Development of a Pilot Technology for Cell-Based Anti-Influenza Live Attenuated Pandemic Vaccine Manufacturing

Автор: 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.

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