https://www.selleckchem.com/pr....oducts/epz004777.htm
By doing so, bioassay accuracy and precision may be assessed with high confidence well ahead of commercial manufacturing. Further, by following the total-variance approach, the method also allows for the construction of control limits for potency.Freezing of biologics has been widely studied from the physical chemistry point of view, for instance in terms of cryoconcentration, excipient crystallization, pH swing, potential protein denaturation etc... At the opposite, considerations on processing aspects are very limited. For instance,
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