Characterization of Antibody Drug Conjugate (ADC) Payloads Using High-Resolution Mass Spectrometry
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Antibody-drug conjugates (ADCs) have emerged as a promising strategy in targeted drug therapies. Currently, three ADCs have received approval from the U.S. FDA, with an additional ten candidates progressing through late-stage clinical trials. Maintaining the stability and integrity of the antibody-cytotoxic agent linkage throughout drug development and manufacturing is essential to ensure both safety and therapeutic effectiveness. Monoclonal antibody-based drugs have proven to be highly effective tools for delivering targeted therapeutic activity specifically to disease sites. ADCs consist of disease-specific monoclonal antibodies conjugated with one or more cytotoxic molecules. This technical note highlights Trastuzumab emtansine (T-DM1), a lysine-linked ADC conjugated with up to 8 drug molecules, which was analyzed using high-resolution Orbitrap technology to accurately determine the antibody-to-drug ratio (DAR).