Thermostable uv inactivated vaccines and other biopharmaceuticals
AssigneeUniversal Stabilization Technologies, Inc.
InventorsVictor Bronshtein, Min-Xuan Wang
Life of this patent
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Abstract
This invention describes method for inactivation of microorganisms in thermostable dry formulations at ambient temperatures (AT) using UV light irradiation. According to this method microorganisms are inactivated at ambient temperatures (AT) in dry formulations where the amount of free radicals formed is relatively small and damage of nucleic acids is the main cause for the microorganism's death. The method will allow production of thermostable inactivated vaccines from wild type and live attenuated microorganisms, thermostable inactivated microbiome products, and thermostable sterilized none-live blood components, therapeutic proteins, antibodies and other fragile biopharmaceuticals.
Claims64
A method of producing a dry thermostable sterilized biopharmaceuticals, comprising:
- stabilizing the biopharmaceutical at ambient temperatures using drying;
- and
- subsequently exposing the stabilized biopharmaceutical to ultraviolet radiation at ambient temperatures having a dose between and inclusive of 0.2 J/cm2 and 10 J/cm2 to decrease viability of the microorganisms.
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A method of producing a dry thermostable sterilized biopharmaceutical using Preservation by Vaporization (PBV), comprising:
- combining a microorganism suspension and a preservation solution to form a preservation mixture, the microorganism suspension comprising live virions or cellular microorganisms, the preservation solution comprising amino acids, one or more non-reducing disaccharides, and one or more monosaccharide derivatives and/or sugar alcohols;
- drying the microorganism suspension by vaporization under vacuum to form a mechanically-stable glassy foam, said mechanically-stable glassy foam comprising:
- less than five percent residual water content, and
- a glass transition temperature greater than an ambient temperature at which the material will be stored,
- wherein the live virions viruses or cellular microorganisms are immobilized in the mechanically-stable glassy foam;
- and
- exposing the mechanically-stable glassy foam at ambient temperatures to an ultraviolet radiation having a wavelength from 280 to 400 nm and a dose between and inclusive of 0.2 J/cm2 and 10 J/cm2 to sterilize the biopharmaceutical.
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Dependencies are inferred from the claim text.