FDA chief visits Triangle

Novartis gears up for flu shots

dranii@newsobserver.comSeptember 30, 2011 

  • 430,000

    Square footage of Novartis' five inter-connected buildings in Holly Springs


    Tons of steel used in construction


    Tons of ductwork at the plant


    Total length, in miles, of pipes at the plant

    150 million

    Doses of influenza vaccine the plant is designed to produce within six months of a pandemic declaration


    Current workforce


    Projected workforce

    $1 billion

    Total investment, including more than $400 million in federal funding

    $36 million

    Cost of a new research lab and pilot plant being built at the site for developing new vaccines. Construction began in March. Operation is expected to begin in April


    Total Novartis employment in North Carolina at facilities in Greensboro, Wilson and Holly Springs

    Source: Novartis

Novartis' innovative $1 billion flu vaccine facility in Holly Springs was the logical centerpiece for FDA Commissioner Margaret Hamburg's visit Thursday to the Triangle.

"They are using new science to make better vaccines quicker," said Sam Taylor, president of the N.C. Biosciences Organization, the industry trade group that invited Hamburg to visit the area. "That is a huge, huge achievement."

The 430,000-square-foot plant, which opened in November 2009 and currently employs 400 workers, is expected to be engaged in full-scale commercial production of seasonal flu vaccine in 2013. It's the first U.S. vaccine plant to propagate the virus used to make the vaccine in a special growth medium called a cell culture, rather than the traditional poultry eggs. That virus is then disabled, so to speak, so that it can't cause illness and is vaccine-ready.

Although the plant isn't yet licensed by the Food and Drug Administration, Novartis expects by the end of this year to be ready to swing into action if an influenza pandemic strikes.

With "emergency use authorization" from the FDA, it could churn out 150 million doses of vaccine within six months.

That's a significantly faster turnaround than is possible with traditional vaccine plants, which was a key to winning federal funding for the plant. The approximately $1 billion investment includes more than $400 million from the U.S. Department of Health and Human Services.

"If we get a strange flu strain that we haven't seen before and it is threatening a pandemic, you want a lot of doses in a hurry," said Jim Shamp, spokesman for the N.C. Biotechnology Center.

Hamburg, who toured the plant Thursday afternoon with about a half-dozen other senior FDA officials, called the facility "very impressive."

"It is really an excellent demonstration of the importance of innovation and collaboration, the coming together of government and industry to advance public health preparedness," she said.

Hamburg said she makes a point of going to industry hubs such as the Triangle for an "on-the-ground perspective" of what's happening and to "hear first-hand people's issues and concerns, what's working and what isn't."

Toward the end of the vaccine plant tour, she joked to Novartis officials, "When I visited a food plant last week, they gave us all samples, but I guess you can't do that."

Novartis recently bought a 14.5-acre plot adjacent to the plant's 161-acre site with an eye toward long-term expansion.

"We have no immediate plans for it," said Russell Thirsk, who's in charge of technical operations. "But clearly, we have high hopes to develop our operations here in North Carolina."

Thirsk added that Novartis also has options to buy additional parcels of land.

"We have found it a good place to do business," he said. "We have been pleasantly pleased with the talent we've been able to attract."

Ranii: 919-829-4877

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