Development and use of 2D-LC/MS as a versatile and powerful tool for the analysis of mAbs and ADCs in a regulated environment

In the recent years, monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs) have emerged as potent and specific anticancer agents. However, due to their size, complexity, and heterogeneity, their physico-chemical characterisation requires a large number of assays aimed at verifying their sequence identity, post-translational modifications, and – in the case of ADCs – range/average number of conjugated drugs (Drug-to-Antibody Ratio: DAR). To this end, we have developed a range of analytical workflows employing mass spectrometry, in a regulated environment, to support pharmaceutical companies in the development and control of their mAbs and ADCs.