Strategy for streamlining antibody–drug conjugate pharmacokinetic assays
Summary
Antibody–drug conjugates (ADCs) have reemerged as a transformative therapeutic modality, with over a dozen approvals and hundreds of candidates in clinical development. Historically, ADC pharmacokinetic (PK) evaluation required measuring all constituent components – total antibody (TAb), conjugated antibody (ADC), or conjugated payload, free payload, and major metabolites. This comprehensive approach led to a significantly higher bioanalytical (BA) investment, increased patient blood volume requirements, and far more resources than those needed for monoclonal antibody (mAb) therapeutics or small molecule drugs. In...