Drug Makers Urged to Develop Potency Assays Incrementally - and Start Early
Incremental potency assay development encouraged by FDA. Approach taken in recent guidance for cellular and gene therapy products makes sense for traditional drug products as well, FDA says. Three assay methods recommended. Early start encouraged. Industry comments generally supportive. Challenges developing potency assays for biopharmaceuticals and pros and cons of cell-based vs. binding assays discussed at conference. One key to better assays seen as knowing the mode of action.
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