PD and companion diagnostics according to EMA and ICH guidelines:
ELISA and AlphaLISA immunoassays in 96well and 384well format
Real-Time RTqPCR assays for imputity tests, transgene copy number quantification, biodistribution of ATMPs