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- Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ:STRO), an oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), today announced that it has entered into a collaboration with the U.S. Food and Drug Administration (FDA) 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 (OPQ) within the FDA Center for Drug Evaluation and Research (CDER) 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.
Posted In: STRO
