以嵌合抗原受体基因修饰T淋巴细胞（CAR-T细胞）为代表的免疫细胞治疗产品已经在白血病等血液瘤中取得了重 大进步。细胞治疗产品的生产原材料种类多样，成分复杂，其中基因修饰载体和其他一些赋予细胞特定功能或影响其质量的原 材料通常为关键原材料。这些关键原材料往往会对细胞治疗产品的质量属性和体内疗效产生重要的影响，因此是细胞治疗产品 审评的重要关注点。本文论述了细胞治疗产品中常用的几种关键原材料（包括慢病毒载体和γ-逆转录病毒载体、CRISPR/Cas编 辑系统、转座子系统、分选磁珠和滋养细胞），提出了目前的审评考虑和风险控制策略，以期促进此类产品的临床转化和应用。

Immunotherapy products, represented by chimeric antigen receptor-modified T lymphocytes (CAR-T cells), have achieved significant progress in hematologic malignancies such as leukemia. The raw materials used in the production of cell therapy products are diverse and complex, with gene modification vectors and other raw materials that endow cells with specific functionalities or influence their qualities usually classified as crucial raw materials. These crucial raw materials often have significant impacts on the quality attributes and in vivo efficacy of cell therapy products, making them important concerns in the evaluation of cell therapy products. This article summarizes several crucial raw materials that are commonly used in cell therapy products (including lentiviral vectors and γ-retroviral vectors, CRISPR/Cas gene editing system, transposon system, immunomagnetic separation beads, and feeder layer cells) and proposes the current evaluation considerations and risk control strategies with the aim of advancing the clinical transformation and application of such products.