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Pharma Stability: Insights, Guidelines, and Expertise

Tag: biologics formulation stability testing

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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  • 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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