biopreparatБИОпрепараты. Профилактика, диагностика, лечениеBiological Products. Prevention, Diagnosis, Treatment2221-996X2619-1156Scientific Centre for Expert Evaluation of Medicinal Productsbiopreparat-6Research ArticleОРИГИНАЛЬНЫЕ СТАТЬИORIGINAL ARTICLESВалидация XTT-теста для оценки антипролиферативной активности препаратов на основе моноклональных антителValidation of the XTT-test for assessing the antiproliferative activity of biologics on the basis of monoclonal antibodiesЛягоскинИ. В.LyagoskinI. V.Lyagoskin@ibcgenerium.ruБерестовойМ. А.BerestovoyM. A.noemail@neicon.ruПотеряевД. А.PoteryaevD. A.noemail@neicon.ruЗейналоваЭ. С.ZeinalovaE. S.noemail@neicon.ruВишневскийА. Ю.VishnevskiyA. Yu.noemail@neicon.ruКазаровА. А.KazarovA. A.noemail@neicon.ruOOO Международный биотехнологический центр «Генериум»РоссияInternational Biotechnological Center «Generium»Russian Federation201520022018014550Copyright © Лягоскин И.В., Берестовой М.А., Потеряев Д.А., Зейналова Э.С., Вишневский А.Ю., Казаров А.А., 20182018Лягоскин И.В., Берестовой М.А., Потеряев Д.А., Зейналова Э.С., Вишневский А.Ю., Казаров А.А.Lyagoskin I.V., Berestovoy M.A., Poteryaev D.A., Zeinalova E.S., Vishnevskiy A.Y., Kazarov A.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/6

Методика оценки антипролиферативной активности препаратов моноклональных антител с применением соли те-тразолия XTT отработана на примере препарата Герцептин™ («Roche»). Метод основан на спектрометрическом анализе уровня формазана, трансформированного живыми клетками из водорастворимой тетразоливой соли ХТТ. Уровень формазана пропорционален количеству жизнеспособных клеток. Методика была валидирована по показателям: специфичность, линейность, правильность и прецизионность.

Using the example of Herceptin (Roche) a method of assessing the antiproliferative activity of monoclonal antibodies using tetrazolium salt was developed. The method is based on spectrometric measurement of the level of formazan transformed by living cells from a water soluble salt XTT. The level of formazan is proportional to the number of viable cells. The technique was in terms of specificity, calibration curve, accuracy and precision.

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