Monitoring pH stress of biologics

Biologics, particularly those based on monoclonal antibodies, are highly heterogenous with a variety of post- translational modifications (PTMs), including glycosylation, oxidation and deamidation. Some of these PTMs could be induced via stress or storage conditions and may be critical quality attributes (CQAs) affecting efficacy and patient safety. pH stress may occur during downstream biologics processing in cation or anion exchange chromatography, or during conjugation reactions if a pH adjustment is required for optimal attachment of a linker. Acidic or basic conditions may induce fragmentation of protein species or induce dehydration and deamidation. High pH can also lead to formation of soluble or insoluble aggregates.

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