Novartis (NVS) and the U.S. Department of Health and Human Services will invest nearly $1 billion to build the first large cell culture-based flu vaccine manufacturing center in the United States. The new North Carolina manufacturing facility will be capable of producing up to 150 million doses of flu vaccine within 6 months of a pandemic declaration should an emergency warrant it, but not until 2011, Novartis says.
The plant broke ground November 24 and will reach full production scale by 2013. Meanwhile, it will begin producing Novartis’ adjuvanted cell culture-based vaccine, MF59, which is approved in Europe and under study in the United States. Results of the most recent clinical trials of the adjuvanted vaccine suggest it can induce protective antibody levels against A(H1N1) infection within two weeks of administration of a single low-dose. If licensed by the U.S. Food and Drug Administration, the new cell-based vaccine could be purchased for U.S. vaccine stockpiles.
Unlike typical flu vaccines for the U.S. market, which use a 50-year-old egg-based process, cell culture-based production operations are cleaner, can be scaled up more quickly to respond to a pandemic and do not rely on eggs for rapid response to a pandemic, according to Novartis.
“We are proud to be one of the first companies to bring influenza cell culture as well as adjuvant technology to the United States,” says Novartis CEO Daniel Vasella. “We have seen a great need to invest into new technologies for flu vaccines that will allow for quicker and more reliable production capacity.”
The partnership requires Novartis to provide two commercial-scale lots of pre-pandemic vaccine annually for a minimum of three years. In addition, the government has the right to exercise options to purchase additional influenza vaccine over 17 years.
The near-$1 billion investment will support the design, construction, validation and licensing of the manufacturing facility in Holly Springs, North Carolina. The government’s $487 million contribution to the project is “an important step in our ongoing commitment to pandemic preparedness,” says Robin Robinson, director of the HHS Biomedical Advanced Research and Development Authority, which will oversee the government’s contract with Novartis.