Novartis inaugurates large-scale US based cell-culture influenza vaccine manufacturing facility
Facility designed to supply 150 million doses of pandemic vaccine within 6 months of influenza pandemic declaration
Novartis officially inaugurated the US's first ever 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). It is the first of its kind in the United States and highlights an important milestone in efforts to improve influenza vaccine manufacturing technology in the US and enhance domestic pandemic preparedness.
"We are proud to be one of the first companies to bring influenza cell culture as well as adjuvant technology to the United States," said Daniel Vasella, CEO and Chairman of Novartis. "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."
The total investment in the facility is nearly USD 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 modern, cell culture-based manufacturing technology. Cell culture-based production operations are cleaner, can be scaled up more quickly to respond to a pandemic and do not rely on eggs for rapid response to a pandemic. 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. If licensed in an emergency, the facility will be ready to respond to a pandemic as early as 2011. The plant is planned to be running at full scale commercial production in 2013.
The Novartis Holly Springs facility can also start producing MF59®, the Novartis proprietary adjuvant, as early as December 2009. Although not yet approved in the US, studies with adjuvants are currently underway in the US. 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.
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Topic world Cell culture technology
Cell culture technology is a central pillar in biotechnological and pharmaceutical research and development. It enables the growth and maintenance of cells under controlled laboratory conditions, providing a window into the molecular and cellular processes of life.
Topic world Cell culture technology
Cell culture technology is a central pillar in biotechnological and pharmaceutical research and development. It enables the growth and maintenance of cells under controlled laboratory conditions, providing a window into the molecular and cellular processes of life.
