[摘要] 嵌合抗原受体T（chimeric antigen receptor T, CAR-T）细胞疗法因在血液肿瘤中的突出疗效已成为肿瘤细胞免疫治疗领域中新的研发热点。作为CAR-T 细胞生产关键原材料的病毒载体，在CAR基因结构设计、生产工艺的精细化、质量控制和标准的设定等方面与CAR-T细胞产品的安全性、有效性和质量的可控性密切相关。本文根据慢病毒和γ-逆转录病毒载体的研发进展，结合审评体会，对病毒载体研发和生产过程中需要重点关注的几个常见问题进行讨论，希望能为未来国内相关产品的研发、上市提供参考。

[Abstract] Due to the spectacular therapy results in hematologic tumors, chimeric antigen receptor T (CAR-T) cell therapy has been the research hot-spot in the field of cell-immunotherapy. Viral vectors, as the critical raw material in CAR-T cell manufacturing, are closely related to the safety, efficacy and quality control of CAR-T cell products, in the aspects of the structure design of CAR gene, refinement of production process, quality control and setting of characterization and specification etc. Based on the research progress in lentiviral and γ-retroviral vectors development and the evaluation experiences, this paper discusses some common problems that need to be focused on in the preparation of viral vectors, expecting to provide references for the development and the authorization applications of domestic related products in the future.