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Pharma Stability: Insights, Guidelines, and Expertise

Tag: [freeze-thaw protein aggregation

Impact of Freeze-Thaw Stress on Protein Aggregation in Biologics

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Impact of Freeze-Thaw Stress on Protein Aggregation in Biologics Understanding the Impact of Freeze-Thaw Stress on Protein Aggregation in Biologics Freeze-thaw stress is one of the most critical challenges in ensuring the stability of biologic drug products. Unlike small molecule drugs, biologics such as monoclonal antibodies, fusion proteins, and peptides are highly sensitive to thermal…

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Freeze-Thaw and Thermal Cycling Studies, Stability Testing Types

Aggregation as a Stability Indicator in Biologics

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Aggregation as a Stability Indicator in Biologics Protein Aggregation in Biologics: A Critical Indicator of Stability and Quality In the realm of biopharmaceuticals, protein aggregation is a pivotal indicator of product stability, quality, and safety. Aggregation not only impacts the biological activity of the drug but also poses a serious risk of immunogenicity in patients….

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Stability Testing for Biopharmaceuticals, Stability Testing Types

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  • Maintain Backup Stability Chambers to Prevent Data Loss in Case of Failure

    Understanding the Tip: Why backup chambers are essential: Stability chambers are critical infrastructure in pharmaceutical QA.
    A sudden malfunction—due to power failure, temperature controller breakdown,… Read more

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