A new fully closed automated banking process for healthy autologous cells to standardize the starting material for CAR T manufacturing.

Diseases, aging, and pharmacological interventions can all cause severe damage to human cellular functions. Cell therapy has become one of the most promising therapeutic approaches, and the preservation of healthy cells offers unlimited possibilities for disease treatment. While current biobanks fail to meet cell therapy requirements for starting materials, and allogeneic chimeric antigen receptor T (CAR T) cells using healthy donor cells faces immune compatibility challenges. The strategy of banking one's own cells during healthy states for future autologous cell therapy presents a promising alternative. Thus, we engineered the Baize Xin system-a fully closed, automated, good manufacturing practice (GMP)-compliant healthy autologous cell biobank system. It meets the standards for cell therapy starting materials, with a 27% increase in efficiency and a 50% reduction in cost. Moreover, it has been validated across multiple therapeutic manufacturing processes: (1) Clinical-grade CAR T cells via non-viral electroporation achieved >95% viability, 96.20 ± 0.68-fold expansion, and 36.88% ± 4.14% CAR positivity; (2) Cryopreserved and fresh leukapheresis materials show functional equivalency in generating CAR T cells; (3) Non-genetically edited activated T cells over 14 days maintained >95% viability, >200-fold expansion, and approached 100% CD3+ T cell purity. Critically, the resulting standardized cellular materials comply with China's National Medical Products Administration (NMPA) regulatory requirements (acceptance number CXSL2200605). This achievement represents a comprehensive advancement over existing biobanking technologies, providing pharmaceutical companies with a source of regulatory-compliant cellular materials for future therapies. It thereby offers a validated strategy to overcome key limitations in patient-derived autologous cell therapy.