ORIGINAL RESEARCH
Evaluation of methods of avian leukemia virus inactivation in production of influenza vaccines
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
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.
- EMA/CHMP/BWP/310834/2012 Rev.1 Committee for Medicinal Products for Human use (CHMP) Guideline on Influenza vaccines — Quality module, 2017.
- Rekomendacii po proizvodstvu i kontrolyu vakciny protiv grippa inaktivirovannoj, Prilozhenie 3 serii texnicheskix dokladov VOZ # 927, 2005. Russian.
- Sabbaghi A, Miri SM, Keshavarz M, Zargar M, Ghaemi A. Inactivation methods for whole influenza vaccine production. Rev Med Virol. 2019; 29 (6): e2074.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Rukovodstvo po issledovaniyu validacii virusnoj ochistki: proektirovanie, vklad i interpretaciya issledovanij, ispol'zuyushhix inaktivaciyu i udalenie virusov, EMA CPMP/BWP/268/95, 1996. Russian.
- Freshni RYa. Kul'tura zhivotnyx kletok: prakticheskoe rukovodstvo. Per. 5-go angl. izd. M.: BINOM. Laboratoriya znanij, 2018; 691 s. Russian.
- 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.
- Zavala, Guillermo, Sunny Cheng. Detection and Characterization of Avian Leukosis Virus in Marek’s Disease Vaccines. Avian Diseases. 2006; 50 (2): 209–15.
- Haussmann C, Hauschild F, Jobst B, Novartis AG. Improvements in preparation of influenza virus vaccine antigens. Патент США № US6986808P. 18.03.2008.
- 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.
- 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.