Bioanalysis of antibody-drug conjugates: current practices and future directions-a workshop report.

Abstract

The International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) convened a workshop on bioanalysis of antibody-drug conjugates (ADCs) in March 2026, in Spring House, Pennsylvania. The one-day event brought together pharmaceutical industry scientists and regulatory agency representatives to discuss bioanalytical strategies for ADC development. This report summarizes key presentations-including an industry survey on the current practices, perspectives on ADC clinical pharmacology, and regulatory considerations-along with findings from breakout sessions focused on preclinical bioanalysis, pharmacokinetic assays and modeling, and immunogenicity assessments. Workshop participants generally supported early characterization of relevant ADC-related analytes, emphasizing that analyte selection should remain risk-based and molecule-specific and that measurement strategies may be streamlined when supported by data and, when appropriate, regulatory consultation. Emerging themes included the growing use of hybrid liquid chromatography-tandem mass spectrometry (LC-MS/MS) platforms, the central role of exposure-response modeling in dose optimization and assay strategy, and risk-based approaches to immunogenicity assessment. These discussions provide a foundation for advancing ADC bioanalytical best practices and regulatory alignment in this rapidly evolving therapeutic area.

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