Temperature Excursions and Interpreting Biologic Stability Data
Temperature Excursions and Interpreting Biologic Stability Data Handling Temperature Excursions and Making Stability-Based Decisions for Biologics Biologic drug products are highly sensitive to temperature fluctuations, requiring strict storage conditions—often 2°C to 8°C—for stability and potency preservation. However, in real-world settings, temperature excursions during transport, storage, or clinical distribution are sometimes unavoidable. This tutorial outlines how…
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