ARMI BioIndustries

ARMI BioIndustries is the full-service development, manufacturing and commercialization operation for the Advanced Regenerative Manufacturing Institute. We provide developers of engineered cells, tissues and organs a comprehensive range of services covering process development, deep tissue and material characterization, clinical manufacturing, regulatory and commercial support. ARMI BioIndustries leverages BioFabUSA’s Tissue Foundry concept, a 30,000-square-feet, state-of-the-art development center, and the extensive experience and expertise of ARMI’s scientists and engineers to enable the scalable, consistent and cost-effective manufacturing of engineered cells, tissues and organs.

Analytical Services

Deep cell and tissue characterization is essential to the development of controlled manufacturing processes for living, cell-based products. ARMI built a Deep Tissue Characterization Center (DTCC) to address this critical need. The DTCC applies a multiomic approach to characterizing cells, tissues, organs and materials. It correlates clinical outcomes to quality attributes and process parameters. And it applies Quality by Design principles to the development of scalable, consistent processes.

Process Development Services

We offer process development specifically designed to meet the needs of regenerative manufacturing. The work conducted by this group is supported by our Deep Tissue Characterization Center, as well as our Tissue Foundry platform. It prioritizes process gaps analysis, simplification, optimization and eventual automation.

Manufacturing Services

Producing the tissue-engineered, clinical trial material following a phase-appropriate, Quality-Management System.

Regulatory Services

We offer regulatory consulting services to support our member organizations with preclinical study design, FDA submissions and interactions and clinical trial design to support existing industries and grow new ones.

Contact one of our experts

BioFabUSA, a program of ARMI, is a public-private partnership with more than 170 members, including companies, academic institutions and not-for profit organizations.




Learn more about work underway to build the biofabrication ecosystem and accelerate the science of regenerative medicine.