Significant breakthroughs in cell biology, biofabrication and materials science in the last decade have laid the foundation for large-scale manufacturing and commercialization of engineered tissues and tissue-related technologies, including tissues- and organs-on-chip. However, the tissue engineering field is fragmented and lacks a mechanism with which to turn laboratory breakthroughs into manufactured products. Therefore, the nation needs an industrial commons, in the form of a Manufacturing Innovation Institute (MII) within the Manufacturing USA network, in which to coalesce the field and provide a route for nascent product concepts to reach the marketplace. Bringing these products to the market will benefit critical U.S. public health needs and will provide the economic drivers needed to create new highly-skilled jobs.
BioFabUSA has been initiated as a ManufacturingUSA (MII) and will be sustained by the Advanced Regenerative Manufacturing Institute (ARMI), a non-profit organization located in Manchester, New Hampshire. ARMI's mission is make practical the large-scale manufacturing of engineered tissues and tissue-related technologies, to benefit existing industries and grow new ones. To that end, the technical scope for BioFabUSA work includes innovations across five thrust areas: (1) Cell Selection, Culture and Scale-up, (2) Biomaterial Selection and Scale-up; (3) Tissue Process Automation and Monitoring; (4) Tissue Maturing Technologies and (5) Tissue Preservation and Transport.
To carry out its mission, BioFabUSA will integrate innovative cell and tissue cultures with advances in biofabrication, automation, robotics, and analytical technologies to create disruptive research and development tools and FDA-compliant volume manufacturing processes.
The overarching goal of BioFabUSA is to establish a public-private partnership that will:
- develop disruptive cell- and tissue-based technologies across five thrust areas,
- produce modular and scalable GMP-compliant manufacturing processes and integrated technologies across technology- (TRL) and manufacturing-readiness levels (MRL) 4-7,
- develop and standardize manufacturing best practices throughout the industry that are aligned with existing and evolving FDA guidance,
- close the skills gap in tissue and organ manufacturing by providing training opportunities to undergraduates, graduates, veterans and non-college bound youth, and
- disseminate knowledge and enabling technologies to encourage continued innovation.
To achieve this goal, BioFabUSA will bring together engineering, life science, computer science, materials science, manufacturing and workforce development expertise from industry, 2- and 4-year community colleges and universities, non-profit organizations, and local, state and federal government. A diverse, multidisciplinary consortium has been established.
ARMI's BioFabUSA receives core funding from the Department of Defense, is part of the ManufacturingUSA network and aims to become self-sustaining by (1) attracting paying members; (2) providing contract development services; (3) providing contract manufacturing services and (4) licensing technologies to its members.