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

这个i-Corps项目的更广泛的影响/商业潜力是开发一个基于模拟的决策支持平台，以帮助再生药物制造商，包括细胞、基因和组织工程产品。拟议的技术旨在解决再生医学产品制造和分销面临的挑战。目标是帮助制造商在整个制造过程中及早发现问题。拟议的平台可能会改善获取机会，提高产品质量，降低成本，这可能会使数百万晚期疾病患者以及需要组织和器官移植的人受益。这个i-Corps项目基于开发一个模拟平台，为再生药物制造商提供决策支持。该模拟平台旨在创建单个制造设施或整个大区域制造网络的数字孪生兄弟。该平台结合了两种类型的制造模式：针对患者的、针对自体产品的个性化制造工艺和针对同种异体产品的批量制造工艺。该平台使制造商能够设计系统级的决策，以改进设施设计，并预测“如果”情况，以计划意外的中断。拟议的技术可能会通过解决广泛的挑战来增强再生医学制造、供应链、监管和决策科学领域的知识。建议的技术可能有助于确保制造和分销过程中的准确性、可靠性和及时性。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。

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.