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中华临床实验室管理电子杂志 ›› 2019, Vol. 07 ›› Issue (03) : 173 -179. doi: 10.3877/cma.j.issn.2095-5820.2019.03.010

所属专题: 文献

质量控制

临床用细胞培养实验室质量控制
孙巍群1, 陈锦阳1, 刘军权2,()   
  1. 1. 310053 杭州,浙江卫未生物医药科技有限公司
    2. 310053 杭州,浙江卫未生物医药科技有限公司;310053 杭州金域医学检验所有限公司
  • 收稿日期:2018-10-15 出版日期:2019-08-28
  • 通信作者: 刘军权

Quality control of clinical cell culture laboratory

Weiqun Sun1, Jinyang Chen1, Junquan Liu2,()   

  1. 1. Zhejiang Weiwei Biomedical Science and Technology Co., Ltd, Hangzhou 310053, China
    2. Zhejiang Weiwei Biomedical Science and Technology Co., Ltd, Hangzhou 310053, China; Hangzhou Kingmed Medical Laboratory Co., Ltd, Hangzhou 310053, China
  • Received:2018-10-15 Published:2019-08-28
  • Corresponding author: Junquan Liu
  • About author:
    Corresponding author: Liu Junquan, Email:
引用本文:

孙巍群, 陈锦阳, 刘军权. 临床用细胞培养实验室质量控制[J]. 中华临床实验室管理电子杂志, 2019, 07(03): 173-179.

Weiqun Sun, Jinyang Chen, Junquan Liu. Quality control of clinical cell culture laboratory[J]. Chinese Journal of Clinical Laboratory Management(Electronic Edition), 2019, 07(03): 173-179.

随着生物治疗技术发展,细胞制品也成为某些重大难治性疾病治疗的新亮点。由于细胞在临床应用之前须经实验室培养和扩增,每个相关环节都需要明确质量标准。本文根据细胞培养制剂产品特点,提出细胞培养实验室质量控制思路,从细胞生产质量管理规范、细胞制剂产品生产用辅助材料、制备工艺与过程控制、细胞质量控制等方面系统阐述,通过不断完善的质量管理推进细胞产业有序健康发展。

With the development of biotherapeutic technology, cell products have become a new bright spot in the treatment of some major refractory diseases. Since cells need to be cultured and amplified in the laboratory prior to clinical application, quality standards should be defined in every relevant link. According to the characteristics of cell culture preparation products, this paper puts forward the quality control ideas of cell culture laboratory. It systematically expounds the quality control criteria of cell production, auxiliary materials for cell preparation products, preparation process control and cell quality control. Through continuous improvement of quality management, cell industry can be promoted and the order develops healthily.

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