Scale-up and delivery of allogeneic cell therapies to large patient populations
Cell & Gene Therapy Insights 2023; 9(6), 523–535
Cell therapy has become a therapeutic reality for many patients, with several successful autologous drug approvals over the last few years. Beyond the known off-the-shelf benefits provided, allogeneic cell therapy cost structure makes this technology substantially more economical, increasing the ability of cell therapy to treat large patient populations. As allogeneic cell therapy continues its exponential growth, a scale-appropriate model to start clinical trials early, while aiding a smooth transition into large scale when the need comes, will be required for companies to successfully deliver from first-in-human to commercialization. This article will explore how the use of outstanding technology, alongside a tried-and-tested standardized systematic approach and reliable analytics, can enable the delivery of a robust and commercially viable process; ensuring an adequate supply to achieve therapeutic and commercial goals.