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Pharma Stability: Insights, Guidelines, and Expertise

Tag: biologic API light sensitivity

Light-Triggered Structural Changes in Biologics

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Light-Triggered Structural Changes in Biologics Understanding Light-Induced Structural Changes in Biologics: Risks and Mitigation Biologic drug products—including monoclonal antibodies, peptides, and recombinant proteins—are complex molecules susceptible to structural modifications upon exposure to light. These changes can compromise product efficacy, trigger immunogenic responses, and lead to regulatory challenges. This guide outlines the mechanisms by which light…

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  • Fully Validate Stability-Indicating Methods Before Use in Studies

    Understanding the Tip: What is a stability-indicating method: A stability-indicating method is an analytical procedure that accurately and specifically measures the active pharmaceutical ingredient (API)… Read more

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