The Department of Health and Human Services Food and Drug Administration awarded a definitive contract valued at $82.2 million to the Massachusetts Institute of Technology under Broad Agency Announcement FY22 FDA BAA for Advanced Research and Development of Regulatory Science. The contract supports the development of an integrated continuous cGMP facility for mRNA manufacturing to address the solicitation's goal of advancing regulatory science tools and approaches for safety and quality evaluations. Major subcontracts were issued to Rensselaer Polytechnic Institute for a new mRNA manufacture process and Arranta Bio Ma LLC for research on rapid mRNA vaccine production methods. Performance will take place in Cambridge, Massachusetts through September 2025. No set aside designation was specified. This award furthers the FDA's efforts to strengthen regulatory frameworks and modernize product assessments through advanced research.
Generated 12/29/23, 3:06 PM