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Novartis Celebrates Pandemic Readiness

 
Novartis Vaccines President Vas Narasimhan  

Local, state and federal government leaders joined hundreds of employees at the massive Novartis vaccine manufacturing facility in Holly Springs this morning to celebrate the $1 billion factory’s first production of flu vaccine using the highly efficient process of cell culture.

Though the factory won’t be certified by the U.S. Food and Drug Administration to sell seasonal flu vaccine for another year or so, Novartis has begun producing a federally requested stockpile of vaccines that could be disseminated without FDA’s usual approval process in the event of a surprise outbreak of, say, a potentially deadly strain of avian flu.

Last Friday, Dec. 9, some of the 400 workers at the Novartis plant reached a milestone when they released their first three batches of an H5N1 bird flu vaccine into the factory’s storage facility.

   
Federal officials Robinson, Lurie present pandemic readiness recognition plaque to Novartis' Narasimhan, McDonald    

It’s an important milestone, said one of the day’s speakers, Nicole Lurie, Ph.D., assistant secretary for Preparedness and Response with the U.S. Department of Health and Human Services.  In the event of a flu pandemic, she said, at least 25 percent of the nation’s vaccine protection will come from this factory.

“Novartis is proud that our Holly Springs facility is the first of its kind in the United States, a testament to our commitment to help protect public health by providing innovative vaccines,” said Vas Narasimhan, M.D., president of US Vaccines and head of North America Vaccines for Novartis.

Governor Bev Perdue, Senator Richard Burr and Congressman David Price also spoke at the event, and Senator Kay Hagan sent a pre-recorded video speech.

After the program, the guests were treated to a luncheon in a tent reminiscent of the one used for the campus groundbreaking ceremony. Novartis, after absorbing California-based Chiron, decided in 2006 to build the plant in North Carolina. Employees started work there in 2009.

The 167-acre Novartis Holly Springs site now holds six connected buildings comprising 430,000 square feet of manufacturing, laboratory and office space.

The company plans to employ 500 at the campus by the end of 2012, when it completes construction of an additional $36 million development laboratory and pilot plant facility adjacent to the current building.

The Novartis facility also produces a vaccine “booster” ingredient, called an adjuvant, that helps excite the body’s immune system to provide more protection from invading pathogens with less vaccine. Novartis uses an adjuvant derived from shark’s livers, though company officials are quick to note that sharks are not killed for that purpose.

   
This tent, sitting here in an open field for groundbreaking three years ago, now houses luncheon guests for pandemic readiness celebration at new $1 billion Novartis vaccine factory    

This is the first U.S. facility to use the faster and more flexible cell-culture technology to make influenza vaccine. It creates vaccine using cultured animal cells instead of the conventional process of using fertilized chicken eggs. The facility is a public-private partnership of HHS and Novartis Vaccines and Diagnostics, headquartered in Cambridge, Mass. The partnership will be maintained under contract for at least 25 years.

Robin Robinson, Ph.D., director of the Biomedical Advanced Research and Development Authority in HHS's Office of the Assistant Secretary for Preparedness and Response (ASPR), led the effort for HHS. He said the plant represents the first change in influenza vaccine manufacturing in the United States in 50 years.

HHS and Novartis are partnering with Synthetic Genomics Vaccines of Rockville, Maryland on new technologies to shorten the vaccine manufacturing timeline by optimizing vaccine virus seed strains used for flu vaccine production. Synthetic Genomics is a privately held company that was formed in October 2010 by merging the non-profit J. Craig Venter Institute and a California company, Synthetic Genomics.

BARDA and Novartis also are working with North Carolina State University’s Biomanufacturing Training and Education Center (BTEC), the BioNetwork community college program and other specialty training programs in North Carolina to deliver the company’s highly skilled workforce.

BTEC is training scientists from other countries to use cell culture-based manufacturing techniques similar to that used in the Holly Springs facility. The training program is part of a World Health Organization initiative to strengthen the ability of developing countries to produce flu vaccine, potentially reducing the global threat from influenza.

Robinson and Lurie presented Novartis with a plaque commemorating the public-private partnership between the United States government and the company to build the facility.