Structural characterization methods for biosimilars: fit-for-purpose, qualified or validated

Author(s): Richard L Easton, BSC (Hons), DIC, PhD

Abstract: Detailed and accurate structural characterization of biopharmaceuticals is of paramount importance for product definition, assessment of impurities and achieving in-depth understanding of manufacturing processes. But how can we have confidence in the data obtained from characterization studies? The expectation from regulatory authorities when assessing methods for product characterization is that there will be some […]

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