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Tag: QbD stability biologics

Biologics and Specialized Stability Testing: Strategies for Lifecycle Integrity

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Biologics and Specialized Stability Testing: Strategies for Lifecycle Integrity Biologics and Specialized Stability Testing: Strategies for Lifecycle Integrity Introduction Biologic products—including monoclonal antibodies, recombinant proteins, peptides, cell-based therapies, and vaccines—present unique challenges in pharmaceutical stability testing due to their molecular complexity and susceptibility to environmental stressors. Unlike small molecules, biologics are sensitive to temperature, light,…

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Biologics and Specialized Stability Testing

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  • Start Stability Protocol Design with ICH Q1A(R2) Guidance

    Tip: Always refer to ICH Q1A(R2) before designing a stability protocol to align with global regulatory expectations.
    Understanding the Tip: Why protocol design matters: Stability protocols define how long a pharmaceutical product remains safe and effective… Read more

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