Monitoring oxidative stress of biologics

Biologics, particularly those based on monoclonal antibodies, are highly heterogenous with a variety of post- translational modifications (PTMs) including glycosylation, c-terminal clipping and n-terminal blocking. Some of these PTMs, such as oxidation or deamidation, could be induced via stress or storage conditions and may be critical quality attributes (CQAs) affecting efficacy and patient safety. Oxidation of proteins can be induced through dissolved or free radicals which could be generated via UV exposure or non-organic impurities. Methionine oxidation is a known and well characterised degradation of proteins, though antibody drug conjugates open up the potential for modifications on drugs and linkers. Oxidation of proteins can result in downstream losses if it occurs in a Protein A binding site or could reduce efficacy if the site is in the complementary determining region (CDR).

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