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N.C. Novartis Site Is First Cell-Based Flu Vaccine Facility in the Country

By MedCity News – Updated Apr 6, 2017 at 5:03PM

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A Novartis' vaccine facility in North Carolina today became the first facility authorized by the FDA for emergency use during a pandemic.

If a flu pandemic strikes the United States, a Novartis (NYSE: NVS) plant in North Carolina now stands ready to respond with vaccine techniques that offer speed and scalability advantages over traditional vaccine-making methods.

Novartis' vaccine facility in Holly Springs, North Carolina today became the first cell culture vaccine facility authorized by the U.S. Food and Drug Administration for emergency use during a pandemic. The plant will develop vaccines from cultured animal cells, in contrast to the traditional method of making flu vaccines from chicken eggs.

"Today we're marking the first change in influenza vaccine manufacturing in the United States in 50 years," Robin Robinson, director of the Biomedical Advanced Research and Development Authority, or BARDA, said in a statement. "The pandemic readiness of this facility is a major milestone in national preparedness for pandemic influenza and other diseases."

Egg-based vaccine production comes with problems including possible impurities in the eggs. The egg-based method also takes longer because it can be hard to procure the number of eggs needed for vaccine production. That makes egg-based vaccine production ill-suited to responding quickly to a pandemic. But vaccines cultured in animal cells can be scaled up quickly, which means a faster pandemic response.

The Novartis site is designed to provide 150 million adjuvanted doses of pandemic influenza vaccine within six months of declaration of an influenza pandemic. In the event of an influenza pandemic, the new Novartis facility could produce up to 25 percent of the vaccine needed in the United States. The cell-based technology employed by the plant could also be adapted to produce vaccines for other infectious diseases in an emergency. The new Holly Springs plant came about in partnership with the federal government. Novartis and HHS collaboration committed $1 billion to the facility, with federal funds coming from BARDA.

Novartis was awarded a Department of Health and Human Services contract in 2006 that called for the pharmaceutical company to develop an influenza cell culture vaccine and also to develop and design a U.S. manufacturing facility for that vaccine. Novartis broke ground for the facility in Holly Springs in 2007.

Novartis executive Russell Thirsk spoke with MedCity News in September regarding the company's Holly Springs vaccine facility. Click here to see him explain how cell culture vaccine production differs from making vaccine from fertilized eggs.

Novartis' Holly Springs site is not the only facility that has received federal support to develop new vaccine response capabilities. Biotechnology company Medicago last year received a $21 million contract from the U.S. Defense Advanced Research Projects Agency, or DARPA, which was seeking scalable vaccine manufacturing facilities that can respond to natural and bioterrorism virus outbreaks. Medicago in November opened its new vaccine facility in Research Triangle Park, North Carolina. The facility, which makes virus-like particles from tobacco leaves, is designed to make up to 120 million doses of pandemic flu vaccine and 40 million doses of seasonal influenza vaccine.

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