Biologic Potency Testing

IITRI offers in vitro and in vivo assays for potency testing related to manufacturing lot release of licensed biologic pharmaceutical and vaccine products. These potency assays are conducted in compliance with the current Good Manufacturing Practices (cGMP, 21 CFR Parts 210 and 211) and Good Laboratory Practices (GLP, 21 CFR Part 58). Assays are designed and conducted to meet the requirements of our Client/Sponsor and federal regulations (FDA).

In vitro assays include validated ELISA assays, and in vivo assays include animal challenge studies in rodents, rabbits, or NHPs, and immunogenicity assays. Our high containment facility is available for testing with BSL-2 or BSL-3 pathogens.

Quality Standards

  • Our QA standards include using qualified reagents, qualified and calibrated equipment, and thoroughly trained and qualified staff
  • Certificates of analysis (CofA) are provided
  • New and/or modified potency assay development and validation services are available