Industry Practices in Monoclonal Antibody Tissue Biodistribution Assessment: An IQ Consortium Cross-Industry Survey of Current Approaches and Emerging Trends

Abstract

Tissue biodistribution characterization represents a critical component of monoclonal antibody (mAb) development, yet industry practices remain fragmented despite regulatory emphasis on comprehensive exposure assessment. The IQ Consortium Tissue Concentration Working Group surveyed eleven pharmaceutical companies to evaluate current methodologies in mAb tissue concentration analysis and establish consensus recommendations. Organizations demonstrated heterogeneous portfolio compositions, with traditional monospecific IgG1 and IgG4 platforms dominating 81.8% of companies while next-generation multispecific formats and antibody–drug conjugates gained prominence. Strategic approaches to biodistribution evaluation differed markedly, as 72.7% implemented compound-dependent assessment protocols versus systematic screening paradigms. Peak measurement activity occurred during lead optimization phases (63.6%) and pre-clinical candidate advancement (54.5%), reflecting resource optimization rather than mechanistic investigation priorities. Universal adoption of ligand binding methodologies complemented mass spectrometry integration in 81.8% of programs, though analytical validation standards exhibited substantial inconsistency. Blood contamination correction procedures were systematically implemented by merely 18.2% of respondents, indicating widespread methodological gaps. While tissue concentration datasets informed translational pharmacokinetic modeling across 81.8% of organizations, physiologically-based modeling frameworks remained underutilized. Results underscore urgent requirements for analytical harmonization to strengthen regulatory submissions and accelerate therapeutic development timelines.

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