FDA Licenses First US Facility for Cell-Culture Influenza Vaccines
FDA has licensed the Novartis manufacturing facility in Holly Springs, N.C. for the commercial production of cell-culture influenza vaccines. The site, the first US facility of its kind, will produce seasonal and pre-pandemic influenza vaccines, and has the capacity to significantly ramp up production in the event of a pandemic, the company reports.
Novartis uses cell-culture technology to produce Flucelvax (influenza virus vaccine), the first FDA-approved seasonal influenza vaccine not manufactured with chicken eggs. Cell-culture technology offers several potential benefits over traditional influenza vaccine production in chicken eggs, Novartis reports. The manufacturing process can be controlled more easily and is more flexible, enabling the potential to scale up production quickly to develop large quantities of vaccines in the event of a pandemic.
Using the cell-culture technology, Novartis has developed a vaccine candidate for the H7N9 avian influenza virus, which was first reported in China in March 2013. This facility supplied a stockpile of H7N9 vaccine to the US government prior to the second wave of the outbreak in January 2014.
The Holly Springs facility is a result of a joint partnership between Novartis and the US Department of Health and Human Services, Biomedical Advanced Research and Development Authority (HHS, BARDA). The facility was the overall winner of the ISPE Facility of the Year Award in 2013.