Novartis Inaugurates New Influenza Vaccine Manufacturing Facility

Published: 24-Nov-2009

To begin full scale commercial production in 2013

Novartis has officially inaugurated the its large-scale flu cell culture vaccine and adjuvant manufacturing facility in Holly Springs, North Carolina. The facility is a result of a partnership between Novartis and the US Department of Health and Human Services (HHS).

The total investment in the facility is nearly $1 billion, through a partnership between Novartis and HHS to support the design, construction, validation and licensing of the manufacturing facility in Holly Springs.

The operations at this facility will use cell culture-based manufacturing technology. Cell culture technology for influenza vaccines is not yet approved in the US, however part of the HHS contract support for Holly Springs includes funding for the development of a flu cell culture vaccine. The plant is planned to be running at full scale commercial production in 2013.

The Novartis Holly Springs facility can also start producing MF59 as early as December 2009. Results of the most recent clinical trials conducted with the Novartis MF59 adjuvanted cell culture-based vaccine have shown that it is possible to induce protective antibody levels against A(H1N1) infection within two weeks of administration of a single low-dose adjuvanted vaccine. MF59 has also been shown to provide cross-protection across similar strains of a H5N1 virus, which is an additional important element for a pre-pandemic vaccine given that mutations are a common feature of emerging influenza strains.

Daniel Vasella, chairman and CEO of Novartis, said: "We are proud to be one of the first companies to bring influenza cell culture as well as adjuvant technology to the United States.

"We have seen a great need to invest into new technologies for flu vaccines that will allow for quicker and more reliable production capacity. We are pleased to be working closely with the US government to build a world-class, state of the art manufacturing facility in the US that will change the way we manufacture influenza vaccines in the future."

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