Article FDA Thank You Draft guidance on potency assays for CGT products garners extensive stakeholder input
Agency IQ
APRIL 12, 2024
Assays are tests designed to assess various properties (like potency) of chemical or biological samples. For therapeutic protein products , a critical use of assays is the detection and assessment of potential anti-drug antibody (ADA) formation, signaling a product’s potential to induce an unwanted immune response.
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