Vaccine plant keeps an eye on the future

HOLLY SPRINGS -- For the current pandemic flu, the new vaccine plant in Holly Springs is a $1 billion investment that will open too late to ease current supply problems.

Still, anything concerning the H1N1 virus is today's news.

Novartis pharmaceutical officials said Tuesday they are using the latest technology to attack the outbreaks of tomorrow.

The plant, which had its official opening Tuesday, is months away from churning out the 150 million doses it is designed to produce. Whole sections of key manufacturing areas await drywall, and the lawn out front unfurls in distinct ribbons of sod.

What's more, the flu vaccine the company seeks to produce has yet to be approved by the U.S. Food and Drug Administration - a process the company is working through with late-stage clinical trials.

Not bothered by such details, company officials welcomed dignitaries and the media to a plant that, once production starts in 2011, will likely be off limits to would-be oglers, save for the 350 technicians and managers who will eventually run it.

"We are making a big difference here," said Dr. Andrin Oswald, chief executive officer of Novartis Vaccines and Diagnostics, a division of the Swiss-based pharmaceutical giant. "We are making a promise for the next 20 to 40 years."

Oswald said the plant uses a new technology to cultivate flu virus, cutting production time by weeks, possibly months.

That mission became a top priority for the federal government this decade as avian flu threatened to become a deadly pandemic. The U.S. Department of Health and Human Services invested a reported $2 billion in flu vaccine technologies, including more than $400 million to Novartis for the Holly Springs plant.

Oswald said the new plant eliminates the need for a 50-year-old process of growing large volumes of virus in chicken eggs. It's an antiquated process that's time consuming and clumsy.

At the Novartis plant in Liverpool, England, for example, Novartis runs through 500,000 chicken eggs a day. Each egg is injected with the virus, which replicates to produce enough material that can then be deactivated and processed into vaccine.

That propagation takes time, and when more vaccine is needed in a hurry, egg manufacturers have difficulty ramping up supply - one of the snags in the current pandemic flu vaccine production process.

Also, some flu viruses don't grow well in the egg cultures. The H1N1 strain was slow to replicate in eggs, creating another bottle neck that slowed vaccine deliveries.

A new approach

At the Holly Springs plant, Novartis will instead cultivate the virus in 1,320-gallon vats of a special growth medium that relies on cells isolated from dog kidneys in a biological process not unlike a sourdough bread starter.

That one change speeds a process that takes several weeks in eggs, to just days.

From there, production follows the current process, said Matthew Stober, global head of technical operations for the vaccine division. He said the virus is purified out of its growth medium, and then is fragmented to neuter its ability to cause illness. Single-dose syringes are filled, packed in boxes and shipped.

Novartis officials said an adjuvant is likely to be added in future pandemic vaccines, but probably notin seasonal shots. The adjuvant, an additive that boosts the immune response, has yet to be approved by the FDA and is not included in any current pandemic flu vaccines in the United States.

But Stober said adjuvant is part of H1N1 vaccines in Europe, cutting the dosage people need and stretching supplies. In addition, he said, children and older adults have a much more vigorous immune response with adjuvants.

Novartis' adjuvant, which it calls MF-59, is a form of squalene purified from shark livers.

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