Method of obtaining thermostable dried vaccine formulations
AssigneeMerck Sharp & Dohme Corp.
InventorsAkhilesh Bhambhani, Robert K. Evans, Jessica Sinacola, Morrisa Jones
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Abstract
This present invention relates to compositions and methods for stabilizing a dried vaccine formulations. In particular, the invention provides a method for producing a vaccine composition comprising the steps of providing an aqueous composition comprising a buffer, the vaccine components and between 17.5% w/w and 60% w/w of a non-polymeric sugar, freezing the composition, and applying microwave radiation under a pressure lower than atmospheric pressure in order to sublimate the composition and obtain a dried vaccine formulation. The invention also provides a product obtainable by this method.
Claims20
A method for drying a vaccine composition comprising a virus or viral protein subunit or virus-like particles comprising the steps of:
- a) providing an aqueous composition in a primary container comprising a buffer, the virus or viral protein subunit or virus-like particles, and between about 20% w/w and about 60% w/w of one or more non-polymeric sugars;
- b) freezing the composition, thereby forming at least one frozen body comprising the buffer in frozen form;
- and
- c) applying microwave radiation in a traveling wave format at a power in a range of between 0.5 and 8 KW/hr/Kg to the frozen body under a pressure below atmospheric pressure to produce a dried formulation.
Dependencies are inferred from the claim text.