浅析细胞治疗产品中滋养细胞的使用及控制策略

Analysis of the Use and Control Strategies of Feeder Layer Cells in Cell Therapy Products

滋养细胞因能促进目的细胞的扩增效率,已被应用于自然杀伤细胞、肿瘤浸润淋巴细胞等的体外扩增。滋养细胞的来源及改造具有多样性,本文以基因编辑的人慢性髓系白血病细胞(K562细胞)为例,总结了细胞系来源的滋养细胞特点和最新研究进展,并围绕滋养细胞的作用、起始细胞、工程细胞株的构建和建库、生产工艺、质量研究和质量控制、滋养细胞的使用和控制策略等方面提出了药学审评考虑和讨论,以期为业界和监管机构交流探讨提供参考与思路,促进此类产品的临床转化和应用。

Feeder layer cells have been used in the in vitro expansion of NK cells,TIL cells,etc.,since they can promote the expansion efficiency of target cells.Trophoblast cells originate from diverse sources and undergo various modifications.Taking genetically edited K562 cells as an example,this paper summarizes the characteristics and latest research progress of feeder layer cells,focusing on their function,cell origin,construction of engineered cell lines and cell bank,production process,quality research and quality control,and strategies for their use and control.The CMC evaluation considerations and discussions are presented to provide references and insights for the industry and regulatory agencies,expecting to promote the clinical transformation and application of such products.