Novartis Receives FDA OK for US Cell-Culture Flu Vaccine-Manufacturing Facility
Novartis reports that the US Food and Drug Administration (FDA) licensed its manufacturing facility in Holly Springs, North Carolina for the production of cell-culture influenza vaccines, making the facility approved for commercial production. The site will produce seasonal and pre-pandemic influenza vaccines and has the capacity to ramp up production in the event of a pandemic.
Novartis uses cell-culture technology to produce Flucelvax (influenza virus vaccine), which was the first FDA-approved seasonal influenza vaccine not manufactured with chicken eggs, the traditional manufacturing method for producing influenza vaccine, according to Novartis. With the licensure of the Holly Springs facility, Flucelvax will be produced in the US for the first time. Cell-culture technology offers several potential benefits over traditional influenza vaccine production, which occurs in chicken eggs. 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. Novartis recently used the technology to develop 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.