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Pharma Stability: Insights, Guidelines, and Expertise

Tag: analytical similarity stability

Real-Time Stability Challenges in Biosimilar Development

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Real-Time Stability Challenges in Biosimilar Development Overcoming Real-Time Stability Challenges in Biosimilar Development Biosimilars, as highly similar versions of licensed biologics, must demonstrate equivalent safety, efficacy, and quality to their reference products. One of the critical components of biosimilar development is the generation of robust stability data—particularly real-time stability studies that support shelf-life, comparability, and…

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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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