FDA approves Novartis U.S. vaccine plant it is trying to sell

Flu cell fementer at a Novartis plant--Courtesy of Novartis

Novartis' ($NVS) $1 billion influenza vaccine manufacturing plant in Holly Springs, NC, has just become the first pandemic-ready site FDA-approved to make cell-culture influenza vaccines. Now it needs to find a buyer for the facility.

The company said Monday that the plant, which will make seasonal and prepandemic influenza vaccines, is now ready for commercial production. In November 2012, the company received FDA approval for Flucelvax, which will be manufactured using a mammalian cell-culture system that will shave about four weeks off the process compared with using eggs and eliminates the need to keep a stock of eggs. It uses the same system at a plant in Marburg, Germany.

The Holly Springs plant, which has been under construction since 2008, is among several in the U.S. being built with the assistance of federal funds. The U.S. can then rely on these plants for vaccine supply in the case of a pandemic. Novartis has said the joint investment in the technology and plant has been about $1 billion, of which the U.S. has chipped in about half.

"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, who heads Novartis' vaccine division, said in a statement.

After agreeing in April to sell the rest of its vaccine business to GlaxoSmithKline ($GSK) in a complex deal, the Swiss drugmaker said it would look for a separate buyer for its influenza vaccines business. The flu vaccine operations include a manufacturing site at Speke in the U.K.

The Holly Springs site has 800 employees, including 250 contractors, Novartis spokeswoman Elizabeth Power said in an email. The site is comprised of half a dozen buildings that include 475,000 gross square feet (44,130 square meters) of space dedicated to manufacturing. It has facilities for bulk production, secondary production and a viral pilot plant. It also has warehouse facilities, maintenance, quality-control testing and office buildings. The facility has so far been used to produce the Novartis MF-59 adjuvant and has also produced clinical supply material.

GlaxoSmithKline is another of the companies participating in the federal pandemic readiness program. GSK and Texas A&M have the go-ahead to build a $91 million influenza vaccine plant northwest of Houston at the Texas A&M Center for Innovation in Advanced Development and Manufacturing. GSK will use the facility to manufacture vaccines using the EB66 cell culture line it licensed from Vivalis ($VLS).

- here's the announcement