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BioFabUSA — Advanced Regenerative Manufacturing Institute

BioFabUSA Fast Facts


Established

December 2016

Website armiusa.org

Mission Make practical the scalable, consistent, and cost-effective manufacturing of cells, tissues, and organs and develop the trained and ready workforce necessary for that manufacturing.

Headquarters Manchester, NH

Consortium Organizer Advanced Regenerative Manufacturing Institute (ARMI)

Institute Metrics as of December 31, 2021

 
163    Member Organizations

Total Committed Funding on Original and Follow-on Agreements with DoD
$80M    Base Federal Funding
$214M    Base Non-Federal Cost Share

Additional Committed Project Funding
$33M    DoD Projects
$6M    Academia/Industry Projects

Total Ongoing and Completed Projects
46    Technology Projects
15    Education and Workforce Development (EWD) Projects

Education and Workforce Development
16,129    Participants in EWD Projects or Institute-led EWD Activities in Fiscal Year (FY) 2021

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 engineered tissues and tissue-related technologies.  BioFabUSA has targeted the raw material, equipment, measurement, automation, logistics and big data analytics challenges that hinder scalable, consistent, and cost-effective manufacturing.  The development of tissue-engineered medical products on an industrial scale enables DoD to accelerate creation of numerous medical products for our wounded warfighters, which support force readiness and save lives on the battlefield.


BioFabUSA's Tissue Foundry

Institute Capabilities

 
BioFab Foundry
BioFabUSA developed the first-ever BioFab Foundry manufacturing platform.  The Tissue Foundry (shown above) is composed of a series of subsystems, or modules, each representing a different stage of the manufacturing process for cells, tissues and organs — from culture of the cells that make up the tissue to packaging of the final product.  Modularity allows users to scale up and reconfigure the platform to facilitate the manufacture of all cells, tissues, and organs.  Integration of programmable automation allows monitoring and data logging of process parameters in the short term, and opens the door to process control through big data analytics, machine learning and artificial intelligence in the long term.  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 significantly.  This eliminates the need for costly capital investments in clean room facilities.  Modular, automated and closed manufacturing will ensure that the warfighter and the nation have access to sufficient numbers of effective, consistent, and affordable cells, tissues and organs.
 
Deep Tissue
Characterization Center

The Deep Tissue Characterization Center is an integrated system of analytical instrumentation that supports the in-depth analysis of cells, culture media, and engineered tissues, including characterization of cell count/viability, apoptosis, multi-omics (e.g., transcriptome, proteome, lipidome, metabolome), and other product-specific functional assays.  This analysis of cells, culture media, and tissues correlates with successful production runs and clinical trial results to determine critical process parameters for the automated control of tissue manufacturing.
 
Education & Workforce
Development

BioFabUSA is working to close educational skills gaps in tissue engineering and organ manufacturing through accessible educational and training opportunities.  Over 5,000 students have already participated in the developed activities.  The kit is “productized” with complete instructions, including a teacher guide and student guide, with questions aligned to the Next Generation Science Standards, Common Core Standards, and the Framework for K-12 Science Education.  These kits provide opportunities to highlight essential manufacturing skills and processes and allow students to envision a career pathway for themselves in this emerging technology area, ultimately attracting the future workforce to the biofabrication industry.  As the industry continues to evolve, BioFabUSA is responding to the growing industry-driven demand and is working to educate the current workforce needed for scalable manufacture of cells, tissues and organs through various Certificate & Training Programs.