Novartis announced plans to build the first cell culture-derived influenza vaccines manufacturing plant in the United States at a site in Holly Springs, North Carolina, with construction expected to begin in 2007.
Novartis also announced the first European Union submission of a cell culture-derived influenza vaccine, also commonly referred to as "flu cell culture influenza vaccines." The submission to the Committee for Medicinal Products for Human Use (CHMP) was made in June after the successful completion of Phase III clinical studies. Novartis is also making additional investments in its Marburg, Germany, site to expand capacity for flu cell culture vaccines production in Europe.
Novartis is seeking to become the first to commercially produce and market flu cell culture vaccines for European markets. US clinical studies, which began in 2005, are ongoing. The vaccines for the EU and US clinical trials have been produced at the Novartis site in Marburg, where the product was developed.
"We are taking the lead in moving flu cell culture vaccine manufacturing closer to a commercial reality now that the site for a US manufacturing plant has been chosen and the first EU submission for a flu cell culture vaccine have been completed," said Dr. Daniel Vasella, Chairman and CEO of Novartis. "Novartis is pioneering this innovative vaccine technology to bring reliability and flexibility of the manufacturing process to a next level and be able to meet the growing need for seasonal influenza vaccines and to quickly respond to a potential pandemic influenza threat once the factory has been completed."
A total investment of approximately USD 600 million, which includes a recent USD 220 million award from the US Department of Health and Human Services, is planned to complete the Holly Springs site.
Once completed and approved for commercial production, the planned Holly Springs site 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 site is planned to have a capacity of up to 150 million monovalent doses annually within six months of a pandemic declaration.
New flu cell culture vaccine manufacturing technology promises many advantages over traditional egg-based production, including greater reliability and a reduction in production lead-time. These advantages could be pivotal in the event of an influenza pandemic. As flu cell culture vaccines move toward commercialization, egg-based influenza vaccine production is expected to continue playing a critical role in reducing the impact of influenza outbreaks and prepare for a potential influenza pandemic.
Cell culture-derived influenza vaccines use modern biotechnology cell cultures rather than chicken eggs for primary production. Current egg-based influenza vaccines production requires several months of logistics for ordering and receiving eggs. This lead time can hinder the response to unanticipated demands such as the discovery of pandemic strains, production failures and seasonal influenza virus strain changes. In contrast, flu cell culture production enables flexible, faster start-up of vaccine manufacturing, and does not depend upon the availability of eggs, providing a particularly important advantage in the event of an influenza pandemic.