切换至 "中华医学电子期刊资源库"

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/OL]. 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/OL]. 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.

1
Garry GA, Garry DJ. Somatic cell therapy for chronic heart failure: in search of mechanistic insights[J]. J Card Fail, 2015,21(7):583-585.
2
Kamigaki T, Ibe H, Okada S, et al. Improvement of impaired immunological status of patients with various types of advanced cancers by autologous immune cell therapy[J]. Anticancer Res, 2015, 35(8):4535-4543.
3
Zhang B, Chen H. Quality management and outcome evaluation of cellular immunotherapy of cancer[J]. Chin J Cancer Biotherap, 2015, 22(1):8-15.
4
Mount NM, Ward SJ, Kefalas P, et al. Cell-based therapy technology classifications and translational challenges[J]. Philos Trans R Soc Lond B Biol Sci, 2015,370(1680):20150017.
5
Spohn G, Wiercinska E, Karpova D, et al. Automated CD34+ cell isolation of peripheral blood stem cell apheresis product[J]. Cytotherapy, 2015,17(10):1465-1471.
6
Huang W. Discussion on aseptic operation technique in sterile preparation[J]. Doctor, 2018(Z1):279-282.
7
Wang DL. The types safety and efficacity of the transplanted cells[J]. China Biotechnology, 2013,33(9):119-125.
8
Daley GQ, Insoo H, Apperley JF, et al. Setting global standards for stem cell research and clinical translation: the 2016 ISSCR guidelines[J]. Stem Cell Reports, 2016,6(6):787-797.
9
Lim JO. Regulation policy on cell- and tissue-based therapy products in Korea[J]. Tissue Eng Part A, 2015,21(23-24):2791-2796.
10
Setiawati A, Nguyen HT, Jung Y. Future research directions in the design of versatile extracellular matrix in tissue engineering[J]. Int Neurourol J, 2018,22(Suppl 2):S66-75.
11
韩立,惠利健,潘国字. 细胞的命运:间质干细胞的药代动力学[J]. 中国细胞生物学学报, 2018,40(6):857-866.
12
Cheng B, Lu SL, Fu XB. Regenerative medicine in China: main progress in different fields[J]. Mil Med Res, 2016, 3(1):24.
13
Tulina MA, Pyatigorskaya NV. Specificity of good manufacturing practice (GMP) for biomedical cell products[J]. Bull Exp Biol Med, 2018,164(4):579-582.
14
Bredenoord AL, Clevers H, Knoblich JA. Human tissues in a dish: the research and ethical implications of organoid technology[J]. Science, 2017,355(6322):eaaf9414.
15
Uphoff S, Lord ND, Okumus B, et al. Stochastic activation of a DNA damage response causes cell-to-cell mutation rate variation[J]. Science, 2016, 351(6277):1094-1097.
16
Goyal A, Murray JM. Modelling the impact of cell-to-cell transmission in hepatitis B virus[J]. Plos One, 2016,11(8):e0161978.
17
Solomon J, Csontos L, Clarke D, et al. Current perspectives on the use of ancillary materials for the manufacture of cellular therapies[J]. Cytotherapy, 2016,18(1):1-12.
18
Ji ST, Kim H, Yun J,et al. Promising therapeutic strategies for mesenchymal stem cell-based cardiovascular regeneration: from cell priming to tissue engineering[J]. Stem Cells Int, 2017,2017:3945403.
19
Kempf H, Andree B, Zweigerdt R. Large-scale production of human pluripotent stem cell derived cardiomyocytes[J]. Adv Drug Deliv Rev, 2016,96:18-30.
20
刘克斌. 理化实验室质量控制方法[J]. 中国城乡企业卫生, 2016,31(5):51-53.
21
Llobet L, Montoya J, Lópezgallardo E, et al. Side effects of culture media antibiotics on cell differentiation[J]. Tissue Eng Part C Methods, 2015,21(11):1143-1147.
22
Pamies D, Bal-Price A, Simeonov A, et al. Good cell culture practice for stem cells and stem-cell-derived models[J]. ALTEX, 2017, 34(1):95-132.
23
Atouf F. Cell-based therapies formulations: unintended components[J]. AAPS J, 2016,18(4):844-888.
24
Andrews PW, Ben-David U, Benvenisty N, et al. Assessing the safety of human pluripotent stem cells and their derivatives for clinical applications[J]. Stem Cell Reports, 2017,9(1):1-4.
25
Andrews PW, Baker D, Benvinisty N, et al. Points to consider in the development of seed stocks of pluripotent stem cells for clinical applications: International Stem Cell Banking Initiative (ISCBI)[J]. Regen Med, 2015,10(2 suppl):1-44.
26
中国医药生物技术协会. 干细胞制剂制备质量管理自律规范[J]. 中国医药生物技术, 2016,11(6):481-490.
27
Chen C, Cui ZR, Huang ZH. Control strategy for the production of trypsin for injection[J]. Shanghai Med Pharm J, 2018,39(13):87-91.
28
Kamigaki T, Matsuda E, Okada S, et al. Prospective evaluation of safety of immune-cell therapy for patients with various types of advanced cancer[J]. Anticancer Res, 2014,34(8):4601-4607.
29
Brown J, Kudrin A. Switching to biosimilar infliximab (CT-P13): evidence of clinical safety, effectiveness and impact on public health[J]. Biologicals, 2016,44(4):257-266.
30
中国医药生物技术协会. 免疫细胞制剂制备质量管理自律规范[J]. 中国医药生物技术, 2016,11(5):385-393.
31
萧惠来. FDA发布的"改变剂型和改变给药途径药品非临床安全性评价指导原则"介绍[J]. 药物评价研究, 2016,39(2):171-174.
32
Wong J, Jeraj H, Vilar E, et al. Endotoxin detection in end-stage kidney disease[J]. J Clin Pathol, 2015,68(1):73-78.
33
Food and Drug Administration, HHS. Revisions to exceptions applicable to certain human cells, tissues, and cellular and tissue-based products. Final rule[J]. Fed Regist, 2016,81(120):40512-40518.
[1] 罗辉, 方晔. 品管圈在提高甲状腺结节细针穿刺检出率中的应用[J/OL]. 中华医学超声杂志(电子版), 2024, 21(10): 972-977.
[2] 吴禾禾, 马春亮, 常青, 陈宇, 牛丽娟, 王勇. 超声医学质量控制与住院医师规范化培训相结合的实践探讨[J/OL]. 中华医学超声杂志(电子版), 2024, 21(07): 698-701.
[3] 刘畅, 蒋洁, 胥雪冬, 崔立刚, 王淑敏, 陈文. 北京市海淀区医疗机构甲状腺超声检查及TIRADS分类基线调查[J/OL]. 中华医学超声杂志(电子版), 2024, 21(07): 693-697.
[4] 张亚庆, 黄旴宁, 许珊珊, 刘小蓝. 海南省二级与三级医院超声医学质量控制指标分析[J/OL]. 中华医学超声杂志(电子版), 2024, 21(07): 681-685.
[5] 王晓娜, 张宁, 宋伟, 杨明, 李丽, 薛红元. 河北省超声医学质量管理与控制现状分析[J/OL]. 中华医学超声杂志(电子版), 2024, 21(07): 675-680.
[6] 顾莉莉, 姜凡. 安徽省超声产前筛查切面图像质量现状调查情况及分析[J/OL]. 中华医学超声杂志(电子版), 2024, 21(07): 671-674.
[7] 周易, 张红梅, 尹立雪, 杨浩, 付培. 四川省超声医学质量控制指标动态变化趋势分析[J/OL]. 中华医学超声杂志(电子版), 2024, 21(07): 664-670.
[8] 王益佳, 周青, 曹省, 袁芳洁, 周妍, 张梅. 中国经胸超声心动图检查存图及报告质控现状分析[J/OL]. 中华医学超声杂志(电子版), 2024, 21(07): 657-663.
[9] 高琼, 孙终霞, 张戈, 王敏, 徐子杭, 张佳藤, 蒋天安. 超声诊断胰腺占位性病变漏误诊原因及对策分析[J/OL]. 中华医学超声杂志(电子版), 2024, 21(05): 517-521.
[10] 德央, 尼玛玉珍, 苏娜, 普布次仁, 拉姆次仁, 嘎措, 格桑德吉, 姜玉新, 李建初, 王红燕. 西藏自治区超声医学专业质量控制现状分析及对策[J/OL]. 中华医学超声杂志(电子版), 2024, 21(03): 327-330.
[11] 钟雅雯, 王煜, 王海臻, 黄莉萍. 肌苷通过抑制线粒体通透性转换孔开放缓解缺氧/复氧诱导的人绒毛膜滋养层细胞凋亡[J/OL]. 中华妇幼临床医学杂志(电子版), 2024, 20(05): 525-533.
[12] 国家人体捐献器官获取质量控制中心, 中华医学会器官移植学分会, 中国医师协会器官移植医师分会, 中国医院协会器官获取与分配工作委员会, 中国器官移植发展基金会. 中国器官捐献五年提升计划[J/OL]. 中华移植杂志(电子版), 2024, 18(05): 275-277.
[13] 嵇振岭, 陈杰, 唐健雄. 重视复杂腹壁疝手术并发症的预防和处理[J/OL]. 中华疝和腹壁外科杂志(电子版), 2024, 18(06): 601-606.
[14] 邱英鹏, 李欣雨, 邱海波, 刘松桥, 张凌, 于湘友, 秦秉玉, 蒲莹莹, 赵佳钰, 刘永军, 肖月, 杨毅. 连续性肾脏替代治疗质量控制指标体系的建立及验证[J/OL]. 中华重症医学电子杂志, 2024, 10(04): 351-357.
[15] 罗文英, 邱丽红, 刘慧, 戴家泽. 基于问题的学习教学模式在“检验分析前质量控制”劳动教育中的实践研究[J/OL]. 中华临床实验室管理电子杂志, 2024, 12(04): 244-250.
阅读次数
全文


摘要


AI


AI小编
你好!我是《中华医学电子期刊资源库》AI小编,有什么可以帮您的吗?