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...

Full description

Bibliographic Details
Main Authors: A. Yu. Ustyugov, E. Yu. Osipova, S. A. Rumyantsev
Format: Article
Language:Russian
Published: ABV-press 2014-07-01
Series:Onkogematologiâ
Subjects:
Online Access:https://oncohematology.abvpress.ru/ongm/article/view/17
id doaj-f94d4c9229b04777910504665535d645
record_format Article
spelling 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