Specificity of Good Manufacturing Practice (GMP) for Biomedical Cell Products
- 作者: Tulina M.1, Pyatigorskaya N.1
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隶属关系:
- Institute of Pharmacy and Translational Medicine, I. M. Sechenov First Moscow State Medical University, Ministry of Health of the Russian Federation
- 期: 卷 164, 编号 4 (2018)
- 页面: 579-582
- 栏目: Translated from Kletochnye Tekhnologii v Biologii i Meditsine (Cell Technologies in Biology and Medicine)
- URL: https://journals.rcsi.science/0007-4888/article/view/239763
- DOI: https://doi.org/10.1007/s10517-018-4035-8
- ID: 239763
如何引用文章
详细
The article describes special aspects of Good Manufacturing Practice (GMP) for biomedical cell products (BMCP) that imply high standards of aseptics throughout the entire productio process, strict requirements to donors and to the procedure of biomaterial isolation, guaranty of tracing BMCP products, defining processing procedures which allow to identify BMCP as minimally manipulated; continuous quality control and automation of the control process at all stages of manufacturing, which will ensure product release simultaneously with completion of technological operations.
作者简介
M. Tulina
Institute of Pharmacy and Translational Medicine, I. M. Sechenov First Moscow State Medical University, Ministry of Health of the Russian Federation
编辑信件的主要联系方式.
Email: mari_bel_90@mail.ru
俄罗斯联邦, Moscow
N. Pyatigorskaya
Institute of Pharmacy and Translational Medicine, I. M. Sechenov First Moscow State Medical University, Ministry of Health of the Russian Federation
Email: mari_bel_90@mail.ru
俄罗斯联邦, Moscow