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U.S. Department of Health and Human Services


Award Winning Pandemic Influenza Preparedness

Author: Robin Robinson, Ph.D., Director, Biomedical Advanced Research and Development Authority
Published Date: 11/13/2013 3:35:00 PM
Category: Medical Countermeasures; Public Health Preparedness;

Novartis Team at Holly Springs recognized for innovation and advancements in pharmaceutical manufacturing technology

Author: Robin Robinson, Ph.D., Director, Biomedical Advanced Research and Development Authority

Congratulations to the Novartis team in Holly Springs, N.C. Last week the vaccine manufacturing facility there earned the 2013 Facility of the Year recognition from the International Society for Pharmaceutical Engineering. I’m proud that BARDA has been an integral part of the public-private partnership that established the facility.

In 2006 as part of our overall pandemic preparedness strategy we began investing in Novartis and other major vaccine companies to drive influenza vaccine manufacturing from traditional egg-based technology toward modern technologies like cell-based vaccines. This investment led, in 2012, to FDA licensure of the first cell-based seasonal influenza vaccine – Novartis’ Flucelvax. This approval marked the first change in influenza vaccine manufacturing in the United States in 50 years.

As part of this investment, we partnered with Novartis to build the vaccine manufacturing facility in Holly Springs, which was completed in 2011, became capable of producing pandemic influenza vaccines in 2012, and is making H7N9 vaccine currently. The facility also manufactures adjuvants that may be used with vaccines. Additionally the facility serves as a national pre-pandemic influenza vaccine stockpile manufacturer and storage site.

In a pandemic, the facility may be able to produce 25 percent of the vaccine needed in the United States. In addition, cell-based technology used in this facility for manufacturing seasonal and pandemic influenza vaccines may be adapted in an emergency to produce vaccines and biological products for other emerging infectious diseases or man-made threats.

In 2012, we designated Novartis and this flexible manufacturing facility as one of the three domestic Centers for Innovation in Advanced Development and Manufacturing. The centers will provide core service assistance in product development and manufacturing to CBRN medical countermeasure developers on a routine basis.

In an influenza pandemic, the centers will provide at least 50 million doses of pandemic influenza vaccines using cell- or recombinant-based vaccine technologies within four months of pandemic onset. The centers also will manufacture vaccines or biological products to other threats in a public health emergency and will provide workforce training to the next generation of biopharmaceutical and vaccine developers and manufacturers in the United States.

These advancements are part of BARDA’s strategic aims to provide more and better influenza vaccine quicker for the nation in a pandemic. We’re also expanding the manufacturing surge capacity in the United States. We’ve worked with industry to retrofit facilities and to create a new fill finish network, which covers the final steps in the vaccine manufacturing process. We also ensured year-round supplies, such as eggs, used in developing traditional flu vaccine.

The International Society for Pharmaceutical Engineering says their annual award showcases shared commitment and dedication to enhancing patient health and safety through innovation and advancements in pharmaceutical manufacturing technology. To me, the award validates the level of excellence and scientific advances that can be made when government and private industry work together toward a common goal.


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