IQ Workshop – Bioanalysis of Antibody-Drug Conjugates

BACKGROUND & FOCUS

GOAL & HIGHLIGHTS

Bioanalysis of ADCs is uniquely challenging, requiring multiple assays (e.g., total antibody, conjugated antibody, free payload, metabolites, immunogenicity) across preclinical and clinical phases. Current industry practice often “measures everything,” resulting in high costs, excessive time demands, and large sample volumes. The IQ Consortium’s Drug Conjugates Working Group, co-chaired by Faye Vazvaei-Smith (Merck & Co. Inc.) and Wenkui Li (Novartis) is driving consensus on best practices to make ADC bioanalysis more efficient and fit-for-purpose.

This full-day IQ Consortium workshop is focused on harmonizing and streamlining bioanalytical practices for Antibody-Drug Conjugates (ADCs), reducing unnecessary complexity and resource use while maintaining scientific rigor and patient safety.

The goal of this workshop is to develop clear consensus recommendations on which ADC constituent(s) should be measured—and when—enabling efficient fit-for-purpose bioanalysis across the stages of drug development. This includes alignment on:

• Which analyte(s)/assessment (e.g., total antibody, conjugated antibody, free payload, conjugated payload/metabolites/immunogenicity) are essential at each phase (preclinical, Phase I, pivotal studies, post-approval).
• When there is scientifical justification to start or stop measuring specific constituents.
• How to balance regulatory expectations with operational efficiency.

WORKSHOP HIGHLIGHTS