![]() In this proof-of-concept study, a two-dimensional liquid chromatography (2D-LC) approach was successfully applied to mAb forced degradation samples for evaluation of size distribution in the IEC charge profile. ![]() The degraded samples are subject to characterization using a wide array of analyses, including ion exchange chromatography (IEC) for charge variants and size exclusion chromatography (SEC) for size variants. Forced degradation study is a common practice to assess the potential modifications and degradation pathways of mAbs upon extreme conditions, including light exposure and extreme local pH. Monoclonal antibody (mAb) products are extraordinarily heterogeneous due to the presence of a variety of enzymatic and chemical modifications, such as deamidation, isomerization, oxidation, glycosylation, glycation, terminal cyclization, aggregation, and fragmentation.
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