Access the slides of this 45 minute webinar to learn how state-of-the-art LC/MS technologies can be implemented for the efficient study of ADCs using analyses optimised for each level of information you need. 

Analytical performance of the different solutions proposed will be discussed, together with the presentation of numerous experimental results (with advantages and drawbacks) obtained during method development and optimisation.

We presented efficient and optimised approaches for the characterisation of ADCs by mass spectrometry, based on different levels of analysis: 

• Intact protein for Drug-to-Antibody Ratio determination
• Substructures (after IdeS / FabRICATOR digestion) 
• 2D-LC/MS (HIC-RP) for DAR determination and identification of the different isoforms 
• Peptide mapping for determination of conjugation sites and site-occupancy 

Applications of these methods to KADCYLA^® and/or ADCETRIS^® were also presented. 

The performances and limitations of the different analytical approaches were also discussed.

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.