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Novartis Preparing for Pandemic

Novartis preparing for pandemic [The News & Observer, Raleigh, N.C.]

From News & Observer (Raleigh, NC) (December 13, 2011)

Dec. 13--HOLLY SPRINGS -- Pharmaceutical giant Novartis on Monday declared its $1 billion vaccine production plant, the first such facility of its kind, ready to inoculate Americans against the next global pandemic outbreak.

Gleaming in the outskirts of this small community, the sprawling laboratory is more than four years in the making. It is designed to supply emergency vaccine to one in every four U.S. residents during a pandemic, an event so unusual that only four have swept the globe in the past century, most recently in 2009.

The facility produced its first three batches of pandemic flu vaccine Friday, about 6.5 million doses of the watery-looking stuff in pre-dosed glass vials ready for injection, all designated for the U.S. emergency stockpile.

It's the nation's first mass-scale plant that makes vaccines from animal cell culture rather than chicken eggs -- a considerable advantage if an avian flu outbreak were to kill off the chickens that lay the eggs needed to make vaccines, said Vas Narasimhan, president of Novartis Vaccines USA, based in Massachusetts.

About 400 scientists and other specialists work here, a workforce that's expected to grow to more than 500 next year. The U.S. Department of Health and Human Services paid $487 million toward the 430,000-square-foot complex as part of a national public safety program.

"This will be the first time we have the potential in human history to actually avoid a pandemic, or neutralize it," said Rich McKeown, a former executive with the federal agency, as he spoke to a gathering of several hundred guests and employees who had assembled for a dedication in the building's a solarium-like cafeteria.

The Novartis vaccine lab is an ambitious attempt to make the country safer in a post-9/11 world where the government fears both natural and man-made pandemics. It would take about six months to produce the 150 million doses this facility is designed for, which is about 25 percent faster than the current method.

The project has been a windfall for the town of Holly Springs and its 25,000 residents in southwestern Wake County. The Novartis facility will contribute $1.4 million to the community's tax revenues this year, accounting for 11.3 percent of its tax receipts, said Holly Springs finance director Drew Holland.

A tour of the facility revealed a maze of double-doors and hallways lined with windows showing antiseptic rooms filled with stainless steel bioreactors, harvest tanks, centrifuges, valves and dials. The viruses are grown in a cell line harvested in the 1950s from the kidney of a female cocker spaniel, according to the U.S. Food and Drug Administration.

The facility is also equipped to manufacture a conventional vaccine for the seasonal flu, the type for which many people get every year. But it will be at least two years before federal regulatory approval is expected that would allow Novartis to use its new labs to make seasonal vaccines.

During a pandemic, however, the feds would waive the regulatory license and have the lab converted to a round-the-clock mass-production facility for emergency vaccine.

"Our hope, as we improve and scale up this process, is that we'll get even faster over time," Narasimhan said.

Murawski: 919-829-8932


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Posted: December 2011