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Tag: ICH Q5E comparability HCP]

Host Cell Protein Impurities and Biologic Stability

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Host Cell Protein Impurities and Biologic Stability How Host Cell Protein Impurities Affect the Stability of Biologic Products In the development and production of biologic drugs, impurities can severely affect product stability, safety, and efficacy. Among the most critical impurities are Host Cell Proteins (HCPs), which are residual proteins from the expression system used in…

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  • Include Microbial Limits Testing in Stability Studies Where Applicable

    Understanding the Tip: What is microbial limits testing in stability studies: Microbial limits testing evaluates the total microbial count and the presence of specific objectionable… Read more

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