Antibody-drug conjugates (ADCs) represent a revolutionary class of targeted cancer therapies, combining the specificity of monoclonal antibodies with the potency of cytotoxic drugs. However, their complex structure—comprising an antibody, linker, and payload—demands rigorous bioanalytical characterization to ensure safety and efficacy. ADC bioanalytics plays a pivotal role in this process, enabling researchers to assess critical quality attributes (CQAs) such as drug-to-antibody ratio (DAR), stability, and pharmacokinetics (PK).
Why ADC Bioanalytics is Critical
ADCs are inherently heterogeneous due to variations in conjugation sites and DAR distribution. Unlike traditional biologics, they require specialized analytical techniques to evaluate:
Drug-to-Antibody Ratio (DAR) – Determines the average number of drug molecules per antibody, impacting efficacy and toxicity.
Payload Release & Stability – Ensures the cytoto