An American revolution entered the healthcare history books on Monday.

Seven years after construction began on the $1 billion Novartis Holly Springs cell culture vaccine manufacturing facility, federal regulators have approved the factory’s output of Flucelvax flu vaccine for sale in the United States.

The revolution has nothing to do with its proximity to the July 4 Independence Day holiday. Rather, it’s in the way Flucelvax is made. It’s the first flu vaccine produced without antibiotics and preservatives, using a unique biological “soup” called cell culture.

It’s an alternative to traditional flu vaccine manufacturing, which occurs in eggs. The process is one of the most significant advancements in flu vaccine manufacturing in more than 40 years.

It’s also one of the reasons North Carolina leads the world in vaccine development and manufacture, with new technologies capable of producing tens of millions of doses a month when the next pandemic hits.

There are nearly 800 people working at the Novartis campuses in North Carolina: 540 full-time employees and 250 contractors. Of those, 60 are working at a newly leased R&D facility in Research Triangle Park.

The state boasts 28 vaccine companies employing 13,000 people. That includes Medicago’s $42 million factory in Research Triangle Park, which is also awaiting FDA approval for its vaccines derived from viral-like particles “grown” in tobacco leaves. Medicago already passed one government test for high-speed output, producing 10 million doses of flu vaccine in a month.

Though Flucelvax was approved by the U.S. Food and Drug Administration in November 2012 for sale in the U.S., the Basel, Switzerland-based medical giant had to ship the product from a sister factory in Marburg, Germany. Now, all the company’s North American Flucelvax sales will come from Holly Springs.

The approval makes the Novartis biomanufacturing facility the first pandemic-ready site to be licensed by the FDA for making cell-culture flu vaccines.

The Novartis and Medicago facilities were built in partnerships with the U.S. Department of Health and Human Services, Biomedical Advanced Research and Development Authority to better protect the public in the event of a pandemic or other health security threats.

The Novartis facility won the International Society for Pharmaceutical Engineering’s Facility of the Year Award in 2013.

Editor’s note: Jim Shamp is director of public relations for the N.C. Biotechnology Center.

(C) N.C. Biotechnology Center