A review of production technologies for ... - World Health Organization

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Influenza vaccine production technologies 20 December 2006 8 Live-attenuated influenza vaccines: cell-culture-based manufacture. ............... 23 8.1 Introduction................................................................................................................. 23 8.2 LAIV production in cell-culture: summary................................................................... 23 9 Production of influenza vaccines in chicken-embryo fibroblasts....................... 24 9.1 Introduction................................................................................................................. 24 9.2 Laboratory scale ......................................................................................................... 24 9.2.1 Manufacturing process and resource required ...........................................................24 9.3 Industrial scale............................................................................................................ 24 9.3.1 Manufacturing process ...............................................................................................24 9.3.2 Resource required......................................................................................................24 9.4 LAIV production in CEFs; summary ........................................................................... 24 9.4.1 General considerations...............................................................................................24 9.4.2 Advantages ................................................................................................................25 9.4.3 Disadvantages............................................................................................................25 9.4.4 Outstanding issues and questions..............................................................................25 10 Conclusions .............................................................................................................. 25 10.1 Egg-based manufacture of IIV ............................................................................... 27 10.2 Cell-culture-based manufacture of IIV.................................................................... 27 10.3 Egg-based manufacture of LAIV ............................................................................ 27 10.4 Action points and next steps .................................................................................. 28 11 References................................................................................................................. 29 Page 4 of 34
Influenza vaccine production technologies 20 December 2006 1 Acronyms and abbreviations BPL ..................................................................................................................betapropriolactone BSL .........................................................................................................................biosafety level ca ..............................................................................................................................cold adapted CEF.......................................................................................................chicken embryo fibroblast CTL ...........................................................................................................cytotoxic T lymphocyte CAIV ............................................................................................cold-adapted influenza vaccine CPMP .................................................................. Committee for Proprietary Medicinal Products EMEA...............................................European Agency for the Evaluation of Medicinal Products EPI .................................................................................Expanded Programme on Immunization FDA.....................................................................................Food and Drug Administration (USA) GMP.................................................................................................good manufacturing practice HA.......................................................................................... haemagglutinin (of influenza virus) HAI..........................................................................................haemagglutinin-inhibiting antibody IIV.................................................................................................... inactivated influenza vaccine IN ..................................................................................................................................intra nasal IP.................................................................................................................... intellectual property LAIV .......................................................................................... live attenuated influenza vaccine MDCK ........................................................................................Madin Darby canine kidney cells moi ............................................................................................................. multiplicity of infection MVA ...................................................................................................... modified vaccinia Ankara NA........................................................................................... neuraminidase (of influenza virus) NIBSC............................................. National Institute for Biological Standards and Control (UK) OPV ...................................................................................................................oral polio vaccine pfu.................................................................................................................plaque-forming units QA..................................................................................................................... quality assurance QC........................................................................................................................... quality control SPF............................................................................................................ specific pathogen free TC ............................................................................................................................ tissue culture ts .................................................................................................................temperature sensitive WHO ................................................................................................... World Health Organization Page 5 of 34
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