Feature|Videos|August 5, 2026
FDA’s 2026 Draft Guidance on Nonclinical Safety for Antibody Drug Conjugates
Key Takeaways
- Understand how FDA’s 2026 draft guidance shifts more of the safety-demonstration burden onto analytical characterization.
- Recognize why novel, less platformed bioconjugate molecules face greater analytical scrutiny than established platforms.
The FDA’s 2026 draft guidance shifts more responsibility onto analytical characterization for product safety.
Episodes in this series
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As FDA’s June 2026 draft guidance moves to reduce reliance on animal studies for antibody-drug conjugates (ADCs) and other conjugated products, analytical characterization must take on more of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.
Related Content
