June 29, 2020 -- Eurofins DiscoverX has expanded its contract research organization (CRO) certification program for bioassays with Catalent Biologics as the North American provider.
From its Morrisville, NC, facility in the Research Triangle Park area, Catalent can support multiple client-sponsored good laboratory practice (GLP) validation programs using the PathHunter assay platform to conduct potency lot release assays under GLP/good manufacturing practice (GMP) conditions.
The DiscoverX program was launched to support biotechnology and pharmaceutical companies and conduct potency lot release programs for bioinnovator and biosimilar drugs. The certification provides a platform to access experienced biologics analytical labs to provide potency and neutralizing antibody study support.
Now, the bioassay certification program will play a role in helping product developers prove that their drug products are safe and effective, i.e., potent. While potency can be determined using binding assays, regulators often require functional cell-based mechanism of action-reflective assays such as PathHunter.