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<article article-type="research-article" dtd-version="1.3" xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xml:lang="ru"><front><journal-meta><journal-id journal-id-type="publisher-id">mes</journal-id><journal-title-group><journal-title xml:lang="ru">Экстремальная биомедицина</journal-title><trans-title-group xml:lang="en"><trans-title>Extreme Medicine</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">3033-8964</issn><issn pub-type="epub">3033-8972</issn><publisher><publisher-name>Centre for Strategic Planning of the Federal Medical and Biological Agency</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.47183/mes.2021.032</article-id><article-id custom-type="elpub" pub-id-type="custom">mes-152</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research Article</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="ru"><subject>ОРИГИНАЛЬНОЕ ИССЛЕДОВАНИЕ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>ORIGINAL RESEARCH</subject></subj-group></article-categories><title-group><article-title>Оценка методов инактивирования аденовируса птиц при производстве гриппозных вакцин</article-title><trans-title-group xml:lang="en"><trans-title>Evaluation of avian adenovirus inactivation methods used in the production of influenza vaccines</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Савина</surname><given-names>Н. Н.</given-names></name><name name-style="western" xml:lang="en"><surname>Savina</surname><given-names>N. N.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Наталья Николаевна Савина</p><p>ул. Свободы, д. 52, г. Красное Село, г. Санкт-Петербург, 198320</p></bio><bio xml:lang="en"><p>Natalya N. Savina</p><p>Svobody, 52, Krasnoye Selo, Saint Petersburg, 198320</p></bio><email xlink:type="simple">n.n.savina@spbniivs.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Екимов</surname><given-names>А. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Ekimov</surname><given-names>A. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>ул. Свободы, д. 52, г. Красное Село, г. Санкт-Петербург, 198320</p></bio><bio xml:lang="en"><p>Svobody, 52, Krasnoye Selo, Saint Petersburg, 198320</p></bio><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Трухин</surname><given-names>В. П.</given-names></name><name name-style="western" xml:lang="en"><surname>Trukhin</surname><given-names>V. P.</given-names></name></name-alternatives><bio xml:lang="ru"><p>ул. Свободы, д. 52, г. Красное Село, г. Санкт-Петербург, 198320</p></bio><bio xml:lang="en"><p>Svobody, 52, Krasnoye Selo, Saint Petersburg, 198320</p></bio><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Евтушенко</surname><given-names>А. Э.</given-names></name><name name-style="western" xml:lang="en"><surname>Evtushenko</surname><given-names>A. E.</given-names></name></name-alternatives><bio xml:lang="ru"><p>ул. Свободы, д. 52, г. Красное Село, г. Санкт-Петербург, 198320</p></bio><bio xml:lang="en"><p>Svobody, 52, Krasnoye Selo, Saint Petersburg, 198320</p></bio><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Жиренкина</surname><given-names>Е. Н.</given-names></name><name name-style="western" xml:lang="en"><surname>Zhirenkina</surname><given-names>E. N.</given-names></name></name-alternatives><bio xml:lang="ru"><p>ул. Свободы, д. 52, г. Красное Село, г. Санкт-Петербург, 198320</p></bio><bio xml:lang="en"><p>Svobody, 52, Krasnoye Selo, Saint Petersburg, 198320</p></bio><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Синегубова</surname><given-names>Е. О.</given-names></name><name name-style="western" xml:lang="en"><surname>Sinegubova</surname><given-names>E. O.</given-names></name></name-alternatives><bio xml:lang="ru"><p>ул. Свободы, д. 52, г. Красное Село, г. Санкт-Петербург, 198320</p></bio><bio xml:lang="en"><p>Svobody, 52, Krasnoye Selo, Saint Petersburg, 198320</p></bio><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Слита</surname><given-names>А. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Slita</surname><given-names>A. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>ул. Свободы, д. 52, г. Красное Село, г. Санкт-Петербург, 198320М</p></bio><bio xml:lang="en"><p>Svobody, 52, Krasnoye Selo, Saint Petersburg, 198320</p></bio><xref ref-type="aff" rid="aff-2"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>Санкт-Петербургский научно-исследовательский институт вакцин и сывороток и предприятие по производству бактерийных препаратов Федерального медико-биологического агентства</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Saint Petersburg Research Institute of Vaccines and Serums</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-2"><aff xml:lang="ru"><institution>Санкт-Петербургский научно-исследовательский институт эпидемиологии и микробиологии имени Пастера</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Saint Petersburg Pasteur Research Institute of Epidemiology and Microbiology</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2021</year></pub-date><pub-date pub-type="epub"><day>26</day><month>10</month><year>2024</year></pub-date><volume>23</volume><issue>3</issue><fpage>84</fpage><lpage>89</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Савина Н.Н., Екимов А.А., Трухин В.П., Евтушенко А.Э., Жиренкина Е.Н., Синегубова Е.О., Слита А.В., 2024</copyright-statement><copyright-year>2024</copyright-year><copyright-holder xml:lang="ru">Савина Н.Н., Екимов А.А., Трухин В.П., Евтушенко А.Э., Жиренкина Е.Н., Синегубова Е.О., Слита А.В.</copyright-holder><copyright-holder xml:lang="en">Savina N.N., Ekimov A.A., Trukhin V.P., Evtushenko A.E., Zhirenkina E.N., Sinegubova E.O., Slita A.V.</copyright-holder><license xml:lang="ru" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>Данная работа распространяется под лицензией Creative Commons Attribution 4.0.</license-p></license><license xml:lang="en" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>This work is licensed under a Creative Commons Attribution 4.0 License.</license-p></license></permissions><self-uri xlink:href="https://www.extrememedicine.ru/jour/article/view/152">https://www.extrememedicine.ru/jour/article/view/152</self-uri><abstract><p>При производстве инактивированных гриппозных вакцин на стадии инактивации должен быть инактивирован как вирус гриппа, так и возможные вирусные контаминанты (например, аденовирус птиц), которые могут попасть в вакцину из сырья (куриных эмбрионов). Инактиваторы должны обеспечивать гарантированное снижение вирусной нагрузки контаминанта не менее чем на 4 lg (БОЕ)/мл, что обеспечит его отсутствие в готовой вакцине. Целью работы было выбрать клеточную линию для наработки аденовируса и оценить снижение титра аденовируса в полупродуктах гриппозных вакцин при воздействии инактиваторов. Были подобраны оптимальные условия наработки аденовируса птиц штаммов CELO и Fontes в культуре клеток, в качестве оптимальной выбрана культура клеток Vero; рассмотрены основные используемые инактиваторы: β-пропиолактон и УФ-излучение. Титры аденовируса определяли методом бляшкообразования. Спустя 10 ч инактивации β-пропиолактоном аденовирус штамма CELO показал снижение вирусной нагрузки на 4,12 ± 0,06 lg, а аденовирус штамма Fontes — на 4,20 ± 0,19 lg, что указывает на эффективное действие β-пропиолактона при инактивации. Проведение инактивации УФ-излучением позволяет снизить вирусную нагрузку штамма CELO на 4,69 ± 0,89 lg, а штамма Fontes — на 4,44 ± 1,06 lg за 5 мин. Отмечено, что добавление детергента на стадии расщепления также снижает вирусную нагрузку на 0,93 ± 0,15 lg и 1,04 ± 0,12 lg для штаммов CELO и Fontes соответственно при использовании н-октил-β-D-глюкопиранозида и на 1,18 ± 0,17 lg и 1,12 ± 0,38 lg при использовании тетрадецилтриметиламмоний бромида.</p></abstract><trans-abstract xml:lang="en"><p>Inactivation of influenza virus and other potential contaminants like avian adenoviruses coming from embryonated chicken eggs is a critical step in the production of inactivated influenza vaccines. Inactivation must lead to a guaranteed reduction in contaminant titers by at least 4 lg (PFU)/ml. The aim of this study was to identify an optimum cell line for adenovirus propagation and to estimate a reduction in adenovirus titers in vaccine intermediates after inactivation. In a series of experiments, we identified the optimum conditions and the optimum cell line for the propagation of avian adenovirus (strains CELO and Fontes). The most commonly used inactivation methods were analyzed, including inactivation by β-propiolactone and UV light. Viral titers were measured by plaque assays. After 10 h of inactivation with β-propiolactone, CELO titers fell by 4.12 ± 0.06 lg, whereas Fontes titers, by 4.20 ± 0.19 lg, suggesting that β-propiolactone is an effective inactivating agent. Exposure to UV light led to a reduction in CELO titers by 4.69 ± 0.89 lg and a reduction in Fontes titers by 4.44 ± 1.06 lg after 5 min. N-octyl-β-D-glucopyranoside added at the splitting step reduced CELO titers by 0.93 ± 0.15 lg and Fontes titers by 1.04 ± 0.12 lg, whereas tetradecyltrimethylammonium bromide led to a reduction in CELO and Fontes titers by 1.18 ± 0.17 lg and 1.12 ± 0.38 lg, respectively.</p></trans-abstract><kwd-group xml:lang="ru"><kwd>гриппозные вакцины</kwd><kwd>инактивация</kwd><kwd>аденовирус птиц</kwd><kwd>пропиолактон</kwd><kwd>УФ-излучение</kwd></kwd-group><kwd-group xml:lang="en"><kwd>influenza vaccine</kwd><kwd>inactivation</kwd><kwd>avian adenovirus</kwd><kwd>propiolactone</kwd><kwd>UV radiation</kwd></kwd-group></article-meta></front><back><ref-list><title>References</title><ref id="cit1"><label>1</label><citation-alternatives><mixed-citation xml:lang="ru">Guideline on Influenza vaccines — Quality module. EMA/CHMP/BWP/310834/2012 Rev.1 Committee for Medicinal Products for Human use (CHMP), 2017. 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