Email this article Specificity of Good Manufacturing Practice (GMP) for Biomedical Cell Products
- Authors: Tulina M.A.1, Pyatigorskaya N.V.1
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Affiliations:
- Institute of Pharmacy and Translational Medicine, I. M. Sechenov First Moscow State Medical University, Ministry of Health of the Russian Federation
- Issue: Vol 164, No 4 (2018)
- Pages: 579-582
- Section: 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
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Abstract
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.
About the authors
M. A. Tulina
Institute of Pharmacy and Translational Medicine, I. M. Sechenov First Moscow State Medical University, Ministry of Health of the Russian Federation
Author for correspondence.
Email: mari_bel_90@mail.ru
Russian Federation, Moscow
N. V. 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
Russian Federation, Moscow
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