Pharmaceutical Business review

FDA licenses Novartis’ Holly Springs facility for cell-culture influenza vaccines production

Novartis’ facility in Holly Springs is the first US facility of its kind and is now approved for commercial production.

The facility will produce seasonal and pre-pandemic influenza vaccines, and has the capacity to significantly 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 company said that Flucelvax, which is approved for individuals 18 years of age and older, does not contain any antibiotics or preservatives.

Novartis Vaccines division head Andrin Oswald said cell-culture technology is the first major advancement in influenza vaccine production in the US 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," Oswald said.

"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 cell-culture technology provides several potential benefits over traditional influenza vaccine production, which occurs in chicken eggs.

According to the company, the manufacturing process can be controlled more easily and is more flexible, allowing the potential to scale up production quickly to develop large quantities of vaccines in the event of a pandemic.

In March 2013, the company used the technology to rapidly develop a vaccine candidate for the H7N9 avian influenza virus, which was first reported in China.