Standardization criteria of cell preparation for clinical use
Using of different cell preparations is an essential part of treatment of many diseases. Production technology and quality control of these products are actually biotechnology research with a variety of the necessary criteria. Quality control system in Russia is missing, so the authors attempt to an...
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Online Access: | https://oncohematology.abvpress.ru/ongm/article/view/17 |
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doaj-f94d4c9229b04777910504665535d6452021-07-29T09:03:03ZrusABV-pressOnkogematologiâ1818-83462014-07-0184374510.17650/1818-8346-2013-8-4-128-13632Standardization criteria of cell preparation for clinical useA. Yu. Ustyugov0E. Yu. Osipova1S. A. Rumyantsev2Dmitry Rogachev Federal Research Center of Pediatric Hematology, Oncology and Immunology, Ministry of Health of Russia N.N. Pirogov Russian National Research Medical University, Ministry of Health of RussiaDmitry Rogachev Federal Research Center of Pediatric Hematology, Oncology and Immunology, Ministry of Health of Russia Moscow Institute of Physics and Technology, Ministry of Education and ScienceDmitry Rogachev Federal Research Center of Pediatric Hematology, Oncology and Immunology, Ministry of Health of Russia N.N. Pirogov Russian National Research Medical University, Ministry of Health of Russia Moscow Institute of Physics and Technology, Ministry of Education and ScienceUsing of different cell preparations is an essential part of treatment of many diseases. Production technology and quality control of these products are actually biotechnology research with a variety of the necessary criteria. Quality control system in Russia is missing, so the authors attempt to analyze and adapt FDA and EU criteria for quality control GMP-producing cell preparations. The developed methodology has been tested on cell preparations of allogeneic and autologous mesenchymal stem cells undergoing ex vivo expansion for clinical use in a number of experimental therapeutic programs in pediatric hematologic malignancies.https://oncohematology.abvpress.ru/ongm/article/view/17cell preparationsmesenchymal stem cellsex vivo expansion |
collection |
DOAJ |
language |
Russian |
format |
Article |
sources |
DOAJ |
author |
A. Yu. Ustyugov E. Yu. Osipova S. A. Rumyantsev |
spellingShingle |
A. Yu. Ustyugov E. Yu. Osipova S. A. Rumyantsev Standardization criteria of cell preparation for clinical use Onkogematologiâ cell preparations mesenchymal stem cells ex vivo expansion |
author_facet |
A. Yu. Ustyugov E. Yu. Osipova S. A. Rumyantsev |
author_sort |
A. Yu. Ustyugov |
title |
Standardization criteria of cell preparation for clinical use |
title_short |
Standardization criteria of cell preparation for clinical use |
title_full |
Standardization criteria of cell preparation for clinical use |
title_fullStr |
Standardization criteria of cell preparation for clinical use |
title_full_unstemmed |
Standardization criteria of cell preparation for clinical use |
title_sort |
standardization criteria of cell preparation for clinical use |
publisher |
ABV-press |
series |
Onkogematologiâ |
issn |
1818-8346 |
publishDate |
2014-07-01 |
description |
Using of different cell preparations is an essential part of treatment of many diseases. Production technology and quality control of these products are actually biotechnology research with a variety of the necessary criteria. Quality control system in Russia is missing, so the authors attempt to analyze and adapt FDA and EU criteria for quality control GMP-producing cell preparations. The developed methodology has been tested on cell preparations of allogeneic and autologous mesenchymal stem cells undergoing ex vivo expansion for clinical use in a number of experimental therapeutic programs in pediatric hematologic malignancies. |
topic |
cell preparations mesenchymal stem cells ex vivo expansion |
url |
https://oncohematology.abvpress.ru/ongm/article/view/17 |
work_keys_str_mv |
AT ayuustyugov standardizationcriteriaofcellpreparationforclinicaluse AT eyuosipova standardizationcriteriaofcellpreparationforclinicaluse AT sarumyantsev standardizationcriteriaofcellpreparationforclinicaluse |
_version_ |
1721249692308733952 |