Use of Cytogenetic Analysis Methods for Assessing the Quality of Cell Lines in Biomedical Cell Products
Biomedical cell products (BMCPs) are a new group of biologicals that are based on various cell lines and are used in the treatment of a wide range of diseases as well as in the field of regenerative medicine. The quality control of the cellular component in such preparations is very important at...
| Main Authors: | , |
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| Format: | Article |
| Language: | Russian |
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Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»
2018-03-01
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| Series: | Биопрепараты: Профилактика, диагностика, лечение |
| Subjects: | |
| Online Access: | https://www.biopreparations.ru/jour/article/view/118 |
| Summary: | Biomedical cell products (BMCPs) are a new group of biologicals that are based on various cell lines and are used in the treatment of a wide range of diseases as well as in the field of regenerative medicine. The quality control of the cellular component in such preparations is very important at all stages of BMCPs development and production. Much attention should be given to confirmation of BMCPs safety because of their specific properties and potential side effects, including the risk of cancer development. Carcinogenesis may be attributed to genetic instability of the BMCP cellular component. A number of cytogenetic methods can be used at the chromosomal level in order to identify the genetic instability of cells in a BMCP. Confirmation of the normal karyotype of cells and identification of various chromosomal abnormalities can be achieved using both classic cytogenetic analysis methods, such as chromosome banding, and molecular cytogenetic methods based on the use of fluorescent in situ hybridization. Combination of these methods may provide a reliable estimation of genetic stability of the cell line in a BMCP, and indirect evidence of absence of malignancy. |
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| ISSN: | 2221-996X 2619-1156 |