Eurofins DiscoverX expanded its CRO Certification Program for Bioassays with Catalent Biologics as a North American provider certified in the program. As a certified provider of PathHunter assay services, Catalent Biologics' Morrisville/RTP facility in North Carolina has successfully demonstrated its capability to implement multiple client-sponsored GLP validation programs using the PathHunter assay platform to perform highly reproducible potency lot release assays under GLP/GMP conditions.
Eurofins DiscoverX launched the CRO certification program to support the growing needs of pharma and biopharma companies to partner with CROs and CDMOs to run potency lot release programs for bioinnovator and biosimilar drugs. This certification provides biopharma developers a platform to access experienced biologics analytical labs that can, in an expedited manner, provide potency and nAB study support.
Biopharma product developers have to prove drug products are safe and effective. While potency can be determined using a binding assay, regulators often require the use of a functional cell-based mechanism of action (MOA)-reflective assay, like PathHunter bioassays, that mimics conditions in living cells when the molecule allows for it for potency lot release studies.