生物医学研究在制造嵌合抗原受体 T 细胞 (CAR-T) 疗法方面取得了重大进展，标志​​着细胞免疫疗法的变革时代。然而，现有的自体细胞疗法的制造方法仍然面临着成本、免疫细胞来源、安全风险和可扩展性等方面的挑战。这些挑战促使人们最近努力利用自动化封闭系统生物反应器和人工智能创建的模型来优化细胞疗法的工艺开发和制造。与此同时，mRNA、CRISPR 基因组编辑和转座子等非病毒基因转移方法正被应用于改造 T 细胞和其他免疫细胞，如巨噬细胞和自然杀伤细胞。正在开发初级免疫细胞和干细胞的替代来源，以产生通用的同种异体疗法，这标志着当前自体范例的转变。这些制造领域的多方面创新强调了集体努力，推动这种治疗方法在不断发展的癌症治疗领域获得更广泛的临床采用并改善患者的治疗结果。在这里，我们回顾了当前的 CAR 免疫细胞制造策略，并重点介绍了细胞治疗规模化、自动化、工艺开发和工程方面的最新进展。© 2024。作者获得 Springer-Verlag GmbH 德国公司的独家许可，该公司是施普林格自然。

Biomedical research has witnessed significant strides in manufacturing chimeric antigen receptor T cell (CAR-T) therapies, marking a transformative era in cellular immunotherapy. Nevertheless, existing manufacturing methods for autologous cell therapies still pose several challenges related to cost, immune cell source, safety risks, and scalability. These challenges have motivated recent efforts to optimize process development and manufacturing for cell therapies using automated closed-system bioreactors and models created using artificial intelligence. Simultaneously, non-viral gene transfer methods like mRNA, CRISPR genome editing, and transposons are being applied to engineer T cells and other immune cells like macrophages and natural killer cells. Alternative sources of primary immune cells and stem cells are being developed to generate universal, allogeneic therapies, signaling a shift away from the current autologous paradigm. These multifaceted innovations in manufacturing underscore a collective effort to propel this therapeutic approach toward broader clinical adoption and improved patient outcomes in the evolving landscape of cancer treatment. Here, we review current CAR immune cell manufacturing strategies and highlight recent advancements in cell therapy scale-up, automation, process development, and engineering.© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.