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DOI: 10.47183/mes.2022.047
Copyright: © 2022 by the authors. Licensee: Pirogov University.
This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution license (CC BY).

ORIGINAL RESEARCH

Evaluation of methods of avian leukemia virus inactivation in production of influenza vaccines

Savina NN1, Ekimov AA1, Shuklina MA2, Trukhin VP1, Evtushenko AE1, Zhirenkina EN1, Stepanova LA2
About authors

1 St. Petersburg Research Institute of Vaccines and Serums and Bacterial Preparations Production Company of the FMBA of Russia, St. Petersburg, Russia

2 Smorodintsev Research Institute of Influenza, St. Petersburg, Russia

Corresponding author: Alexey Alexandrovich Ekimov
Svobody, 52, Krasnoe Selo, St. Petersburg, 198320, Russia; ur.sviin@vomikeaa

About paper

Author contribution: all authors contributed equally to the research methodology design, data collection, analysis and interpretation, article authoring and editing.

Compliance with the ethical standards: the study was conducted in accordance with the ethical principles of the Declaration of Helsinki of 1964 and its subsequent revisions.

Received: 2022-10-31 Accepted: 2022-11-19 Published online: 2022-12-29
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  1. EMA/CHMP/BWP/310834/2012 Rev.1 Committee for Medicinal Products for Human use (CHMP) Guideline on Influenza vaccines — Quality module, 2017.
  2. Rekomendacii po proizvodstvu i kontrolyu vakciny protiv grippa inaktivirovannoj, Prilozhenie 3 serii texnicheskix dokladov VOZ # 927, 2005. Russian.
  3. Sabbaghi A, Miri SM, Keshavarz M, Zargar M, Ghaemi A. Inactivation methods for whole influenza vaccine production. Rev Med Virol. 2019; 29 (6): e2074.
  4. Savina NN, Ekimov AA, Trukhin VP, Evtushenko AE, Zhirenkina EN, Sinegubova EO. Evaluation of avian adenovirus inactivation methods used in the production of influenza vaccines. Extreme Medecine. 2021; (3): 84–9.
  5. Plotnikov VA, Grebennikova TV, Dudnikova EK, Shulpin MI, Lazareva SP, Nikonova ZB, i dr. O rasprostranenii virusa lejkoza ptic v pticevodcheskix xozyajstvax na territorii Rossii. Sel'skoxozyajstvennaya biologiya. 2013; 6: 36–42. Russian.
  6. Bister K, Varmus HE, Stavnezer E, Hunters E, Vogt PK. Biological and biochemical studies on the inactivation of avian oncoviruses by ultraviolet irradiation. Virology. 1977; 77 (2): 689–704.
  7. Herrera-Rodriguez J, Signorazzi A, Holtrop M, de Vries-Idema J, Huckriede A. Inactivated or damaged? Comparing the effect of inactivation methods on influenza virions to optimize vaccine production. Vaccine. 2019; 37 (12): 1630–7.
  8. Kap M, Arron GI, Loibner M, Hausleitner A, Siaulyte G, Zatloukal K, Riegman P. Inactivation of Influenza A virus, Adenovirus, and Cytomegalovirus with PAXgene Tissue Fixative and Formalin. Biopreservation and Biobanking. 2013; 11 (4): 229–34.
  9. Shuo Lei, Xun Gao, Yang Sun, Xiangyong Yu, Longshan Zhao, Gas chromatography-mass spectrometry method for determination of β-propiolactone in human inactivated rabies vaccine and its hydrolysis analysis, Journal of Pharmaceutical Analysis. 2018; 8 (6): 373–7.
  10. Rukovodstvo po issledovaniyu validacii virusnoj ochistki: proektirovanie, vklad i interpretaciya issledovanij, ispol'zuyushhix inaktivaciyu i udalenie virusov, EMA CPMP/BWP/268/95, 1996. Russian.
  11. Freshni RYa. Kul'tura zhivotnyx kletok: prakticheskoe rukovodstvo. Per. 5-go angl. izd. M.: BINOM. Laboratoriya znanij, 2018; 691 s. Russian.
  12. Li Xue, Dong Xuan, Sun Xiaolong, Li Weihua, Zhao Peng, Cui Zhizhong, Wang Xin. Preparation and immunoprotection of subgroup B avian leukosis virus inactivated vaccine. Vaccine. 2013; 31 (46): 5479–85.
  13. Zavala, Guillermo, Sunny Cheng. Detection and Characterization of Avian Leukosis Virus in Marek’s Disease Vaccines. Avian Diseases. 2006; 50 (2): 209–15.
  14. Haussmann C, Hauschild F, Jobst B, Novartis AG. Improvements in preparation of influenza virus vaccine antigens. Патент США № US6986808P. 18.03.2008.
  15. Burt DS, Jones DH, Lowell GH, White GL, Torossian K, Fries LF. ID Biomedical Corp of Quebec. Proteosome influenza vaccine. Патент США № US18247600P. 15.02.2000.
  16. Truhin VP, Evtushenko AJe, Krasilnikov IV, Savina NN, Bykov DG, Ujba SV, Vasilev AN, Ryskova EV, Nacharova EP, Arakelov SA, avtory. Federal'noe gosudarstvennoe unitarnoe predpriyatie «Sankt-Peterburgskij nauchno-issledovatel'skij institut vakcin i syvorotok i predpriyatie po proizvodstvu bakterijnyx preparatov» Federal'nogo mediko-biologicheskogo agentstva (FGUP SPbNIIVS FMBA Rossii). Sposob polucheniya antigena ili antigenov dlya proizvodstva protivogrippoznoj vakciny i vakcina na ego osnove. Patent RF # RU2019118695A. 14.06.2019. Russian.