COMPOSITIONS CONTAINING AMBIENT-TEMPERATURE STABLE, INACTIVATED BUT THERAPEUTICALLY ACTIVE BIOPHARMACEUTICALS & METHODS FOR FORMULATION THEREOF

摘要

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.

主权项

1. 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; the thermostable vaccines being modified for long-term stability at all ambient temperatures between −20° C. to +37° C.; wherein said thermostable vaccines are configured for long-term stability 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 12.5kGa.