What FDA’s 2026 Draft Guidance Means for Antibody Drug Conjugates

Sponsored by Waters Corporation

As FDA’s June 2026 draft guidance moves to reduce reliance on animal studies for antibody-drug conjugates (ADCs) and other conjugated products, analytical characterization must take on more of the responsibility for demonstrating product safety. Deanna Hunt, Senior Director of Business Development at KBI Biopharma, explains this shift places additional pressure on orthogonal analytical techniques, including mass spectrometry, to confirm that what is being measured accurately reflects a molecule’s real-world impact in clinical use. The complexity introduced by novel, less-platformed molecules make this pressure more acute, since well-established platforms allow teams to draw on known liabilities while novel chemistries do not. Despite the new guidance, ICH Q6B remains the prevailing standard, calling for characterization to the greatest extent possible using the most current available techniques. Both the available techniques and the interpretation of that standard continue to evolve alongside the field.