BioFabUSA

Advanced Regenerative Manufacturing Institute

Fast Facts

Established	December 2016

Website	armiusa.org

Mission	To develop a highly diverse, competitive, capable and innovative domestic cell, tissue and organ manufacturing ecosystem that will fundamentally change healthcare for chronic disease and traumatic injury; and to build the trained and ready workforce essential for that ecosystem.

Headquarters	Manchester, NH

Consortium Organizer	Advanced Regenerative Manufacturing Institute (ARMI)

Institute Metrics

as of September 2024

168	Member Organizations
*Total Ongoing and Completed Projects*
76	Technology Projects
26	Education and Workforce Development (EWD) Projects
*Education and Workforce Development*
135,620	Participants in EWD Projects or Institute-led EWD Activities from FY20-FY24

Successes

Click here for the latest DoD MII Success Stories.

Project Examples:

Successful manufacturing of bioengineered red blood cells in an austere environment

First-Ever 3D Printed Regenerative Bone Graft Restores Form & Function for Patients

Biofabrication Technician and Advanced Manufacturing Registered Apprenticeship Programs

Decellularized Porcine Heart

Self-Assembled Ligament for ACL and Rotator Cuff Reconstruction

Manufactured Skin

Institute Snapshot

Significant breakthroughs in cell biology, biofabrication, and materials science in the last decade have laid the foundation for scalable manufacturing and commercialization of bioengineered and enabling technologies. BioFabUSA targets the raw material, equipment, measurement, automation, logistics and analytics challenges that hinder scalable, consistent, and cost-effective manufacturing. The development of bioengineered products on an industrial scale enables DoD to save lives on the battlefield, support force readiness, and restore form, function, and quality of life for service members, their families, and the broader public.

BioFabUSA's Tissue Foundry

Institute Capabilities

BioFab Foundry	BioFabUSA developed the first-ever scalable, modular, automated, and closed manufacturing platform for biofabrication. The original Tissue Foundry (shown above) is composed of a series of subsystems, or modules, each representing a different stage of the manufacturing process for cell-based products. Modularity allows users to scale up and reconfigure the platform to facilitate the manufacture of a broad range of cell-based products; integration of programmable automation allows monitoring and data monitoring of process parameters, opening the door to process control; and automation allows for cost-effective operations at scale. Finally, because the system is closed, the risk of contamination and process variability introduced by exposure to ambient air is mitigated. This eliminates the need for costly capital investments in clean room facilities. Modular, automated and closed manufacturing will ensure Warfighters and the Nation have access to high quality, consistent, and cost-effective cell-based products at industrial scale.
Deep Tissue Characterization Center	The Deep Tissue Characterization Center is an integrated system of analytical instrumentation that supports the in-depth analysis of cell-based products and related components. Characterization, including cell count, multi-omics, and product-specific functional assays is essential for cost-effective development, regulatory advancement, clinical trial results, and production at scale.
Education & Workforce Development	BioFabUSA is building career pathways and training the skilled workforce for the biofabrication industry. By delivering industry-informed, accessible programming to thousands of students, educators, and industry stakeholders each year, BioFabUSA is closing educational skills gaps, speeding job placement, and strengthening the workforce for the defense industrial base. The Institute engages K-12 students in project-based learning, provides U.S. Department of Labor-approved Registered Apprenticeship Programs for biofabrication technicians and advanced manufacturing technicians, and convenes industry and academic partners to develop higher education curriculum that scales delivery and leads directly into biofabrication careers.