Current Chromatographic Strategies for Intact mAb and ADC Analysis

Characterizing intact biotherapeutics such as monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs) under physiological conditions is essential for understanding their critical quality attributes. This paper will examine several advanced chromatographic and detection solutions—including SEC, HIC, affinity chromatography, MALS, and HRMS—to support structural analysis, molecular weight determination, and DAR quantification.