Full speed ahead: how rapid CAR-T manufacturing can shape the cell therapy landscape
Cell & Gene Therapy Insights 2025; 11(4), 515–532
DOI: 10.18609/cgti.2025.062
Autologous CAR-T cell therapy has revolutionized treatment options and improved therapeutic outcomes for B cell leukemia, lymphoma, and multiple myeloma patients worldwide. However, patient access, cost and time to receive their personalized medicine remain a hurdle for many patients waiting to receive a cell therapy. Reducing CAR-T cell manufacturing time is one strategy to shorten the vein-to-vein time, bringing life-saving therapies to patients faster. Beyond expedited access to treatment, an accelerated manufacturing process may also enhance CAR-T cell durability, leading to improved clinical responses. This review highlights current advancements in the rapid cell therapy manufacturing space, while also discussing the challenges to widespread adoption of a rapid process including meeting required clinical doses, the need for development of expedited release assays and quality control procedures. Despite the challenges, adoption of a rapid process holds promise to increase manufacturing capacity and reduce costs to help further improve patient access.