Henn, Alicia D.

Limited scalability and restricted affordability impede the equitable deployment of curative models of care despite advances achieved with regenerative medicine therapeutics. Mitigating the risk of widening health disparities mandates actions that would improve the availability and accessibility of new classes of biotherapeutics. Namely, the use of Smart Manufacturing empowered by artificial intelligence to increase therapeutic production capacity while reducing cost is an emerging strategy central to the future of the regenerative care economy. Establishing an efficient and effective biomanufacturing ecosystem is essential to building regenerative pipelines into broadly available regenerative therapeutics options. This ecosystem must provide not only necessary cell environment controls and computer process power, but also the sensing technologies to feed critical process parameters to the algorithms in real-time. Here we outline key elements that are in development to support Smart Biomanufacturing, such as machine learning, advanced analytics, digital twins, and modular cytocentric production. The aim of integrating these technologies is to drive down costs, improve access to new regenerative medicine therapeutics, address regulatory science expectations, and in doing so, improve health equity.