This article provides updated recommendations for the bioanalysis of antibody-drug conjugates (ADCs), reflecting more than a decade of advances in the field. Developed by the AAPS ADC Working Group, it addresses key considerations for quantifying total antibody, conjugated ADC, free payload, and drug-to-antibody ratio (DAR), as well as immunogenicity, soluble target interference, critical reagent lifecycle management, stability, cross-validation, and regulatory strategy. The paper emphasizes that ADC bioanalysis requires a multifaceted, phase-appropriate approach tailored to the complexity and evolving nature of these therapeutics, and highlights bioanalysis as a strategic component of ADC development from preclinical studies through regulatory submissions.
Read the article featured in the July 2026 edition of The AAPS Journal.
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