FDA Licenses Novartis’ N.C. Flu Vaccine Facility

The FDA has licensed Novartis’ manufacturing facility in Holly Springs, N.C., for the production of cell-culture influenza vaccines, making it the first such facility of its kind, the company announced.

The facility is a result of a joint partnership between Novartis and the HHS Human Services, Biomedical Advanced Research and Development Authority, part of an investment to better protect the public in the event of a pandemic or other health threats.

The site will produce seasonal and prepandemic flu vaccines, and has the capability to significantly ramp up production in the event of a pandemic, the Basel, Switzerland-based company said. With the licensure of the Holly Springs facility, Novartis’ influenza virus vaccine will be produced in the U.S. for the first time, it added.

Novartis produces Flucelvax using cell culture technology. It is the first FDA-approved seasonal flu vaccine not manufactured with chicken eggs, and does not contain any antibiotics or preservatives, the company said.

Cell-culture technology offers benefits over traditional influenza vaccine production, which occurs in chicken eggs. Manufacturing can be more easily controlled and is more flexible, enabling the potential to scale up production quickly to develop large quantities of vaccines in the event of a pandemic, the company said. — Kellen Owings

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