Inactivated influenza vaccines prepared in cell culture : National Institute for Biological Standards and Control, Potters Bar, Herts., U.K. September 26-27, 1997
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Inactivated influenza vaccines prepared in cell culture : National Institute for Biological Standards and Control, Potters Bar, Herts., U.K. September 26-27, 1997
（Developments in biological standardization, v. 98）
Karger, 1999
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Proceedings of a meeting organized and sponsored by the National Institute for Biological Standards and Control (NIBSC) and co-sponsored by the World Health Organization (WHO) and the International Association for Biologicals (IABS)
内容説明・目次
内容説明
Influenza vaccines have been produced in embryonated hens' eggs for over 50 years, but recently there has been considerable effort to develop cell culture systems for vaccine production. This publication reports on a two-day meeting held at the National Institute for Biological Standards and Control. Scientists from many countries involved in the surveillance of influenza viruses and in the manufacture and control of influenza vaccines present their latest findings regarding this new vaccine development. The feasibility and practical advantages of producing a cell-culturederived vaccine are clearly demonstrated, as are the promising results from the initial clinical trials. The main focus of these studies is to make recommendations for future action which should form the basis for collaborative studies and further activities by WHO and regulatory agencies to ensure that cell-culture-derived influenza vaccines are at least equivalent to conventional egg derived vaccines in terms of safety and effectiveness.
目次
- Part 1 Isolation and cultivation of influenza virus on mammalian cells: an overview of host cell selection, J.S. Robertson
- suitability of MDCK cells grown in a serum-free medium for influenza virus production, N. Kessler et al
- production of influenza virus in serum-free mammalian cell cultures, O.W. Merten et al
- growth and immuno-genicity of influenza viruses cultivated in Vero or MDCK cells and in embryonated chicken eggs, E.A. Govorkova
- evaluation of immune responses to inactivated influenza vaccines prepared in embryonated chicken eggs and MDCK cells in a mouse model, K. Nerome et al
- cell culture for surveillance of influenza, M. Zambon. Part 2 Selection of vaccine strains: generation and characteristics of reassortant influenza A viruses propagated in serum-free cultured MDCK-SF1 cells, J.M.T. Voeten et al. Part 3 Scale up for vaccine production: influvac tl- a safe Madin Darby canine kidney (MDCK cell culture based influenza vaccine, R. Brands et al
- development of a vero cell-derived influenza whole virus vaccine, O. Kistner et al. Part 4 Clinical trials: safety, reactogenicity and immunogenicity of Madin Darby canine kidney cell-derived inactivated influenza subunit vaccine - a meta-analysis of clinical studies, A.M. Palache et al
- A phase I, randomised controlled clinical trial to study the reactogenicity and immunogenicity of a new split influenza vaccine derived from a non-tumorigenic cell line, P.B. Percheson et al. Part 5 General regulatory issues I - cell substrates: experience with vero cell at Pasteur Merieux Connaught, B.J. Montagnon et al
- quality assurance for cell substrates, G.N. Stacey, P. Phillips
- WHO requirements for the use of animal cells as in vitro substrates for the production of biologicals - application to influenza vaccine production, E. Griffiths
- ICH guidelines and PhEur monographs on derivation and characterization of cell substrates used for production of biotechnological/biological products, R. Dobbelaerg. Part 6 General regulatory issues II - cell culture influenza vaccines: regulatory perspective in the United States on cell cultures for production of inactivated influenza virus vaccines, R.A. Levandowski
- cell culture influenza vaccine - an Australian perspective, L. Chang et al
- the influence of the host cell on standardization the neuraminidase content of influenza vaccines, L. Gerentes et al.
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