Antibody-Drug Conjugates (ADCs) have become a promising modality for targeting challenging cancers, boasting 12 approved therapies and numerous candidates in clinical trials. The development of next-generation ADCs introduces significant challenges in the analytical characterization of both drug-linkers (DLs) and ADCs themselves. In this presentation, I will outline the comprehensive strategy our team has developed for ADC and DL characterization, highlighting the robust analytical toolkit we have established. We will explore multiple workflows, including molecular assessments of DLs, and introduce several innovative analytical assays including a HIC-MS method for characterizing varying drug-to-antibody ratios (DAR) species, providing detailed insights into ADC heterogeneity as well as using it as a process analytical technology (PAT) tool. Our strategies and analytical methodologies pave the way for more effective development and characterization of next-generation ADCs, ultimately contributing to better therapeutic outcomes for patients with hard-to-treat cancers.
