CAR-T 疗法生产：面向可规模化、可及治疗的方法、质控与创新综述

Chimeric antigen receptor (CAR) T cell therapies have transformed the treatment of hematologic malignancies, providing meaningful clinical outcomes for patients with limited therapeutic options.

However, the complexity of these therapies presents significant manufacturing challenges that could affect cost, scalability, and accessibility. Early CAR T production relied on highly manual, variable processes developed in academic settings, whereas current commercial manufacturing has moved toward more structured and standardized platforms. This review examines how that transition unfolded, with particular attention to changes in process design, analytical control strategies, and quality systems that support more robust manufacturing operations.

Rather than individual technologies, the literature emphasizes increased levels of maturity in process controls as the defining feature of progress in manufacturing. Improvements in unit operations have helped to enable more predictable scale-out of therapies, reinforcing the role of manufacturing in translating scientific innovation into consistent clinical delivery.