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Characterisation of Biopharmaceutical Proteins

Over the next five years it is anticipated that there is going to be an explosion in the numbers of biosimilar products coming to market as patents expire. Consequently, in line with regulatory guidance, there will be a commensurate need to provide full characterisation of such biopharmaceuticals. The purpose of this article is to describe the array of the more common techniques used in biopharmaceutical characterisation (typically of protein or polypeptide). For full characterisation of a protein, the protein´┐Żs primary, secondary and tertiary structure as well as its physiochemical properties should be assessed.

Characterisation of Biopharmaceutical Proteins
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