UHP-SEC Analysis of Biosimilars Using Size Exclusion Chromatography

contributed by Tosoh | 09/17/2018

A biosimilar is a biological medicine highly similar to an approved biological medicine (originator) in terms of structure, biological activity and efficacy, safety and immunogenicity profile. In order to demonstrate biosimilarity, the biosimilar manufacturer must generate an array of data comparing the proposed product to the approved reference product; a detailed analytical characterization and comparison of the products marks the first step in this process.

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