New flu cell culture vaccine manufacturing technology promises many advantages over traditional egg-based production, including greater reliability and a reduction in production time.
The total investment of approximately $600 million includes a recent $220 million award from the US Department of Health and Human Services. Construction is expected to begin in 2007.
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.
Novartis also recently filed a submission with European regulators for the first cell culture-derived influenza vaccine. The company is also making additional investments in its Marburg, Germany, site to expand capacity for flu cell culture vaccines production in Europe.
“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.