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Patricia Van Arnum was executive editor of Pharmaceutical Technology.
Novartis (Basel, Switzerland) will build a cell culture-derived influenza vaccines manufacturing plant in Holly Springs, North Carolina. Construction is expected to begin in 2007.
Novartis (Basel, Switzerland, www.novartis.com) will build a cellculture-derived influenza vaccines manufacturing plant in HollySprings, North Carolina. Construction is expected to begin in 2007.
Novartis will invest $600 million in the facility, which includes a$220-million award from the US Department of Health and Human Services(Washington, DC, www.hhs.gov).Novartis also is making additional investments at its Marburg, Germanysite to expand capacity for cell culture-derived influenza production.
In announcing its investment plans, Novartis reported that it hadsubmitted a marketing application for cell culture-derived influenzavaccine to European regulatory authorities, specifically the Committeefor Medicinal Products for Human Use of the European Medicines Agency(London, www.emea.eu.int).Novartis says it is seeking to become the first company to commerciallyproduce and market a cell culture-derived influenza vaccines for theEuropean market.
"We are taking the lead in moving flu cell culture vaccinemanufacturing closer to a commercial reality now that the site for a USmanufacturing plant has been chosen and the first EU submission forcell culture vaccine have been completed," said Daniel Vasell, chairmanand CEO of Novartis, in a company release.
Once completed and approved for production, the planned Holly Springssite is expected to produce up to 50 million doses of seasonaltrivalent flu vaccines, which will be for use in the United States. Inthe event of influenza pandemic, the site is planned to have a capacityas much as 150 million monovalent doses annually within six months of apandemic declaration, says Novartis.
Novartis says that cell culture technology for vaccine productionoffers advantages over traditional chicken-egg based methods, includingshorter production lead times and improved reliability of supply,issues that are of importance in the event of a influenza pandemic.
US clinical trials for the cell culture-derived influenza vaccines,which began in 2005, are ongoing. The vaccines for the EU and USclinical trials have been produced at Novartis' site in Marburg, wherethe product was developed