Bioanalysis of antibody–drug conjugates: current practices and future directions—a workshop report

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.