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Tag: temperature controlled biologic testing

Real-Time Stability Testing Requirements for Biologics

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Real-Time Stability Testing Requirements for Biologics Real-Time Stability Testing Requirements for Biologics Real-time stability testing is the gold standard for determining the true shelf life of biopharmaceuticals. Unlike accelerated testing, which exposes products to stress conditions, real-time studies simulate the actual storage environment over the full duration of intended use. Regulatory authorities mandate real-time data…

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  • Real-Time Stability Data Required for Each Batch of Biological Products

    Understanding the Tip: Why biologics need batch-specific stability monitoring: Biological products—such as monoclonal antibodies, vaccines, cell-based therapies, and recombinant proteins—are inherently complex and sensitive to… Read more

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