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Tag: regulatory expectations surfactants

Surfactants in Biologics: Enhancing Product Stability

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Surfactants in Biologics: Enhancing Product Stability How Surfactants Improve the Stability of Biologic Drug Products Maintaining the stability of biologic drugs is essential to ensure therapeutic effectiveness and regulatory compliance. As biopharmaceuticals are prone to denaturation, aggregation, and degradation under stress, surfactants have become indispensable excipients in modern biologic formulation. This guide explores how surfactants…

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  • Prepare Expiry Justification Reports to Support Regulatory Queries and Renewals

    Understanding the Tip: What are expiry justification reports: Expiry justification reports are formal documents that summarize the rationale behind an assigned shelf life.
    They compile… Read more

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