Sutro Biopharma Enters into Collaboration with US FDA to Advance Antibody Drug Conjugate Standards
Wednesday, July 23, 2025
Sutro Biopharma has announced a new research collaboration with the United States Food and Drug Administration (FDA) aimed at advancing regulatory standards for antibody drug conjugates (ADCs).
The agreement focuses on the development of reference materials and the improvement of analytical methods used in ADC drug development.
The initiative will combine Sutro’s cell-free XpressCF® technology with the FDA’s advanced analytical expertise. This collaboration is expected to support the creation of precisely engineered ADCs with predefined characteristics, which are critical for quality control and regulatory assessment.
The partnership involves Sutro and the Office of Pharmaceutical Quality (OPQ) within the FDA’s Center for Drug Evaluation and Research (CDER). Together, they will design the study and select specific components such as target antigens, payload-linkers, and drug conjugation sites. These will reflect both existing approved ADCs and those currently in development.
Upon completion, the results of the collaboration will be published. The findings are expected to support the FDA’s ongoing efforts to improve the analytical characterisation of ADCs and enhance regulatory evaluation processes for this growing class of biopharmaceuticals.
Source: sutrobio.com
