Laurel, MD –
BioFabUSA, a Department of Defense (DoD) Manufacturing Innovation Institute (MII) operating under the DoD Manufacturing Technology Program (DoD ManTech), successfully showcased the world’s first fully automated BioFoundry during a walkthrough demonstration at the FDA’s I-TEAMS facility. This groundbreaking biomanufacturing hub, designed with modularity and scalability, represents a major leap forward in producing cell, tissue, and organ therapies with unmatched efficiency.
The BioFoundry platform, installed at the FDA facility in January, is poised to revolutionize combat casualty care by enabling the production of biomedical products closer to the point of need. This innovation addresses critical vulnerabilities in the military’s medical supply chain, ensuring faster and more effective treatments for warfighters in remote and contested environments. During the walkthrough, senior leaders, including Mr. Michael Holthe, Principal Deputy to the Assistant Secretary of War for Science and Technology (PDASD(S&T)), and senior representatives for the Department of Commerce and the Defense Health Agency, gained direct insight into how this cutting-edge infrastructure strengthens military readiness and resilience.
The demonstration highlighted the BioFoundry’s adherence to four core manufacturing principles—Scalable, Modular, Automated, and Closed (SMAC)—which collectively define next-generation biomedical manufacturing systems. Participants observed live system components and physical assets that showcased the platform’s ability to deliver speed, resilience, and regulatory confidence. The hands-on, station-based format encouraged interaction and conversation, offering a unique perspective on the future of biomanufacturing.
“The success of BioFabUSA’s BioFoundry demonstrates the transformative power of our DoD Manufacturing Innovation Institutes in addressing critical challenges, such as ensuring the availability of life-saving biomedical products closer to the point of need,” said Keith DeVries, director of DoD ManTech. “This groundbreaking achievement, incorporating proven manufacturing principles into the emerging field of regenerative medicine, highlights the importance of collaboration across government, industry, and academia to strengthen our defense industrial base and enhance military readiness."
This event underscored the DoD’s commitment to advancing critical technologies that enhance military lethality and readiness. By leveraging AI-enabled, automated manufacturing approaches, the BioFoundry platform strengthens the resilience of the military’s medical supply chain and facilitates inter-agency collaboration with stakeholders from the FDA, Commerce, and Health and Human Services Departments.
For more information, visit the DoD ManTech website.