Sutro Biopharma enters research collaboration with FDA for ADC standards

Sutro Biopharma (STRO) entered into a collaboration with the U.S. Food and Drug Administration to develop reference materials to improve regulatory standards and enhance analytical methods for ADC drug development. The collaboration will leverage Sutro’s cell-free XpressCF technology to precisely engineer ADCs with predefined attributes, as well as FDA’s cutting-edge analytical capabilities to fully characterize these materials. As part of the collaboration, Sutro and the Office of Pharmaceutical Quality within the FDA Center for Drug Evaluation and Research will jointly lead the study design and selection of target antigens, payload-linkers, and drug conjugation sites representative of both approved ADCs and those in development. The results will be published upon completion, and the insights gained from this collaboration are expected to enhance OPQ’s ongoing research efforts aimed at bolstering the FDA’s capacity for the analytical characterization of ADCs to enhance ADC quality assessments.