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Development of a Pilot Technology for Cell-Based Anti-Influenza Live Attenuated Pandemic Vaccine Manufacturing
Development of a Pilot Technology for Cell-Based Anti-Influenza Live Attenuated Pandemic Vaccine ManufacturingАвтор: E.A. Nechaeva, I.F. Radaeva, T.Yu.Sen’kina, N.B. Gerasimenko, M.P. Bogryantseva, R.N. Kostyleva, N.V. Zhilina, T.M. Sviridenko, K.E. Zubareva, N.A. Varaksin, T.G. Ryabicheva, I.V. Kiseleva, N.V.Larionova, and L.G. Rudenko Страница: 23-34
Development of a Pilot Technology for Cell-Based Anti-Influenza Live Attenuated Pandemic Vaccine Manufacturing Russian Journal of Biotechnology, 2013, N 6, P. 23-34 UDC 615.371:578.832.1.012 Section: “Biologicals Technology”
E.A. Nechaeva 1, *, I.F. Radaeva 1, T.Yu.Sen’kina 1, N.B. Gerasimenko 1, M.P. Bogryantseva 1, R.N. Kostyleva 1, N.V. Zhilina 1, T.M. Sviridenko 1, K.E. Zubareva 1, N.A. Varaksin 1, T.G. Ryabicheva 1, I.V. Kiseleva 2, N.V.Larionova 2, and L.G. Rudenko 2 1 The State Research Center of Virology and Biotechnology Vector, 630559, Kol'tsovo, Novosibirskaya oblast Russia 2 The Institute of Experimental Medicine, Russ. Acad. Med.Sci, 197376, St.-Petersburg Russia e-mail: nechaeva@vector.nsc.ru
A technology for the manufacturing of the Vector-Flu cell-based live attenuated pandemic vaccine using the A/H1N1 cold-adapted influenza strain has been developed. A certified line of MDCK cells was used as a substrate in accordance with the WHO guidelines. The final vaccine preparation was in the form of an amorphous mass and was easily water-soluble, pH value being 6.90 — 6.94; the potencies of monovalent bulks ranged from 6.33 to 6.80 log10 EID50/0.2 ml. Monovalent bulk release assays (sterility control, control for mycoplasma and extraneous agents, identity test with homologous type specific antiserum and lack of cross-reactivity with heterological antiosera) were successfully passed. The residual cellular DNA in the final vaccine formulation was less than 10 ng/dose. The vaccine preparation was substantially stable, namely, the specific potency losses were not found out at temperatures ranging from 4 to 8°C within a period of 1.5 year. The vaccine batches were controlled by the National Control Institute and subjected to preclinical trials that demonstrated the attenuation and immunogenicity of the preparation.
Key words: A/H1N1 influenza pandemic virus, MDCK cells, Vector-Flu vaccine.
31.03.2015, 1729 просмотров. |
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