Charge heterogeneities are crucial quality attributes of therapeutic proteins and have profound influence on the safety and efficacy.Selecting the reliable detection methods are essential to support both upstream and downstream process development and manufacturing of therapeutic proteins.In recent years,the focus of charge heterogeneities analysis has gradually developed from the analysis of charge heteromers to structures,and biological activity assessments.In this paper,we review the the source,structural characterization,classical analytical methods and activity analysis analysis methods of charge heterogeneities and recent advancements in ion exchange chromatography(IEX),whole column imaging detection capillary isoelectric focusing(WCID-CIEF)for the qualitative analysis of charge variants,aiming to provide methodological references for drug development.
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