ARMI - Advanced Regenerative Manufacturing Institute 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.

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.