biopreparatБИОпрепараты. Профилактика, диагностика, лечениеBiological Products. Prevention, Diagnosis, Treatment2221-996X2619-1156Scientific Centre for Expert Evaluation of Medicinal Products10.30895/2221-996X-2018-18-1-25-32biopreparat-118Research ArticleОБЗОРЫREVIEWSПрименение методов цитогенетического анализа при оценке качества клеточных линий в составе биомедицинских клеточных продуктовUse of Cytogenetic Analysis Methods for Assessing the Quality of Cell Lines in Biomedical Cell ProductsРачинскаяО. А.RachinskayaO. A.

Эксперт 1 категории лаборатории биомедицинских клеточных продуктов Испытательного центра экспертизы качества лекарственных средств, канд. биол. наук

Российская Федерация, 127051, Москва, Петровский бульвар, д. 8, стр. 2

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

Rachinskaya@expmed.ruМеркуловВ. А.MerkulovV. A.

Заместитель генерального директора по экспертизе лекарственных средств, д-р  мед. наук, профессор

Российская Федерация, 127051, Москва, Петровский бульвар, д. 8, стр. 2

Deputy Director-General for Medicinal Products’ Evaluation. Doctor of Medical Sciences, Professor

8/2 Petrovsky boulevard, Moscow 127051, Russian Federation

Федеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской ФедерацииРоссияFederal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian FederationRussian Federation2018260320181812532Copyright © Рачинская О.А., Меркулов В.А., 20182018Рачинская О.А., Меркулов В.А.Rachinskaya O.A., Merkulov V.A.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.biopreparations.ru/jour/article/view/118

Биомедицинские клеточные продукты (БМКП) — новая группа препаратов, основанных на применении клеточных линий различного происхождения для лечения широкого спектра  заболеваний, в том числе в сфере регенеративной медицины. Контроль качества клеточного компонента таких препаратов является важной задачей на всех стадиях разработки и производства БМКП. Большое внимание должно уделяться подтверждению безопасности  препаратов в силу ряда их особенностей и возможности возникновения побочных эффектов  при их применении, в том числе риска развития онкологических заболеваний. Возможной  причиной канцерогенеза может стать генетическая нестабильность клеточного компонента БМКП. Для выявления генетической нестабильности клеток, входящих в состав  БМКП, на хромосомном уровне возможно применение ряда цитогенетических методов.  Подтверждение наличия в клетках неизменного кариотипа и идентификацию различных  хромосомных аномалий возможно осуществлять с помощью как классических  цитогенетических методов анализа, например дифференциальное окрашивание хромосом, так и с помощью молекулярно-цитогенетических методов, основанных на применении флуоресцентной гибридизации in situ. При комплексном использовании этих  методов возможно получение достоверной оценки генетической стабильности и косвенного  доказательства отсутствия малигнизации клеточной линии в составе БМКП.

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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The authors declare that there are no conflicts of interest present.