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The immediate and long-term impact of temperature deviations that may occur in clinical practice on live attenuated influenza vaccine (LAIV) potency was examined in four distinct studies that exposed vaccine to freeze/thaw cycles, warming, and heating conditions. No significant loss of vaccine potency was observed after three freeze/thaw cycles, warming of vaccine to 15°C (59°F) for 72 hours or less,...
Assay validation is the characterization of assay performance that allows the significance of the values obtained in an assay to be evaluated. Biological assays have several inherent sources of variation and this has been used as an excuse for years to explain unexpected or unanticipated results. However, with careful control of reagents and strictly controlled procedures, biological assays can be...
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