However, to date, no vaccines have been licensed using this technology.Ĭhiron has already submitted “mock-up” dossiers to European Union (EU) regulatory authorities for review and approval of an avian influenza vaccine (currently in clinical trials) and a license application for a cell-culture-based vaccine. The typical cell-culture production process can be run in batch sizes of practical scale, sufficient to provide vaccine quantities for interpandemic periods and pandemics. The cell-culture vaccine process is suitable for large-scale manufacture, and the process parameters can be ramped up and run routinely and cost effectively. The substrates or media for cell-line propagation are not susceptible to virulent virus strains as embryonated chicken eggs are. The critical step is the availability of the seed virus. However, there are no lead times involved, because typical cell-culture processes use cell lines once a cell line is infected with the seed virus in a fermenter, the process can begin. Once the virus is propagated and harvested, the downstream processing parameters for purification, filling, and packaging of the vaccine are similar to current pharmaceutical methodologies and egg-based methodologies.
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