Regulatory standards for ADC development

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Sutro Biopharma Announces Research Collaboration with the FDA to Advance Regulatory Standards for Antibody Drug Conjugates
Globenewswireยท 2025-07-22 12:00
Core Insights - Sutro Biopharma has entered a collaboration with the FDA to develop reference materials aimed at improving regulatory standards and analytical methods for antibody drug conjugates (ADCs) [1][2] - The collaboration will utilize Sutro's cell-free XpressCF technology to engineer ADCs with specific attributes, enhancing the FDA's analytical capabilities for ADC characterization [1][2] Company Overview - Sutro Biopharma focuses on the discovery and development of precisely designed cancer therapeutics, leveraging its cell-free XpressCF technology to improve patient outcomes [3] - The company is advancing a robust early-stage pipeline of novel exatecan and dual-payload ADCs, supported by high-value collaborations and industry partnerships [3]