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Chitra Sethi, Managing Editor, BioPharm International
The Swiss pharmaceutical company Novartis has opened a new vaccine manufacturing facility in Holly Springs, NC.
The Swiss pharmaceutical company Novartis has opened a new vaccine manufacturing facility in Holly Springs, NC. The plant, which is designed to supply 150 million doses of pandemic vaccine within six months of an influenza pandemic declaration, is the first large-scale flu cell culture vaccine and adjuvant manufacturing facility in the US.
The 430,000 sq. ft. facility is a result of a partnership between Novartis and the US Department of Health and Human Services (HHS). The total investment in the facility is nearly $1 billion, through a partnership between Novartis and HHS to support the design, construction, validation, and licensing of the plant.
If licensed in an emergency, the facility will be ready to respond to a pandemic as early as 2011. The plant is planned to be running at full-scale commercial production in 2013.
The facility also can start producing MF59, Novartis’s proprietary adjuvant, as early as December 2009. MF59 is licensed for use in Europe for Novartis’s cell culture-based Influenza A (H1N1) vaccine, Celtura.
Other companies, such as Baxter and Protein Sciences Corporation, are also developing influenza vaccines in cell culture for both pandemic and seasonal flu. The current outbreak of the H1N1 swine flu has accelerated interest in applying cell culture to influenza vaccine production.