首页|一种新型细胞智造产线与人工制备对比

一种新型细胞智造产线与人工制备对比

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针对人工制备细胞效率低、成本高及产品批间差异大等缺点,该研究开发了一种新型的人源性脐带间充质干细胞(hUC-MSCs)智造产线,并对比了其与传统人工制备所得细胞的基本特性、安全性及有效性.结果显示,智造产线制备的hUC-MSCs呈纤维状,细胞表面标志物均符合国际细胞与基因治疗协会中定义的间充质干细胞的要求;细胞无菌、支原体结果均呈阴性,内毒素含量低于0.5 EU/mL;癌基因、抑癌基因和核型分析结果正常,端粒酶表达为低活性,异常毒性结果正常;所得细胞的活率高于90%,具有良好的成骨、成脂、成软骨能力,对Th1、Th2、Th17细胞的增殖呈抑制作用,对Treg细胞的增殖则有促进作用.该细胞智造产线制备的hUC-MSCs与人工制备的相比,无显著差异且符合质量标准;并且,在细胞均一性、产能提升、成本优化和部署优越性等方面更有优势,为实现细胞的规模化和产业化制备提供了新思路.
Comparison between a New Type of Cell Intelligent Manufacturing Line and Manual Preparation
To address the shortcomings of low efficiency,high cost and large batch-to-batch variation of manually prepared cells,this study developed a novel smart production line for human umbilical cord mesenchymal stem cells(hUC-MSCs),and compared the basic cell characteristics,safety and efficacy of the obtained cells with those of traditional manually prepared cells.The results showed that the hUC-MSCs prepared by the smart production line were fibrous,and the cell surface markers met the requirements of MSCs defined by the International Society for Cell & Gene Therapy.The results of cell sterility and mycoplasma were negative,and the content of endotoxin was lower than 0.5 EU/mL.The results of oncogenes,oncogenes suppressor and karyotyping analyses were normal.The expression of telomerase was in low activity.The results of abnormal toxicity were normal.The cell viability was higher than 90%.And the strong capabilities of osteogenesis,adipogenesis and chondrogenesis were observed under the microscope.And the cells could inhibit the proliferation of Th1,Th2 and Th17 cells and promote the proliferation of Treg cells.The hUC-MSCs prepared by this production line met the quality standards and showed no significant difference compared with those prepared manually.In conclusion,the cell intelligent production line developed in this study is more advantageous in terms of cell homogeneity,capacity enhancement,cost optimization and superiority of deployment,which provides a new idea to realize the scale-up and industrialization of cell preparation.

mesenchymal stem cellcell intelligent manufacturing lineautomationcapacity enhancement

钟桂强、张芬、王清芳、梁晓、刘沐芸

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深圳市北科生物科技有限公司,广东深圳 518061

细胞产业关键共性技术国家工程研究中心,广东深圳 518061

间充质干细胞 细胞智造产线 自动化 产能提升

细胞产业关键共性技术国家工程研究中心建设项目哈尔滨市细胞制剂数字化智能化生产线开发和推广应用项目

发改高技[2023]447号哈松发改函[2023]79号

2024

中国医药工业杂志
上海医药工业研究院,中国化学制药工业协会

中国医药工业杂志

CSTPCD
影响因子:0.487
ISSN:1001-8255
年,卷(期):2024.55(7)