Novartis successfully demonstrates capabilities of cell-based technology for A(H1N1) vaccine

Novartis has successfully completed the production of the first batch of influenza A(H1N1) vaccine. Cell-based manufacturing technology allows vaccine production to be initiated once a pandemic virus strain is identified without the need to adapt the virus strain to grow in eggs. This advance has cut weeks off the time required to begin vaccine production, the company says.

Novartis has successfully completed the production of the first batch of influenza A(H1N1) vaccine. Cell-based manufacturing technology allows vaccine production to be initiated once a pandemic virus strain is identified without the need to adapt the virus strain to grow in eggs. This advance has cut weeks off the time required to begin vaccine production, the company says.

This batch of ten litres of wild type influenza A(H1N1) vaccine monobulk will be used for pre-clinical evaluation and testing and is also being considered for use in clinical trials. The company says it demonstrates the value of the cell-based production approach, which Novartis is also using with reassortant influenza A(H1N1) seed.

The Novartis cell-culture vaccine production facility is located in Marburg, Germany, which has the potential to produce millions of doses of vaccine each week.

A second facility, in collaboration with the US Department of Health and Human Services, is being built in Holly Springs, North Carolina.

"The speed advantages of our cell-based production approach and our unwavering commitment to address this public health emergency have resulted in our ability to provide the fastest possible response to this outbreak," said Dr Andrin Oswald, ceo of Novartis Vaccines and Diagnostics.

Based on the success with the wild type, Novartis expects to be able to achieve rapid scale-up of influenza A(H1N1) vaccine manufacture with reassortant seed, which was provided by the US Centres for Disease Control and Prevention (CDC) in May. The company plans to start clinical trials with that vaccine in July and expects it to be licensed in the autumn of 2009.

More than 30 governments have asked Novartis to supply them with influenza A(H1N1) vaccine ingredients. These are a combination of pre-existing pandemic vaccine supply agreements and new requests for vaccines across all of Novartis" production platforms including egg-based manufacturing. The US Department of Health and Human Service's US$289m order in May 2009 with Novartis was the largest of the US government's commitments to influenza A(H1N1) vaccine ingredients.

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