Biologics >> Characterization of Biologics >> Physico-chemical and Biochemical characterization

Physico-chemical and Biochemical characterization

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To ensure a safe and well controlled biological product, it is required that both activity and biochemical properties are well described. The API should be extensively characterized in terms of composition, the presence of heterogeneities, and higher order structure. To provide a safe biologic, one needs to demonstrate analysis of:

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