International Practice of Storing Human Cell Lines Intended for Clinical Use

Currently, the Russian Federation does not have a well-established state-controlled market for cell banks (CB) containing cell material that is potentially applicable for clinical purposes. Cryopreservation of cells in cell bank (CB) is an important step in the production of a number of biomedical c...

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Main Authors: O. A. Rachinskaya, A. A. Chaplenko, E. V. Melnikova, I. S. Semenova, Yu. V. Olefir
Format: Article
Language:Russian
Published: Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» 2018-12-01
Series:Биопрепараты: Профилактика, диагностика, лечение
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Online Access:https://www.biopreparations.ru/jour/article/view/193
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author O. A. Rachinskaya
A. A. Chaplenko
E. V. Melnikova
I. S. Semenova
Yu. V. Olefir
author_facet O. A. Rachinskaya
A. A. Chaplenko
E. V. Melnikova
I. S. Semenova
Yu. V. Olefir
author_sort O. A. Rachinskaya
collection DOAJ
description Currently, the Russian Federation does not have a well-established state-controlled market for cell banks (CB) containing cell material that is potentially applicable for clinical purposes. Cryopreservation of cells in cell bank (CB) is an important step in the production of a number of biomedical cell products and makes it possible to overcome difficulties faced by manufacturers during production and storage of large amounts of cell material. At present there are a large number of human cell lines in the world, which are stored in CB owned by commercial and public organisations in different countries. In addition, new cell lines are being banked every year. All this makes it difficult to find cell material suitable for production purposes or that could potentially be used as donor material in clinics. This study analysed the international practice of storing human cell lines for clinical use. The authors of the study systematised the existing CB worldwide and analysed regulatory documents governing the activities of these banks in different countries. The analysis revealed a trend towards formation of CB, often specialising in certain types of cells, as well as a trend towards creation of registries giving full information about cell lines including data on their scientific application. The increasing development and clinical use of cell therapy products in the Russian Federation and abroad will most likely lead to the increase in the number of CB and registry systems, as well as amounts of materials stored in them, including cell lines intended for clinical use.
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institution Kabale University
issn 2221-996X
2619-1156
language Russian
publishDate 2018-12-01
publisher Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»
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series Биопрепараты: Профилактика, диагностика, лечение
spelling doaj-art-e4a3dd16e8c64efbb342f88b6dbdbc1c2025-08-20T03:59:39ZrusMinistry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»Биопрепараты: Профилактика, диагностика, лечение2221-996X2619-11562018-12-0118421622410.30895/2221-996X-2018-18-4-216-224145International Practice of Storing Human Cell Lines Intended for Clinical UseO. A. Rachinskaya0A. A. Chaplenko1E. V. Melnikova2I. S. Semenova3Yu. V. Olefir4Scientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsCurrently, the Russian Federation does not have a well-established state-controlled market for cell banks (CB) containing cell material that is potentially applicable for clinical purposes. Cryopreservation of cells in cell bank (CB) is an important step in the production of a number of biomedical cell products and makes it possible to overcome difficulties faced by manufacturers during production and storage of large amounts of cell material. At present there are a large number of human cell lines in the world, which are stored in CB owned by commercial and public organisations in different countries. In addition, new cell lines are being banked every year. All this makes it difficult to find cell material suitable for production purposes or that could potentially be used as donor material in clinics. This study analysed the international practice of storing human cell lines for clinical use. The authors of the study systematised the existing CB worldwide and analysed regulatory documents governing the activities of these banks in different countries. The analysis revealed a trend towards formation of CB, often specialising in certain types of cells, as well as a trend towards creation of registries giving full information about cell lines including data on their scientific application. The increasing development and clinical use of cell therapy products in the Russian Federation and abroad will most likely lead to the increase in the number of CB and registry systems, as well as amounts of materials stored in them, including cell lines intended for clinical use.https://www.biopreparations.ru/jour/article/view/193cell linescell bankscell line registriesbiomedical cell productsregenerative medicine
spellingShingle O. A. Rachinskaya
A. A. Chaplenko
E. V. Melnikova
I. S. Semenova
Yu. V. Olefir
International Practice of Storing Human Cell Lines Intended for Clinical Use
Биопрепараты: Профилактика, диагностика, лечение
cell lines
cell banks
cell line registries
biomedical cell products
regenerative medicine
title International Practice of Storing Human Cell Lines Intended for Clinical Use
title_full International Practice of Storing Human Cell Lines Intended for Clinical Use
title_fullStr International Practice of Storing Human Cell Lines Intended for Clinical Use
title_full_unstemmed International Practice of Storing Human Cell Lines Intended for Clinical Use
title_short International Practice of Storing Human Cell Lines Intended for Clinical Use
title_sort international practice of storing human cell lines intended for clinical use
topic cell lines
cell banks
cell line registries
biomedical cell products
regenerative medicine
url https://www.biopreparations.ru/jour/article/view/193
work_keys_str_mv AT oarachinskaya internationalpracticeofstoringhumancelllinesintendedforclinicaluse
AT aachaplenko internationalpracticeofstoringhumancelllinesintendedforclinicaluse
AT evmelnikova internationalpracticeofstoringhumancelllinesintendedforclinicaluse
AT issemenova internationalpracticeofstoringhumancelllinesintendedforclinicaluse
AT yuvolefir internationalpracticeofstoringhumancelllinesintendedforclinicaluse