WebFeb 7, 2024 · The spectrum of test systems used to measure potency of biologicals includes. technically straightforward ligand-binding and enzymatic assays that use highly purified, typically consistent and stable … WebTailored cell-based bioassay or potency assays for biologics and biosimilars to meet the requirements of ICH Q6B and Good Manufacturing Practice (GMP) GMP cell-based potency testing quantitatively determines the biological activity of a biopharmaceutical. Measurement of potency plays an essential role in quality control, GMP product release …
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