ARMI Heathtech Hub

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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.

Technology

ARMI

Initiatives

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