Cryo‑processed leukapheresis using automated closed system: a high‑quality starting material for autologous and allogeneic CAR‑T cell therapy manufacturing
Cell & Gene Therapy Insights 2026; 12(6), 623–641
DOI: 10.18609/cgti.2026.074
CAR‑T cell therapy has revolutionized the treatment of hematologic malignancies, but associated manufacturing presents logistical and clinical challenges that can impact product quality while limiting scalability and equitable patient access. Cryo‑processing of starting material is enabling greater manufacturing flexibility and scheduling, critical for global CAR‑T therapy deployment. This study reinforces the utility of cryopreserved leukapheresis as a reliable starting material for autologous and allogeneic CAR‑T cell therapy manufacturing while introducing a novel, automated closed process for generating cryopreserved leukapheresis, which reduces operator‑dependent variability and improves process reproducibility. The automated approach preserves cell viability and phenotype post‑thaw, ensuring minimal impact on T cell subsets, activation potential, exhaustion, memory phenotypes, and cytotoxic function upon CAR‑T manufacturing. This study highlights that combining automation with cryopreservation enables a consistent, GMP‑compliant workflow, reinforcing their role as essential technologies for scalable, decentralized CAR‑T cell manufacturing and supporting the broader adoption of standardized, accessible cell therapy solutions.