Dr Richard L Easton and Dr Andrew J Reason at BioPharmaSpec discuss how the development and production of any protein biologic relies on sound and robust structural data to demonstrate that the correct molecule has been produced. The data should allow an assessment of all relevant attributes of the molecule and from these data, in conjunction with bioassay information, conclusions can be drawn regarding structure and function. This is particularly true for biosimilars, where analytical data is the foundation of any biosimilarity claim.
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