Use of Cytogenetic Analysis Methods for Assessing the Quality of Cell Lines in Biomedical Cell Products
https://doi.org/10.30895/2221-996X-2018-18-1-25-32
Abstract
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.
About the Authors
O. A. Rachinskaya
Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation
Russian Federation
Russian Federation
1st Professional Category Expert of the Laboratory of Biomedical Cell Products of the Testing Centre for Evaluation of Medicinal Products’ Quality. Candidate of Biological Sciences
8/2 Petrovsky boulevard, Moscow 127051, Russian Federation
V. A. Merkulov
Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation
Russian Federation
Russian Federation
Deputy Director-General for Medicinal Products’ Evaluation. Doctor of Medical Sciences, Professor
8/2 Petrovsky boulevard, Moscow 127051, Russian Federation
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For citations:
Rachinskaya O.A., Merkulov V.A. Use of Cytogenetic Analysis Methods for Assessing the Quality of Cell Lines in Biomedical Cell Products. BIOpreparations. Prevention, Diagnosis, Treatment. 2018;18(1):25-32. (In Russ.) https://doi.org/10.30895/2221-996X-2018-18-1-25-32
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