Sutro Biopharma Partners with FDA to Advance Antibody Drug Conjugate Regulatory Standards

Sutro Biopharma, Inc., a company specializing in next-generation antibody drug conjugates (ADCs), has announced a new collaboration with the U.S. Food and Drug Administration (FDA) to develop reference materials aimed at improving regulatory standards and analytical methods for ADC drug development.

The partnership will utilize Sutro’s cell-free XpressCF technology, which allows for precise engineering of ADCs with predefined attributes, combined with the FDA’s advanced analytical capabilities to thoroughly characterize these materials. This joint effort seeks to support enhanced quality control and regulatory evaluation of ADCs, a rapidly growing class of biopharmaceuticals.

Hans-Peter Gerber, Ph.D., Sutro’s Chief Scientific Officer, highlighted the significance of the collaboration, stating that it underscores the flexibility of Sutro’s platform in driving ADC innovation and helping to shape future regulatory standards benefiting the entire industry and patients alike.

Together with the FDA’s Office of Pharmaceutical Quality (OPQ) within the Center for Drug Evaluation and Research (CDER), Sutro will co-lead the design of studies selecting target antigens, payload-linkers, and drug conjugation sites reflecting both approved and in-development ADCs. Findings from the collaboration will be published and are expected to strengthen the FDA’s capacity for analytical characterization and quality assessment of ADCs moving forward.