Standardize GMP Potency Validation

Standardizing Phase-Appropriate Validation of GMP Potency Bioassays: 2010 AAPS National Biotech Conference

Author: Ana T. Menendez, PhD

Potency bioassays are an integral part of release testing and stability studies for biotechnological products. Staged validation of analytical procedures is generally understood. However, due to the unique nature and perceived variability of bioassays, there remains ambiguity of bioassay expectations at each clinical phase to maintain scientific rigor and meet regulatory expectations. This poster provides a fit-for-purpose approach to validate potency bioassays from preclinical development throughout final commercial implementation.