News Feature | June 16, 2014

Novartis Facility Licensed By FDA For Cell-Culture Flu Vaccines

By Estel Grace Masangkay

Novartis announced that the U.S. Food and Drug Administration (FDA) has granted license to its manufacturing facility in Holly Springs, N.C. for the production of cell-culture influenza vaccine.

Flucelvax is a vaccine indicated for the protection against influenza for people aged 18 and above. The licensure enables the facility to commercially produce the vaccine in the U.S. for the first time, as well as to ramp up production in case of a pandemic.

Cell-culture technology offers better control, flexibility, and a quick scaling up of production of large amounts of vaccine compared to the traditional vaccine production which uses chicken eggs. Novartis reported that it used cell-culture to quickly develop a vaccine for the H7N9 avian flu virus for the U.S. government prior to the second reported wave of the outbreak earlier this year.

Andrin Oswald, Division Head of Novartis Vaccines, said, “Cell-culture technology is the first major advancement in influenza vaccine production in the U.S. in more than 40 years. We are proud to be at the forefront of this innovation, which will allow us to deliver on our public health and health security commitments. With this award-winning, state-of-the-art facility, we will be able to not only offer US consumers an antibiotic- and preservative-free alternative for the yearly seasonal flu vaccination, but also be better prepared for future pandemic threats.”

The Holly Springs facility is the product of a joint public-private collaboration between Novartis and the US Department of Health and Human Services, Biomedical Advanced Research and Development Authority (HHS, BARDA). The project has been funded by the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority.

The facility was also named as the overall winner of the ISPE Facility of the Year Award in 2013 and is intended to promote innovation for the benefit of public health against pandemics and other health security threats.