Biologic Potency Testing
IITRI offers potency assays for the release and stability testing of licensed biological drug product manufacturing lots, including vaccines. These 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)
- Our QA standards include using qualified reagents, qualified and calibrated equipment, and thoroughly trained and qualified staff
- Certificates of analysis are provided
- New and/or modified potency assay development and validation services are available