GMP-Compliant T-Cell Manufacturing Process Development

The contract involves the development and refinement of a clinical-grade manufacturing process for A11 HERV-E T cells, focusing on achieving scalability, reproducibility, and full compliance with FDA current Good Manufacturing Practices (cGMP) standards. This subcontract aims to ensure that the manufacturing method can consistently produce high-quality T cells suitable for clinical applications, addressing critical regulatory requirements and facilitating potential therapeutic use. Issued by the National Institutes of Health under the Department of Health and Human Services, the work will be performed in Bethesda, with a solicitation posted in mid-May 2026 and a response deadline in early June 2026. The project falls under the NAICS code 325412, which pertains to pharmaceutical preparation manufacturing. The effort is part of a broader initiative to advance cell therapy manufacturing capabilities within a regulated framework, supporting innovation in biomedical treatment development.