PATH receives follow-on funding to scale up production of thermostable influenza vaccines

February 12, 2013 by PATH

Amy Wales, PATH, 206.302.4689,

Seattle, February 12, 2013—The Strategic Science and Technology group of the Biomedical Advanced Research and Development Authority (BARDA), a division of the US Department of Health and Human Services, has awarded PATH US$2.5 million in follow-on funding to advance the development of thermostable influenza vaccines, helping to extend product shelf life and ease logistics during vaccine introduction and rapid deployment.

The typical stability of subunit and live attenuated influenza vaccines is less than two weeks at 37°C. The lead thermostable H1N1 subunit and live attenuated influenza vaccine (LAIV) formulations developed by PATH and Aridis Pharmaceuticals during an earlier period of project work have proven to be stable at 37°C for over nine months and five months, respectively, which represent significant improvements over the control formulations. Under the new funding from BARDA, the stability of these improved formulations will continue to be monitored by PATH and Aridis Pharmaceuticals over the course of an ongoing two-year study.

The formulations with improved stability were prepared using excipients with a proven safety record and produced using lyophilization (freeze-drying), spray-drying, and foam-drying processing methods. In the next phase of the project, Aridis Pharmaceuticals and PATH will evaluate the applicability of these formulation technologies to additional subunit and LAIV strains. PATH will also collaborate with Aeras to scale up the production of the leading thermostable H1N1 subunit influenza vaccine formulations by lyophilization, the processing method of choice for heat-sensitive vaccines when a reasonable shelf life cannot be achieved in a liquid product format. As part of this effort, PATH and Aeras will develop a scalable production process and make it available for technology transfer, enabling vaccine manufacturers to produce seasonal and pre-pandemic vaccines with robust stability—helping to ensure vaccine performance and effectiveness under a variety of temperature conditions.

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