Cryo-processed Leukapheresis Using Automated Closed System: A High-Quality Starting Material For Autologous And Allogeneic CAR-T Cell Therapy Manufacturing

By Yu Zhang, Matteo Rossi, Gabin Fonkou Tchinda, Gautier Delwiche, Romain Robert, Apolline Fossion, Stephanie Borensztein, Michael Iweinsde Wavrans, Celine Jacques-Hespel, Caroline Lonez, Eytan Breman, Dominic Clarke and Alexandre Michaux

Selecting and handling leukapheresis starting material is a critical decision in CAR‑T cell therapy manufacturing, particularly as programs scale and become more distributed. This poster examines whether cryopreserved leukapheresis processed through an automated, closed workflow can reliably replace fresh material without compromising outcomes. Using matched donor samples, cryo‑processed and fresh leukapheresis were directly compared across key manufacturing parameters. Results show that automated cryo‑processing maintains high cell viability, recovery, and lymphocyte composition through wash, formulation, thaw, and culture steps. CAR‑T cells produced from cryopreserved starting material demonstrated comparable expansion, transduction efficiency, phenotype, activation, and exhaustion marker profiles. Functional assessments further confirmed preserved cytokine secretion and robust cytotoxic activity, with cryo‑derived material performing at least as well as fresh inputs. By reducing operator‑dependent variability and enabling standardized, GMP‑aligned workflows, the study supports cryo‑processed leukapheresis as a dependable foundation for flexible, scalable CAR‑T manufacturing across autologous and allogeneic applications.