性能增强的药物：定向嵌合抗原受体（CAR）细胞的设计与...
Performance-enhancing drugs: design and production of redirected chimeric antigen receptor (CAR) T cells.Performance enhancement of the immune system can now be generated through ex vivo gene modification of T cells in order to redirect native specificity to target tumor antigens. This approach combines the specificity of antibody therapy, the expanded response of cellular therapy and the memory activity of vaccine therapy. Recent clinical trials of chimeric antigen receptor (CAR) T cells directed toward CD19 as a stand-alone therapy have shown sustained complete responses in patients with acute lymphoblastic leukemia and chronic lymphocytic leukemia. As these drug products are individually derived from a patient's own cells, a different manufacturing approach is required for this kind of personalized therapy compared with conventional drugs. Key steps in the CAR T-cell manufacturing process include the selection and activation of isolated T cells, transduction of T cells to express CARs, ex vivo expansion of modified T cells and cryopreservation in infusible media. In this review, the steps involved in isolating, genetically modifying and scaling-out the CAR T cells for use in a clinical setting are described in the context of in-process and release testing and regulatory standards. 性能增强的药物：定向嵌合抗原受体（CAR）细胞的设计与生产能够通过体内基因修饰的T细胞来增强免疫系统的性能，从而能够重定向T细胞靶向肿瘤抗原。这种技术结合了抗体治疗的特异性，细胞治疗的扩大效益和疫苗治疗的记忆能力。最近的靶向CD19的嵌合抗原修饰的T细胞的临床试验显示，对于急性淋巴细胞白血病患者和慢性淋巴白血病患者，具有持续的完全的缓解作用。因为这些药物来自于病人自己的细胞，与传统的药物相比，就需要一个不同的生产途径。CAR-T生产中的关键步骤在于筛选和活化T细胞，转导T细胞使其表达CARs，T细胞的体外扩增以及在介质中的保存。在这篇综述中，涉及到了分离的步骤，基因修饰和CAR-T细胞的扩增以及监管标准。出自爱康得生物技术
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