Rapid CAR-T cells: accelerating manufacturing to enable fast transition of CAR-T cell therapies to the clinic

CAR-T cell therapies have revolutionized the oncology landscape, leading to unprecedented successes in the clinic. Despite the remarkable progress and vast growth in the number of CAR-T cell programs transitioning into the clinic since the first approvals in 2017, the complex manufacturing processes associated with these therapies present challenges that impact patient accessibility to these potentially curative treatments. The field has begun to explore rapid CAR-T cell manufacturing approaches that enable the generation of products that possess stronger stem-like properties and exhibit robust potency and persistence when challenged in vitro and in vivo. In the clinic, first-in-human trials of rapid-CAR-T cells support these observations, reporting notable anti-tumor responses from dose-level administrations lower than those used for products manufactured under longer-term protocols. In this article, the advantages of shorter CAR-T cell manufacturing protocols and the benefits of automation will be explored. Lonza will introduce a rapid manufacturing application that consolidates, within a 72-hour automated workflow, all critical steps required for transforming T cells into potent CAR-T cell therapies. The phenotypic and functional attributes of rapid CAR-T cell products manufactured in this platform will be described, alongside a cryopreservation strategy to support the recovery of stable, viable, and functional CAR-T cells.