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Novartis Teams Up With the US for Vaccines


Reducing our reliance on chickens for flu technology.

The latest technology in vaccine production just got a little closer to home.

On Tuesday, Novartis (NVS), the third-largest pharmaceutical company in the world by market cap, announced the inauguration of the first US-based large-scale flu cell culture vaccine and adjuvant manufacturing facility in Holly Springs, North Carolina.

The plant, located southwest of Raleigh, was a $1 billion investment for Switzerland's Novartis and the US Department of Health and Human Services. It will be used to make cell culture-based vaccines and adjuvants, the add-ons often included in vaccines that help boost effectiveness. None of the current US flu vaccines allow adjuvants. See also Big Pharma Scrambles for a Piece of the Vaccine Pie.

Cell culture-based vaccines are the latest technology that may someday replace egg-based vaccines. The traditional process uses fertilized chicken eggs to harvest the vaccine. The slow process that has been used for more than a century requires multiple eggs for a single dose and up to six months for production.

This has become a major issue of late as the US and other countries try to make enough doses of the H1N1 swine flu vaccine to reach everyone who would like to be inoculated.

Meanwhile, the cell culture-based method allows for large batches of vaccine to be produced at one time in huge fermenting vats. The cultures could be grown as demand requires, unlike eggs which can't be supplied as needed.

The cell cultures are also advantageous because they don't carry the risk of impurities that eggs can have and they have less potential for allergic reactions.

"We are proud to be one of the first companies to bring influenza cell culture as well as adjuvant technology to the United States," said Novartis Chairman Daniel Vasella. "We have seen a great need to invest into new technologies for flu vaccines that will allow for quicker and more reliable production capacity."

Cellular-based vaccine technology hasn't yet been approved in the US by the Food and Drug Administration, but would be likely utilized in the event of another pandemic threat.

The government's Public Readiness and Emergency Preparedness Act provides for unapproved vaccines to undergo a series of trials that would allow the drugs to reach the approvable phase of the regulatory process in a shorter amount of time. The drugs in this program can only be sold to the US government. The PREP Act gives immunity to manufacturers against liability for the drugs.

Virtually all the major vaccine manufacturers are working on some sort of cell-based production method, including Sanofi-Aventis (SNY) and Inovio Biomedical (INO).

Novartis says the new facility could be ready to respond to a pandemic as early as 2011 if licensed in an emergency, and that the plant will be running at full-scale commercial production by 2013. The Swiss company already operates a similar plant in Marburg, Germany, where it produces the seasonal cell culture-based influenza vaccine Optaflu.

There are currently two strains of the flu circulating around the US, the seasonal flu and the H1N1 virus. The World Health Organization is also monitoring the deadly H5N1 Avian flu. In a typical year, about 5% to 20% of the population gets the seasonal flu and approximately 36,000 Americans die from flu-related deaths.
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