由于在治疗选择有限的疾病中显示出良好疗效，自体细胞治疗法近年来受到越来越多的关注。嵌合抗原受体（CAR）T细胞疗法在血液肿瘤学适应症中取得了临床成功，为重症患者提供了可能具有治愈功效的疗法。尽管CAR T细胞等工程细胞疗法为有未满足需求的患者提供了新的选择，高成本和复杂的制造过程可能会阻碍临床和商业的推广。Cocoon平台（来自瑞士巴塞尔的Lonza公司）通过实现高效、功能封闭和自动化生产，无论是在临床还是商业规模上，解决了许多挑战，如高劳动需求、流程一致性、污染风险和可扩展性。该平台可自定义和易于使用，并且需要最少的操作者干预，从而降低了流程的可变性。我们提出了两种过程，展示了Cocoon平台的能力。我们采用不同的T细胞激活方法-OKT3和CD3/CD28 Dynabeads（来自美国马萨诸塞州沃尔瑟姆的Thermo Fisher Scientific公司），生成符合临床CAR T细胞产品的重要质量属性的最终细胞产品。本研究展示了一种制造解决方案，来应对手动制造方法的挑战，并促进自体细胞疗法的规模化。版权所有©2023年国际细胞与基因治疗学会。由Elsevier Inc.发表，版权所有。

Autologous cell-based therapeutics have gained increasing attention in recent years because of their efficacy at treating diseases with limited therapeutic options. Chimeric antigen receptor (CAR) T-cell therapy has demonstrated clinical success in hematologic oncology indications, providing critically ill patients with a potentially curative therapy. Although engineered cell therapies such as CAR T cells provide new options for patients with unmet needs, the high cost and complexity of manufacturing may hinder clinical and commercial translation. The Cocoon Platform (Lonza, Basel, Switzerland) addresses many challenges, such as high labor demand, process consistency, contamination risks and scalability, by enabling efficient, functionally closed and automated production, whether at clinical or commercial scale. This platform is customizable and easy to use and requires minimal operator interaction, thereby decreasing process variability. We present two processes that demonstrate the Cocoon Platform's capabilities. We employed different T-cell activation methods-OKT3 and CD3/CD28 Dynabeads (Thermo Fisher Scientific, Waltham, MA, USA)-to generate final cellular products that meet the critical quality attributes of a clinical autologous CAR T-cell product. This study demonstrates a manufacturing solution for addressing challenges with manual methods of production and facilitating the scale-up of autologous cell therapy.Copyright © 2023 International Society for Cell & Gene Therapy. Published by Elsevier Inc. All rights reserved.