Novartis has successfully completed the production of the first batch of influenza A(H1N1) vaccine, weeks ahead of expectations. Cell-based manufacturing technology[1] 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[1].

“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.”

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Baxter International Inc. (NYSE: BAX) announced that it has completed testing and evaluation of the A/H1N1 influenza virus and is now in full-scale production of a commercial A/H1N1 vaccine using its Vero cell culture technology. Baxter received an A/H1N1 strain from the U.S. Centers for Disease Control and Prevention [a World Health Organization (WHO) Collaborating Center] in early May and is diligently working to deliver a pandemic vaccine for use as early as July.

WHO raised the pandemic alert level to phase 6, indicating a global influenza pandemic involving the 2009 A/H1N1 strain. Baxter is in contact with WHO and other global public health authorities regarding the pandemic. A number of national public health authorities have existing pandemic agreements with Baxter that allow them to place orders for a vaccine now that a pandemic has been declared by WHO. These public health authorities will be evaluating their needs to determine their orders for vaccine supply. Despite the company’s existing obligations to supply vaccine under a pandemic phase 6 alert, Baxter is also committed to working with WHO to allocate a portion of the company’s commercial production to address global public health issues deemed most urgent.

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