Module 9 2021

24/03/2021

What are Bioassays/ biological assays?

• Assessment of a biological substance’s activity

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Bioassays

ICH Q6B – Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products Examples of procedures: • Animal-based - measures organism’s biological response • Cell culture based biological assays – measure biochemical or physiological response • Biochemical assays – measure biological activities e.g. enzymatic reaction rates, ligand and receptor binding assays induced by immunological interactions

USP Chapters 1032, 1033

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