Development of a novel, high-throughput imaged capillary isoelectric focusing-Western method to characterize charge heterogeneity of monoclonal antibody heavy and light chains.

Charge heterogeneity is one of the commonly monitored quality attributes in biotherapeutics. It can impact the stability, efficacy, and safety of products, but it can also affect the pharmacokinetics, binding affinity, and overall biological activity of the molecules. Given the substantial size and complexity of antibodies, subtle variations or specific modifications that result in charge heterogeneity might be concealed when mAbs are analyzed under native conditions.