FDA approves Novartis vaccine plant in Holly Springs

Posted by John Murawski on June 17, 2014 

Federal regulators have issued approval for a five-year-old vaccine plant in Holly Springs that Swiss drugmaker Novartis said will be the first U.S. facility to make commercial supplies of flu vaccine from cell cultures instead of chicken eggs.

The U.S. Food and Drug Administration approved the $1 billion facility this week, a year later than originally expected, clearing the plant to make commercial vaccine for seasonal influenza. Previously the Novartis facility was authorized only to make emergency vaccine for flu pandemics, events so unusual that only four have been documented in the past century.

The FDA approval comes at a time that Novartis, which employs 135,000 people worldwide, is exiting its vaccines business, and is expanding its oncology treatment portfolio. The company is soliciting bids for its flu vaccines and products, which includes the Holly Springs vaccine plant, as it sheds money-losing investments and focuses on new growth areas.

Using cell cultures to make flu vaccine is considered advantageous because production time is reduced from several months to several weeks, the company said, and it is not dependent on eggs from chickens that could be wiped out by avian flu.

About half the funding for the 430,000-square foot facility came from the U.S. Department of Health and Human Services and the Biomedical Advanced Research and Development Authority, or BARDA. The federal government has backed the project as part of the nation’s public safety program against potentially fatal flu outbreaks.

The facility employs about 800 scientists and others and was built with more than $40 million in state and local incentives, including land, roads and other infrastructure provided by the town of Holly Springs.

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