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.