Semin Hematol. 2020 Apr;57(2):33-38. doi: 10.1053/j.seminhematol.2020.07.005. Epub 2020 Jul 27.
Whether as a cure or bridge to transplant, chimeric antigen receptor (CAR)-T cell therapies have shown dramatic outcomes for the treatment of hematologic malignancies, and particularly relapsed/refractory B cell leukemia and lymphoma. However, these therapies are not effective for all patients, and are not without toxicities. The challenge now is to optimize these products and their manufacture. The manufacturing process is complex and subject to numerous variabilities at each step. These variabilities can affect the critical quality attributes of the final product, and this can ultimately impact clinical outcomes. This review will focus on optimizing the manufacturing variables that can impact the safety, purity, potency, consistency and durability of CAR-T cells.
嵌合抗原受体 (CAR)-T 细胞疗法作为一种治疗血液系统恶性肿瘤的方法，尤其是治疗复发/难治性 B 细胞白血病和淋巴瘤，已经取得了显著的疗效。然而，这些疗法并非对所有患者都有效，并且并非没有毒性。现在的挑战是优化这些产品及其制造工艺。制造过程复杂，每个步骤都存在许多变量。这些变量会影响最终产品的关键质量属性，从而最终影响临床结果。本文将重点讨论优化可影响 CAR-T 细胞安全性、纯度、效力、一致性和耐久性的制造变量。
