Novartis Vaccine Manufacturing Facility, North Carolina, United States of America

In July 2006 Novartis announced that it would build a new vaccine manufacturing facility in Holly Springs, North Carolina, US. The new 300,000ft² plant was inaugurated on 24 November 2009. The plant is expected to employ approximately 350 personnel from the local area to produce flu vaccines using new technologies.

The facility was constructed on a 167-acre site in Holly Springs Business Park off the NC 55 Bypass. Construction started in the first quarter of 2007 with the first design phase completed in 2008. The plant is expected to be validated by 2011–2012 and operational by 2013.

The initial investment was estimated at $267m but eventually reached $1bn with subsequent phases of expansion. The project remains on track and on schedule.

In January 2009, the US Department of Health and Human Services, Biomedical Advanced Research and Development Authority (HHS BARDA) awarded a contract to Novartis to support the design, construction, validation and licensing of the Holly Springs facility. The eight-year contract is valued at $486m.

Competition and incentives

Several states competed for the manufacturing facility, with its promise of hundreds of jobs and millions in tax revenue. Novartis' selection of the town followed an intensive two-year effort by Holly Springs with assistance from state and county agencies.

Attracting the manufacturing facility required an incentives package that included $8.3m from Holly Springs. The Town Council approved the purchase of the 167-acre site for the facility in the business park for $7.3m from G&G Properties and transferred ownership to Novartis.

The council then approved an additional $1m spending for site clearance. Holly Springs has also received an $800,000 grant from the Golden LEAF Foundation to help fund infrastructure improvements in the business park.

In total, Novartis Vaccines and Diagnostics, a subsidiary of Novartis AG of Basel, Switzerland, received cash grants, land, tax credits and other incentives worth more than $41m from state and local governments. The town property taxes that Novartis paid on the first phase of construction are expected to enable Holly Springs to recoup its investment within ten years.

Holly Springs site evaluation

Securing the project has been the culmination of five years of economic development groundwork by the town council to make Holly Springs attractive to the growing biotech industry. Dr Joerg Reinhardt, CEO of Novartis Vaccines & Diagnostics division, said: "The company evaluated more than 15 sites across the US before choosing Holly Springs."

He cited factors including availability of infrastructure, a well-trained and educated workforce, and quality of life. He concluded: "All of these aspects, at the end of the day, gave the highest scores to North Carolina and Holly Springs." The town hired Jennings Consulting to help market the 400-acre business park for technology manufacturing companies and this helped in the attraction of Novartis.

Infrastructure improvement

Extension of infrastructure was a key part of the process. In 1996 Holly Springs began studying how best to pipe water from Harnett County to supplement the flow from Raleigh.

Construction began in 2000 on a pipeline capable of carrying 10 million gallons a day.

The line was increased to serve large-scale manufacturing operations such as Novartis while accommodating residential growth. With improved capacity, the town is arranging to pipe more water through the line.

Novartis flu vaccine production

The Novartis facility in Holly Springs will be the first manufacturing plant in the US to produce cell culture-derived flu vaccines. The plant will develop vaccines using cell-culture based manufacturing technology.

New flu cell culture vaccine manufacturing technology promises many advantages over traditional egg-based production, including greater reliability and a reduction in production time. Expected to be more clean, the technology can be scaled up at a faster rate than egg-based manufacturing technology.

As of 2009, the cell culture technology for influenza vaccines had not been approved in the US. For developing the flu cell culture vaccine, however, the facility will receive funds from the HHS as part of the contract between the two.

If the vaccine is approved, the facility will be equipped to respond to a pandemic by 2011. Once completed and approved for commercial production the facility is expected to annually produce up to 50 million doses of seasonal trivalent flu vaccines, which will be for use in the US.

In the event of an influenza pandemic, the facility has planned to have a capacity of up to 150 million monovalent doses annually within six months of a pandemic declaration. Novartis is also making investments in its site in Marburg, Germany, to expand capacity for flu cell culture vaccines production in Europe.

The facility will also develop MF59, the Novartis proprietary adjuvant. Adjuvant-based studies are underway in the US and are yet to be approved.

The clinical trials conducted on the MF59 adjuvanted cell culture-based vaccine demonstrated that the levels of protective antibody can be raised against A(H1N1) infection, two weeks after a single dose of adjuvanted vaccine has been administered. Results have also shown that MF59 offers cross-protection against similar strains of a H5N1 virus.