Compositions containing ambient-temperature stable, inactivated but therapeutically active biopharmaceuticals and methods for formulation thereof
Inventors
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Publication Number
US-10632188-B2
Publication Date
2020-04-28
Expiration Date
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.
Core Innovation
The invention relates to ambient-temperature stable compositions comprising inactivated but therapeutically active (IBTA) biopharmaceuticals. The compositions include an IBTA ERAg333 virus immobilized in a dry amorphous carbohydrate-glass, with the virus characterized as being inactivated by irradiation while in the dry state.
A key problem addressed is the need for vaccine and inactivated biopharmaceutical formulations that can be maintained without cold chain, and the limitations of conventional drying approaches such as ED/FD/spray drying and their constraints on potency. Background information contrasts live and inactivated vaccine approaches and describes that conventional drying processes can impose limitations for maintaining desired therapeutic or immunologically active properties.
The approach described uses a drying format based on foam drying, including preservation by vaporization (PBV) and preservation by foam formulation (PFF), to form a dry amorphous carbohydrate-glass matrix, followed by electron-beam (EB) irradiation in the dry state. The document states that irradiating in the dry state helps avoid effects associated with liquid-state exposure, and it reports that potency retention is achieved with less than about 0.5 log potency loss after extended ambient storage.
Claims Coverage
The document provides two independent claims (clm-00001 and clm-00005). Each independent claim centers on a composition that immobilizes an IBTA ERAg333 virus in a dry amorphous carbohydrate-glass, characterizes the virus as being irradiated in the dry state for inactivation, and requires ambient-temperature stability with less than 0.5 logs potency loss after one year across a specified temperature range; one independent claim additionally fixes the carbohydrate-glass formulation as two parts sucrose and one part methylglucoside.
Dry amorphous carbohydrate-glass immobilization of inactivated-but-therapeutically-active ERAg333 virus with ambient-temperature stability
An amount of inactivated but therapeutically active (IBTA) ERAg333 virus immobilized in a dry amorphous carbohydrate-glass, wherein the IBTA ERAg333 virus is characterized as being inactivated by irradiation while in the dry state and having a loss of potency less than 0.5 logs after one year of storage at a storage temperature between -20 °C and 37 °C, and wherein the composition is ambient-temperature stable.
Two-part sucrose and one-part methylglucoside carbohydrate-glass for EB-inactivated dry-state ERAg333 IBTA composition
An amount of inactivated but therapeutically active (IBTA) ERAg333 virus immobilized in a dry amorphous carbohydrate-glass, the carbohydrate-glass comprising two-parts sucrose and one-part methylglucoside, wherein the IBTA ERAg333 virus is characterized as being inactivated by irradiation while in the dry state and having a loss of potency less than 0.5 logs after one year of storage at a storage temperature between -20 °C and 37 °C.
Across the independent claims, the main inventive coverage is the combination of immobilizing an IBTA ERAg333 virus in a dry amorphous carbohydrate-glass, inactivation by irradiation while in the dry state, and maintaining potency with less than 0.5 log loss after one year across -20 °C to 37 °C for ambient-temperature stability; one independent claim additionally specifies the carbohydrate-glass as two parts sucrose and one part methylglucoside.
Stated Advantages
Ambient-temperature stable composition with less than 0.5 log potency loss after one year of storage at a storage temperature between -20 °C and 37 °C.
Reduces reliance on cold chain for maintaining potency of an inactivated but therapeutically active (IBTA) virus formulation.
Enables potency retention while using irradiation in the dry state.
Documented Applications
Ambient-temperature stable inactivated-but-therapeutically-active (IBTA) rabies virus ERAg333 compositions as vaccine-like formulations.
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