What FDA CRLs Reveal About Cell-Based Potency Assays

Cell-based potency assays have a wide-reaching role in establishing the critical quality attributes of a drug, extending far beyond lot or batch release. But that versatility comes with complexity: they are also among the most challenging assays to develop, validate, and maintain.

In our analysis of FDA Complete Response Letters (CRLs), we found many instances where cell-based potency assay deficiencies contributed to regulatory concerns.

Download our white paper to learn what issues are driving these CRLs and how to build a stronger cell-based potency assay strategy.