that the centers be able to deliver the first doses for distribution within 12 weeks. The reason for three centers is not for geographic diversity. While there is some overlap among the centers, each center has capabilities that set it apart from the others, Robinson explains.
The Novartis Holly Springs site stands apart because of new technology that can produce vaccines in animal cells through a process called cell culture. Flu vaccines have traditionally been produced by growing the virus in chicken eggs, which can take up to six months. Instead, Novartis’s Holly Springs plant makes flu vaccine from animal cells, specifically, a cell line from a dog’s kidney. This cell culture process takes about 30 days.
Novartis broke ground in Holly Springs in 2009. Two years later, the plant was ready for production. In June, the Food and Drug Administration licensed the Novartis facility to produce seasonal flu vaccine made from cell culture. This facility is the first, and so far only, plant in the United States approved by the FDA to manufacture influenza vaccine cultured in animal cells. It will produce about 50 million doses of seasonal flu vaccine annually, but it has the capacity to expand in emergencies. The Novartis site was designed to have the capacity to produce 200 million doses of flu vaccine within six months of the declaration of a flu pandemic.
The ability to quickly manufacture large quantities of medicine would allow the response center to meet government orders for vaccines or drugs during an outbreak of infectious disease, such as flu, or even Ebola.
“That’s what the cell culture [technology] is predominantly about,” says Brent MacGregor, Novartis’s president of U.S. vaccines. “We’re able to scale up more quickly in the event of a pandemic than would otherwise be the case with egg production.”
The Holly Springs plant already has experience responding to a global pandemic threat. When H7N9 influenza emerged in China last year, Novartis scientists in North Carolina received information about the flu strain from health officials in China. Novartis then used its cell culture technology to develop a vaccine. That H7N9 work emerged from research funded by a separate federal grant awarded to Novartis, which supported a collaboration with the J. Craig Venter Institute in San Diego to use synthetic biology to make new influenza vaccines. The H7N9 vaccine produced by Novartis remains stockpiled, for use if needed, in Holly Springs.
In the event of an emerging infectious disease within the United States, the government would take similar steps to respond to the threat. One or more of the response centers could be tasked with making a drug or vaccine for the disease, Robinson says. Those drugs can come from any number of drug companies, including small biotechs such as Mapp Bio. While the Novartis plant in Holly Springs was built for vaccine production, Robinson says its cell culture manufacturing technology makes it capable of manufacturing biological drugs, like ZMapp.
“It’s a biological, a monoclonal antibody,” Robinson says. “So they could make it here.”
