Beyond measurement: a strategic perspective on antibody–drug conjugates bioanalysis from the European Bioanalysis Forum

Antibody–drug conjugates are a highly complex therapeutic modality that challenge conventional bioanalytical paradigms. Following a multidisciplinary workshop, the European Bioanalysis Forum developed a strategic perspective on how bioanalysis should evolve to support contemporary and future antibody–drug conjugates development. Central to this perspective is the recognition that antibody–drug conjugates are heterogeneous and dynamically changing therapeutic entities whose composition can be modified in vivo through processes such as deconjugation, payload release, linker cleavage, biotransformation and changes in DAR distribution, requiring bioanalysis to move beyond individual analyte measurements toward integrated biological understanding. The European Bioanalysis Forum proposes that bioanalytical strategies should be driven by clearly defined scientific questions and Context of Use, substantiated with additional complementary analytical approaches selected to generate evidence that supports development decisions. Rather than providing prescriptive methodological recommendations, this paper presents a flexible scientific framework that integrates multidisciplinary expertise and encourages continued scientific dialogue and publication of case studies to strengthen the evidence base as antibody–drug conjugates science continues to evolve.