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  1. Innovative Technologies

BioFoundry: A Scalable, Modular, Automated and Closed Medical Product Manufacturing System

Principal Collaborator: Advanced Regenerative Manufacturing Institute (ARMI)
Project Start Date: October 2024

Project Description: Academia, industry, medicine, and government have recognized for decades the power of regenerative medicine technologies to improve health outcomes for the more than 60% of Americans living with chronic illness or traumatic injury. However, even the most promising technologies have fallen short of their envisioned impact due to fragmentation between disciplines, as well as manual and inconsistent manufacturing approaches. The proposed BioFoundry project will install a scalable, modular, automated and closed (SMAC) medical products manufacturing platform at the FDA I-TEAM Hub, enabling FDA reviewers, investigators, and policy makers to advance regulatory science by testing numerous scenarios in a pre-competitive setting, develop metrics or other criteria that can be used to advance Agency strategies, and guide industry on effective development.

Extensive use of inline sensors for various measures - such as product characteristics, metabolic indicators of culture growth, and sterility testing throughout the automated process, coupled with current state of the art data science, enables a quality systems approach incorporating quality by design (QbD) and process analytical technology (PAT) principles. This maximizes flexibility of production methods and products while optimizing yield and minimizing the need for manual manipulation. The generalizability and modularity of the BioFoundry platform allows it to accommodate explorations of novel tools and techniques of any biotech product where cell culture is an inherent part of the manufacturing system, including, e.g., red blood cells, recombinant proteins, monoclonals and gene therapies. 

Project Goal: ARMI proposes to install and operationalize a Biofoundry in the I-TEAM Hub to accommodate the study of cell culture-based manufacturing of medical products, including: “traditional” cell therapies; a range of protein-based products such as monoclonals, recombinant proteins, and extracellular matrices; gene therapies; and tissue engineered products. The first case study will be the expansion of induced Pluripotent Stem Cells (iPSCs) which can be used as a platform for studying control of growth and differentiation in a cell type that, although not a medical product, represents a cutting-edge source technology from which numerous potential medical products are being developed.

Contact the Office of Regulatory and Emerging Science: ORES@fda.hhs.gov

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