Use of Cytogenetic Analysis Methods for Assessing the Quality of Cell Lines in Biomedical Cell Products

• Main Authors: O. A. Rachinskaya, V. A. Merkulov
• Format: Article
• Language: Russian
• Published: Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» 2018-03-01
• Series: Биопрепараты: Профилактика, диагностика, лечение
• Subjects: biomedical cell product; cell line, genetic instability; chromosomal abnormality; karyotyping
• Online Access: https://www.biopreparations.ru/jour/article/view/118

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.