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Tag: pH stability study protocol]

pH Sensitivity and Its Role in Biologic Drug Stability

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pH Sensitivity and Its Role in Biologic Drug Stability Understanding pH Sensitivity in Biologic Drug Stability: Mechanisms, Testing, and Control Strategies pH is a critical parameter that profoundly influences the stability of biologic drug products. Proteins, monoclonal antibodies (mAbs), peptides, and other biotherapeutics are sensitive to even minor pH shifts, which can lead to chemical…

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  • Use Statistical Tools to Evaluate Analytical Trends in Stability Studies

    Understanding the Tip: Why visual inspection isn’t enough: Visually scanning stability data can give a false sense of consistency or overlook subtle trends that indicate… Read more

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