Twenty miles east of Raleigh, GlaxoSmithKline is writing the latest chapter in its 31-year manufacturing history in eastern Wake County.
Instead of moving operations to Eastern Europe or Mexico, GSK’s Zebulon plant is once again expanding, preparing to add dozens of employees as it ramps up production of several newly approved drugs.
Last week, the plant started manufacturing the Ellipta discus, the next generation of inhaler medical devices. The Food and Drug Administration approved two new drugs, Breo and Anoro, late last year to provide a once daily treatment for chronic obstructive pulmonary disease. The Ellipta device is similar to Advair, GSK’s blockbuster asthma inhaler (packaged in a purple disk), which combines two inhaled drugs and is also made in Zebulon.
Though the Zebulon plant is the epicenter of GSK’s respiratory work, it also packages and produces 20 different brands and products, including drugs such as Potiga, Valtrex and Lamictal.
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“This site has been a pillar for GSK,” said John Bolla, the site director at the Zebulon facility. Besides manufacturing, Zebulon also packages solid dose products that are manufactured at sister sites.
Since moving to the Research Triangle Park in 1971 (as Burroughs Wellcome Co.), GSK has undergone mergers, name changes and corporate streamlining. But since 1983, the 223-acre plant at Zebulon has remained at the heart of GSK’s global operations. The Zebulon plant is one of two manufacturing sites for GSK in North America. The other is in Canada.
In addition to the Ellipta discus, the Zebulon plant is ramping up efforts to start producing Panadol this summer. Panadol is one of the best-selling pain relievers in the world, an acetaminophen tablet sold mostly in Europe.
“This is a significant over-the-counter product for GSK’s global market,” said Bolla. And its production at the Zebulon site, in addition to Ellipta production, means the pharmaceutical giant is hiring: Bolla estimated 60 to 75 people will be hired in the coming month to meet production needs. The plant runs around the clock five days per week.
“GSK wants to have a foothold in the continental United States,” said Bolla. “And it’s Zebulon.”
The expansion of the Zebulon plant comes at a critical time for pharmaceutical manufacturing. Experts who study the business note that big pharma companies face several major hurdles.
“The biggest problem is generics,” said Richard Kouri, the director of the BioSciences Management Initiative at N.C. State University. Kouri said that because drug patents only last for eight to 10 years, drug manufacturers are always trying to add innovative formulations or drug-delivery systems (such as the discus in Advair) to their portfolios.
“Last year was the first year where 50 percent or more of the drugs sold in the United States were generics,” said Kouri. “The trend now is to compete not on outcomes of the drugs but the costs of creating it and manufacturing it. You have to compete based on price, not on patented scripts.”
New changes in health insurance and prescription drug coverage also mean cost needs to be at the forefront of manufacturing decisions. Bernard Munos, a consultant at InnoThink Center for Research in Biomedical Innovation, said the escalating costs of prescription drugs is unsustainable.
In order to overcome these challenges, Munos said, Big pharma is going to have to rethink its business and research model.
“No amount of optimization is going to overcome those challenges,” said Munos. “But it’s an extremely conservative industry that doesn’t like change, even though the traditional model no longer works.”
GSK employs about 4,500 people at its North American headquarters in RTP. The Zebulon site employs 450 people to support the manufacturing plus 150 contractors. At one time, the Zebulon site had double that number of employees before several rounds of layoffs last decade.
GSK says improved manufacturing techniques mean fewer workers are needed for the assembly lines at the plant. Bolla said about 50 percent of the employees are from Zebulon, where GSK is the largest employer, or the surrounding area.
The plant is also one of the few places in Zebulon where someone with a high school degree can get an entry-level job and over the course of a decade rise in rank and degree.
Shaun Venable started working base operator jobs, working the assembly lines during night shifts, when she was 18.
“I was on the assembly line three days a week,” said Venable, who lives with her husband and children in Zebulon.
Venable decided to take advantage of GSK’s continuing education programs, taking various courses at Wake Technical Community College and N.C. State; she plans to enroll in a four-year program at N.C. State next spring. She has moved off the assembly line and up the ranks at the Zebulon plant over the last 15 years. She’s now a regulatory compliance specialist.
Bolla works with the state’s chamber of commerce on initiatives to train experienced employees in new technologies, and is reinstituting apprentice and study programs at Wake Tech and other area schools to bring local workers to Zebulon. He said GSK is also committed to using local materials, getting the plastic for its Advair discs from a supplier in Asheville.
“We try to keep products local in the U.S.,” said Bolla.
Kouri said keeping it local is a smart business move for pharmaceutical companies.
“Cost of manufacturing isn’t that much cheaper in emerging economies,” Kouri said. “The idea of counterfeit drugs is one of the reasons” there are fewer and fewer advantages of doing manufacturing outside of the U.S.
GSK’s expansion in Zebulon is welcome news for economic boosters in the state who are eager to rebuild North Carolina’s manufacturing base.
The N.C. Biotechonology Center estimates that there are 22,578 North Carolinians working in pharmaceutical manufacturing, a 7.8 percent increase since 2006. Jim Shamp, the center’s spokesman, said there are 41 bio and pharmaceutical manufacturing sites in the state operated by 33 companies.
For the last half century, North Carolina has actively courted biotech and pharmaceutical companies to do business here, not least by allocating state funds for training programs such as BTEC. The biomanufacturing training and educational center at N.C. State helps undergraduates and graduate students simulate working in pharmaceutical manufacturing.
Ruben Carbonell, the director of BTEC, said North Carolina is ranked third behind Massachusetts and California in terms of having the most biotech companies active in the state. But Carbonell said those states are focused on drug discovery; North Carolina’s strength is bio and pharmaceutical manufacturing.
“Sixty-four percent of our graduates end up inside the state,” said Carbonell, who added that 98 percent of BTEC students are employed within six months of graduation.
“It’s a great investment in the state (that) needs the manpower,” said Carbonell. “The fact that we’re here helps companies to decide to come here.”