Novartis facility grabs FDA license to produce cell-culture vaccines

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After getting the FDA's OK for cell-culture vaccine Flucelvax back in November 2012, Novartis ($NVS) now has a U.S. facility licensed by the agency to produce it. The drugmaker's Holly Springs, NC, plant is now the country's first pandemic-ready site with the regulator's green light to make cell-culture flu vaccines, it said Monday.

The new technology shaves time off the traditional manufacturing process, which uses chicken eggs--a factor especially important when ramping up production in the event of a pandemic, according to Novartis. The site will also be home to the production of pre-pandemic and seasonal flu vaccines, it said.

"With this award-winning, state-of-the-art facility, we will be able to not only offer U.S. consumers an antibiotic- and preservative-free alternative for the yearly seasonal flu vaccination, but also be better prepared for future pandemic threats," Andrin Oswald, head of Novartis Vaccines, said in a statement.

Novartis Vaccines head Andrin Oswald

As far as cell-culture vaccines go, Novartis isn't stopping with Flucelvax. It also has an H5N1 pandemic vaccine in Phase II, and last month its adjuvanted cell culture avian flu vaccine produced positive results. It currently markets flu vax Optaflu in the EU, as well.

"Cell-culture technology is the first major advancement in influenza vaccine production in the U.S. in more than 40 years," Oswald said. "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."

But all of those vaccines may soon be out of the Swiss pharma's hands. After inking a $7.1 billion sale of most of its vax unit to industry giant GlaxoSmithKline ($GSK), Novartis said it planned to sell its flu shot business in a separate deal.

- read the release

Special Reports: Top 5 Vaccine Companies by Revenue - 2012 - Novartis | Major FDA vaccine approvals of 2012 - Flucelvax

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