U.S. Patent Awarded for Freeze-Dried Vaccine Formulation

U.S. Patent and Trademark Office (A. Kotok)

9 September 2014. The technology making possible production and shipping of vaccines in a stable freeze-dried state received U.S. patent protection. Patent no. 8,808,710 was awarded last month by the U.S. Patent and Trademark Office to four inventors and assigned to University of Colorado. Soligenix Inc. in Princeton, New Jersey licensed the technology from University of Colorado in January 2011.

The technology makes it possible for vaccines to be produced in freeze-dried form with aluminum adjuvants, or boosters, and remain potent enough under extremes of heat to generate an immune response. Aluminum salts added to some vaccines, such as diphtheria and tetanus, can improve their ability to produce antibodies. The technology in the patent offers a method for producing and storing vaccines that do not require continuous refrigeration through the supply chain, thus sharply reducing costs and increasing their availability in remote regions.

The patent covers the ingredients in a freeze-dried vaccine formulation and methods in the production cycle such as controlling particle size, selecting aluminum salts for adjuvants, creating a liquid state for the vaccine compound, freezing and freeze-drying the compound, and reconstituting the vaccine into a liquid state. While the patent specifically mentions botulism as a target for the technology, it also claims as part of the composition of vaccines, a wide range of antigens covering potential bioweapons (e.g., anthrax, ricin), influenza viruses, cancer viruses, and many other infectious disease pathogens.

Development of the vaccine technology that Soligenix calls ThermoVax is a joint venture with SRI International, University of Kansas, Tulane National Primate Center, and the New York State Department of Health. The development work is funded by a $9.4 million grant from the National Institute of Allergy and Infectious Diseases, an agency of National Institutes of Health.

Soligenix says ThermoVax is used to produce its engineered ricin vaccine called RiVax and VeloVax to protect against anthrax exposure. The technology is also expected to make it easier for the U.S. Biomedical Advanced Research and Development Authority or BARDA to stockpile vaccines for as part of the nation’s biodefense capabilities. The technology can be applied as well to commercial vaccine production and logistics, where the company cites industry data from 2010 showing 98 percent of all vaccines, valued at $20.6 billion, are shipped using refrigerated transport and storage.

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