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Pharma Stability: Insights, Guidelines, and Expertise

Tag: thermal degradation biologics

Real-Time Stability Testing for Temperature-Sensitive Biologics

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Real-Time Stability Testing for Temperature-Sensitive Biologics Designing Real-Time Stability Studies for Temperature-Sensitive Biologics Temperature-sensitive biologics, including monoclonal antibodies, vaccines, peptides, and biosimilars, require carefully designed real-time stability testing programs. Unlike small molecule drugs, biologics are susceptible to physical and chemical degradation even at mild temperature variations. This guide provides pharmaceutical professionals with a structured approach…

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