Compositions containing ambient-temperature stable, inactivated but therapeutically active biopharmaceuticals and methods for formulation thereof
AssigneeUniversal Stabilization Technologies, Inc.
InventorVictor Bronshtein
Life of this patent
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Abstract
The disclosure concerns compositions containing inactivated but therapeutically active biopharmaceuticals, and methods for formulation thereof. Biopharmaceuticals are encapsulated and immobilized in dry amorphous carbohydrate-glass and irradiated for inactivation while in the dry state. The resulting compositions provide ambient-temperature stable, therapeutically active but inactivated biopharmaceuticals for use in vaccines and other applications.
Claims28
A method for formulation of a thermostable inactivated but potent (TIBP) vaccine, comprising:
- preserving one or more vaccines in a dry carbohydrate-glass, said preserving including:
- vacuum drying the vaccines for at least 6 hours at 40° C., or a higher temperature, to yield thermostable vaccines;
- wherein said thermostable vaccines are configured for storage and distribution without a need for refrigeration of the preserved vaccines;
- and
- subsequent to preserving the vaccines, inactivating the thermostable vaccines by irradiating said dry carbohydrate-glass containing the thermostable vaccines using a permeated ionizing radiation dose above 12.5 kGy.
A method for formulation of a thermostable composition comprising one or more inactivated but therapeutically active (IBTA) biopharmaceuticals, the method comprising:
- preserving the one or more biopharmaceuticals in a dry state, said preserving comprising:
- providing said one or more biopharmaceuticals in one of an aqueous solution or a hydrogel to form a first composition;
- partially freezing said first composition to form a two-phase state thereof, wherein said first composition comprises an amount of ice and an amount of liquid water in said two-phase state;
- vaporizing said first composition, said vaporizing comprising simultaneously applying vacuum and heat, wherein water is removed from said first composition through simultaneous boiling of the liquid, sublimation of ice, and evaporation of water molecules from a surface of the liquid;
- and
- continuing said vaporization to transform said first composition into a dry foam, wherein said dry foam forms an amorphous carbohydrate-glass matrix with said one or more biopharmaceuticals encapsulated and immobilized therein;
- following said preserving, irradiating said one or more biopharmaceuticals that are encapsulated and immobilized in the dry state to yield IBTA biopharmaceuticals, wherein said irradiating comprises:
- subjecting said amorphous carbohydrate-glass matrix containing the encapsulated and immobilized biopharmaceuticals to an electron beam;
- and
- forming said IBTA biopharmaceuticals into said composition, wherein said forming said IBTA biopharmaceuticals into said composition comprises at least one of:
- reconstituting said amorphous carbohydrate-glass matrix containing the IBTA biopharmaceuticals in an aqueous solution,
- combining said amorphous carbohydrate-glass matrix containing the IBTA biopharmaceuticals with a dry compound to form a therapeutic mixture, or
- micronizing said amorphous carbohydrate-glass matrix containing the IBTA biopharmaceuticals to form a therapeutic powder;
- wherein said irradiating comprises a radiation dose of at least 12 kGy.
A method for formulation of a therapeutic composition comprising inactivated but therapeutically active (IBTA) biopharmaceuticals, the method comprising:
- immobilizing one or more biopharmaceuticals in a dry amorphous carbohydrate-glass matrix;
- irradiating said biopharmaceuticals immobilized in the dry amorphous carbohydrate-glass matrix to inactivate the biopharmaceuticals yielding immobilized IBTA biopharmaceuticals;
- and
- forming said immobilized IBTA biopharmaceuticals into the therapeutic composition;
- wherein said irradiating comprises a radiation dose of at least 12 kGy.
Dependencies are inferred from the claim text.