Novartis has successfully completed the production of the first batch of influenza A(H1N1) vaccine, weeks ahead of expectations. 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, as with traditional vaccine technologies. This advance has cut weeks off the time required to begin vaccine production. This first batch of ten liters 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. It demonstrates the value of the cell-based production approach, that is also being used by Novartis with reassortant influenza A(H1N1) seed.

The Novartis state of the art cell-culture vaccine production facility is located in Marburg, Germany. As well as speed, another advantage of cell-based production is the ability to rapidly increase production, so the facility 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 under construction 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. "This achievement is also a testament to the technical skills and innovation of Novartis Vaccines and Diagnostics people and our partners. I believe it highlights our reputation as a leader in influenza vaccine research, development and production."

Based on this 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 Centers for Disease Control and Prevention (CDC) on May 27th. The company plans to start clinical trials with that vaccine in July and expects licensure in the fall of 2009.