Charge variants analysis of monoclonal antibodies

Arnaud Delobel
Claire I. Butré

Charge variants are considered as a Critical Quality Attribute of therapeutic monoclonal antibodies, as they can have a significant impact on the efficacy of the drug. State-of-the-art analytical techniques are required to both quantify and identify the variants. In this application note, we present the portfolio proposed by Quality Assistance, including capillary isoelectric focusing (cIEF) and ion-exchange chromatography (IEX), with applications to commercial monoclonal antibodies. Approaches based on (2D-)LC/MS are presented for the identification of the variants.

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