New plant will be ready to respond to flu pandemic as early as 2011.

Novartis officially opened what is says is the first large-scale cell culture flu vaccine and adjuvant manufacturing facility in the U.S. The $1 billion facility in Holly Springs, NC, results from a partnership between Novartis and the U.S. Department of Health and Human Services. The deal also requires Novartis to provide two commercial-scale annual lots of prepandemic vaccine for a minimum of three years. The HHS retains options to purchase additional flu vaccines over 17 years.

Novartis reports that although the FDA has yet to approve a cell culture-based flu vaccine, part of the HHS contract support for the Holly Springs facility includes funding for development of a cell culture flu vaccine. If such a vaccine is licensed for use in an emergency, the facility will be ready to respond to a pandemic by 2011 and is expected to be up to full commercial-scale production in 2013.

The plant will also start manufacturing Novartis’ MF59® adjuvant by the end of this year. Although not yet licensed in the U.S., the vaccine adjuvant is currently undergoing trials. It is already a component of the EU-sanctioned seasonal flu vaccine Fluad® and the AH1N1 vaccines Focetria®, which received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use in September, and Celtura®, which was licensed in Germany and Switzerland earlier this month.

The manufacturing facility will change the way flu vaccines are manufactured in the future, according to Daniel Vasella, Novartis chairman and CEO. “We have seen a great need to invest into new technologies for flu vaccines that will allow for quicker and more reliable production capacity.”

In October, Novartis confirmed completing its entire shipment of 27 million doses of the seasonal flu vaccine Fluvirin  to the U.S. Also in October the company reported having shipped over 7.5 million doses of its influenza AH1N1 vaccine ready-to-use, and expected 25 to 30 million doses of unadjuvanted vaccine to become available in prefilled syringes and multidose vials by the end of November.

Novartis’ existing cell culture-based flu vaccine plant in Marburg, Germany, is licensed to produce the seasonal cell culture-based vaccine Optaflu® and also the H1N1 pandemic vaccine Celtura.

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