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FDA panel: qualify potency assays before pivotal trials and validate before BLA
Summary
FDA reviewers said assay qualification should precede pivotal studies and full assay validation should be completed before a BLA; validation should demonstrate accuracy, precision, linearity, robustness, and consistency across operators and reagent lots.
Dr. Karen Knudsen clarified the difference between assay qualification and assay validation and recommended sponsors consider assay performance throughout development. "The key difference between assay qualification and assay validation is the rigor by which the assay itself is tested," she said, adding that "before submitting a BLA, all assays should be fully validated and demonstrated to be suitable for their intended purpose."
Panelists advised sponsors to establish potency assay acceptance criteria early and narrow ranges as additional manufacturing and clinical experience is gained. They also recommended thinking about validation needs at the assay design stage, and to seek additional FDA guidance and meetings if assay qualification or validation are predicted to be problematic.
