A Combined Workflow for In-Depth Characterization of Cysteine-Conjugated Antibody Drug Conjugates (ADCs)

摘要

The structural complexity and intrinsic heterogeneity of antibody drug conjugates (ADCs) impose a prominent analytical challenge to current characterization methods. In this study, we present an analytical strategy of integrating several orthogonal methods for the in-depth characterization of critical quality attributes (CQAs) of ADCs, including drug-to-antibody ratio (DAR), drug distribution, drug conjugation sites, and conjugate site occupancy. The cysteine-conjugated IgG1 ADC samples evaluated in this study were synthesized with increasing drug conjugate load.