Novartis has announced plans to build the first cell culture-derived influenza vaccines manufacturing plant in the U.S. at a site in Holly Springs, NC. Construction of the $600 million site is expected to begin in 2007. At the same time, Novartis announced the first EU submission of a cell culture-derived influenza vaccine. The submission was made in June. U.S. clinical trials started in 2005 and are ongoing.

“We are taking the lead in moving flu cell culture vaccine manufacturing closer to a commercial reality now that the site for a U.S. manufacturing plant has been chosen and the first EU submission for a flu cell culture vaccine have been completed,” said Dr. Daniel Vasella, Novartis’ chairman and chief executive officer. “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 $600 million, including a recent $220 million award from the Department of Health and Human Services, is planned to complete the Holly Springs site. Novartis is also making additional investments in its site in Marburg, Germany to expand capacity for flu cell culture vaccines production in Europe. The vaccines for the EU and U.S. clinical trials were produced at the Marburg site, where the product was developed.

Once completed and approved for commercial production, the planned NC site is expected to annually produce up to 50 million doses of seasonal trivalent flu vaccines, which will be for use in the U.S., according to Novartis. In the event of an flu pandemic, the site is planned to have a capacity of up to 150 million monovalent doses annually within six months of a pandemic declaration.