國家衛生研究院 NHRI:Item 3990099045/8399
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    題名: Performance characteristics of qualified cell lines for isolation and propagation of influenza viruses for vaccine manufacturing
    作者: Donis, RO;Ziegler, T;Chen, IM;Davis, CT;Foust, A;Hossain, MJ;Johnson, A;Klimov, A;Loughlin, R;Xu, X;Tsai, T;Blayer, S;Trusheim, H;Colegate, T;Fox, J;Taylor, B;Hussain, A;Barr, I;Baas, C;Louwerens, J;Geuns, E;Lee, MS;Venhuizen, L;Neumeier, E
    貢獻者: Division of Infectious Diseases
    摘要: Cell culture is now available as a method for the production of influenza vaccines in addition to eggs. In accordance with currently accepted practice, viruses recommended as candidates for vaccine manufacture are isolated and propagated exclusively in hens' eggs prior to distribution to manufacturers. Candidate vaccine viruses isolated in cell culture are not available to support vaccine manufacturing in mammalian cell bioreactors so egg-derived viruses have to be used. Recently influenza A (H3N2) viruses have been difficult to isolate directly in eggs. As mitigation against this difficulty, and the possibility of no suitable egg-isolated candidate viruses being available, it is proposed to consider using mammalian cell lines for primary isolation of influenza viruses as candidates for vaccine production in egg and cell platforms.To investigate this possibility, we tested the antigenic stability of viruses isolated and propagated in cell lines qualified for influenza vaccine manufacture and subsequently investigated antigen yields of such viruses in these cell lines at pilot-scale. Twenty influenza A and B-positive, original clinical specimens were inoculated in three MDCK cell lines. The antigenicity of recovered viruses was tested by hemagglutination inhibition using ferret sera against contemporary vaccine viruses and the amino acid sequences of the hemagglutinin and neuraminidase were determined. MDCK cell lines proved to be highly sensitive for virus isolation. Compared to the virus sequenced from the original specimen, viruses passaged three times in the MDCK lines showed up to 2 amino acid changes in the hemagglutinin. Antigenic stability was also established by hemagglutination inhibition titers comparable to those of the corresponding reference virus. Viruses isolated in any of the three MDCK lines grew reasonably well but variably in three MDCK cells and in VERO cells at pilot-scale. These results indicate that influenza viruses isolated in vaccine certified cell lines may well qualify for use in vaccine production.
    日期: 2014-11-12
    關聯: Vaccine. 2014 Nov 12;32(48):6583-6590.
    Link to: http://dx.doi.org/10.1016/j.vaccine.2014.06.045
    JIF/Ranking 2023: http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=0264-410X&DestApp=IC2JCR
    Cited Times(WOS): https://www.webofscience.com/wos/woscc/full-record/WOS:000345469000040
    Cited Times(Scopus): http://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=84908568634
    顯示於類別:[李敏西] 期刊論文

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