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.
There is a regulatory expectation that the primary amino acid sequence of a biosimilar and its associated innovator will be determined. State-of-the-art instrumentation is available to allow this type of analysis to be performed and, with experience and knowledge of appropriate protein chemical techniques, strategies can be developed that allow full sequence coverage to be obtained.
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