Precise Characterization of Intact Monoclonal Antibodies

Monoclonal antibodies (mAbs) are a very important class of biopharmaceutical molecules. As a protein drug, thorough characterization of the mAb is required in each of the manufacturing steps. Intact mAb analysis offers rapid assessment on determining the accurate molecular weight of an mAb product and its degree of heterogeneity, such as post-translational modifications (PTMs), antibody-drug conjugate (ADC), mAb sequence variations, or degradation products. Quadrupole Time-of-flight (Q-TOF) LC/MS systems are often used to analyze intact proteins or antibodies due to excellent resolution at the high mass range. This application note describes a seamless workflow using the Agilent 1290 Infinity II UHPLC system, 6545XT AdvanceBio LC/Q-TOF, and automatic data processing with Agilent MassHunter BioConfirm software to analyze a variety of mAb products.