I-Corps: Simulation-based Decision Support Platform for Regenerative Medicine Manufacturing and Distribution

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The broader impact/commercial potential of this I-Corps project is the development of a simulation-based decision-support platform to assist regenerative medicine manufacturers, including cell, gene, and tissue-engineered products. The proposed technology aims to address the challenges facing the manufacturing and distribution in regenerative medicine products. The goal is to assist manufacturers in the identification of problems early on and throughout the overall manufacturing process. The proposed platform may lead to improved access, improved quality of the product, and reduced costs, which may benefit the millions of people suffering from terminal diseases as well as those in need of tissue and organ transplants.This I-Corps project is based on the development of a simulation platform to provide decision support for regenerative medicine manufacturers. The simulation platform is designed to create digital twins of a single manufacturing facility or a manufacturing network throughout a large region. The platform incorporates two types of manufacturing modes: a patient-specific, personalized manufacturing process for autologous products and a batch manufacturing process for allogeneic products. The platform enables manufacturers to devise system-level decisions to improve facility design and predicts “what if” scenarios to plan for unexpected disruptions. The proposed technology may enhance knowledge in regenerative medicine manufacturing, supply chain, regulatory, and decision science realms by addressing a wide range of challenges. The proposed technology may help to ensure accuracy, reliability, and timeliness in the manufacturing and distribution processes.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.