SCI & TECH● LOWOct 5 · Oct 5, 2026, 7:07 AM
Standardising cell-based potency assays for biologics lot release: the case for cryopreserved ready-to-use cell systems (part II)
manufacturingchemist · united kingdom · global
Standardised cell systems can reduce biological variability, but robust potency testing must also demonstrate accuracy, precision and linearity. ICH Q2(R2) provides the framework to establish this analytical confidence
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