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Pharma Stability: Insights, Guidelines, and Expertise

Tag: storage excursion risk

Freeze-Thaw Stability Evaluation of Biologics

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Freeze-Thaw Stability Evaluation of Biologics Freeze-Thaw Stability Evaluation of Biologics: Strategies and Best Practices Freeze-thaw stability testing is a critical component in the development and lifecycle management of biopharmaceuticals. Many biologic drug substances and drug products require frozen storage to preserve potency and minimize degradation, but freezing and thawing can induce stress that compromises product…

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  • Track Trends and Promptly Flag OOS/OOT Data in Stability Studies

    Understanding the Tip: Why trend analysis matters in stability programs: Trend analysis in stability studies provides insights into the gradual evolution of product quality over… Read more

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