Employees rolled up their sleeves at the $1 billion Novartis (NYSE: NVS) Holly Springs vaccine manufacturing facility this week and joined the global throngs marking a revolution in the fight against flu.
The revolution is in the creation of Flucelvax, a flu vaccine produced without antibiotics and preservatives using a unique biological “soup” called cell culture. When Flucelvax was approved by the U.S. Food and Drug Administration last November, it became the first cell-culture derived flu vaccine allowed in the U.S.
It’s an alternative to traditional flu vaccine manufacturing, which occurs in eggs. The process is one of the most significant advancements in flu vaccine manufacturing in more than 40 years.
Brent MacGregor, who joined the company a year ago to become president of its U.S. vaccines operations and head of the North American region, said that because Flucelvax isn’t in commercial production yet at the Holly Springs site, some 600,000 doses have been shipped to U.S. consumers from the company’s Marburg, Germany plant. More are on the way, he said, noting that the company plans to sell 2.2 million doses this first year and six million in 2014.
Chris McDonald, head of Novartis’ Holly Springs site, said he expects to get the okay from FDA inspectors soon to begin commercial manufacturing of the vaccine, which will result in all the company’s North American Flucelvax sales coming from Holly Springs in 2014.
The site is already bustling with some 530 full-time employees, called “associates,” and about 230 contract workers. About 30 of the employees will soon be moving to newly rented R&D facilities in Research Triangle Park (See accompanying story).
McDonald said one of his first stops after Novartis chose North Carolina for its new flu plant was a Valentine’s Day 2007 recruiting visit to a North Carolina State University career fair.
NCSU Chemical Engineers ‘My Best Hires Ever’
“I hired 15 chemical engineers that day, and they were my best hires ever,” he recalled. McDonald said North Carolina’s skilled workforce and supportive environment, including the North Carolina Biotechnology Center, have always been and continue to be a major draw for Novartis and other biomanufacturers.
He noted, however, that businesses still face a shortage of entry-level technicians. He said there are excellent career opportunities for two-year community college graduates trained to work in such highly skilled jobs as instrumentation technicians and process mechanics who can perform the specialized motor repairs and other jobs that keep the extremely sterile and closely regulated biomanufacturing sites humming.
“Thank You, Novartis”
Holly Springs Mayor Dick Sears showed up at the vaccination celebration with a shiny gold-colored shovel, accompanied by several other members of the town government. Sears said it’s the shovel he wielded at Novartis’ 2007 groundbreaking ceremony, and he’s anxious to use it again in three weeks when Novartis breaks ground on a previously announced $47 million expansion of the biomanufacturing campus that has transformed the community.
Sears said land acquisition, site clearing, infrastructure installations and other incentives provided by the town to help lure Novartis were recouped by the town six months ago, and other investments by the community such as the construction of Green Oaks Parkway through the surrounding industrial park will be paid off in six more months.
That’s opening the door to decades of growth for the town and its tax base, said Sears. He said the community’s tax base was about $1 billion in 2007, and it now stands at some $3.5 billion, making Holly Springs one of the nation’s fastest-growing communities.
“Thank you, Novartis, for being who and what you are,” said Sears.
(C) NC Biotechnology Center