Structural mass spectrometry in biologics discovery: advances and future trends

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Biologics produced by recombinant DNA technologies are generally complex, heterogeneous, and subject to a variety of modifications. The biological efficacy, clearance, safety and immunogenicity of biologics are highly dependent on their structures. Therefore, there is a growing need for protein structural characterization, particularly during the drug discovery phase when a large number of candidates are being investigated.

Mass spectrometry (MS) is one of the key techniques in protein characterization. In this article, the workflow for MS-based structural characterization of biologics in biopharmaceutical drug discovery is presented, including characterization of primary and higher order structures. Advances in MS techniques in protein characterization are illustrated, including electron transfer dissociation MS (ETDMS) for primary structure analysis and hydrogen/deuterium exchange MS (HDX-MS) for probing protein higher order structures and mapping epitopes. Future trends in applications of MS to evaluate and optimize candidate molecules in biologics stability studies is also described.

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