Abstract: The disclosure concerns methods for executing PBV protocols to preserve biopharmaceuticals using a conventional lyophilizer. Also described are steps for maintaining isolation of a biopharmaceuticals for achieving aseptic drying using the conventional lyophilizer. As a collateral benefit, the invention provides good manufacturing practice (GMP) compliant methods for achieving aseptic drying of biopharmaceutical compositions using a conventional lyophilizer disposed outside of a clean-room area. Finally, methods and formulations str disclosed for preserving biopharmaceuticals suitable for mucosal or transdermal delivery to a patient.
Type:
Grant
Filed:
July 11, 2018
Date of Patent:
August 2, 2022
Assignee:
Universal Stabilization Technologies, Inc.
Abstract: Biopharmaceuticals, such as vaccine agents and probiotics, are encapsulated in carbohydrate-glass particles and embedded in an amorphous polymer substrate to produce polymeric compositions containing ambient-temperature stable biopharmaceuticals for syringeless administration to patients such as via dissolvable films, micro-needle patches and similar medical delivery devices. The amorphous polymer substrate is soluble in both water and a volatile organic solvent, yet the carbohydrate-glass particles are insoluble in the volatile organic solvent.
Abstract: The disclosure concerns methods for executing PBV protocols to preserve biopharmaceuticals using a conventional lyophilizer. Also described are steps for maintaining isolation of a biopharmaceuticals for achieving aseptic drying using the conventional lyophilizer. As a collateral benefit, the invention provides good manufacturing practice (GMP) compliant methods for achieving aseptic drying of biopharmaceutical compositions using a conventional lyophilizer disposed outside of a clean-room area. Finally, methods and formulations str disclosed for preserving biopharmaceuticals suitable for mucosal or transdermal delivery to a patient.
Type:
Application
Filed:
July 11, 2018
Publication date:
May 20, 2021
Applicant:
Universal Stabilization Technologies, Inc.
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.
Type:
Grant
Filed:
June 30, 2017
Date of Patent:
April 28, 2020
Assignee:
UNIVERSAL STABILIZATION TECHNOLOGIES, INC.
Abstract: The disclosure concerns vaccines; and more particularly, highly antigenic thermostable vaccines configured for mucosal or transdermal delivery without reconstitution. Also disclosed are methods for formulating the highly antigenic thermostable vaccines.
Type:
Application
Filed:
April 30, 2018
Publication date:
March 19, 2020
Applicant:
Universal Stabilization Technologies, Inc.
Abstract: Biopharmaceuticals, such as vaccine agents and probiotics, are encapsulated in carbohydrate-glass particles and embedded in an amorphous polymer substrate to produce polymeric compositions containing ambient-temperature stable biopharmaceuticals for syringeless administration to patients such as via dissolvable films, micro-needle patches and similar medical delivery devices. The amorphous polymer substrate is soluble in both water and a volatile organic solvent, yet the carbohydrate-glass particles are insoluble in the volatile organic solvent.
Abstract: Biopharmaceuticals, such as vaccine agents and probiotics, are encapsulated in carbohydrate-glass particles and embedded in an amorphous polymer substrate to produce polymeric compositions containing ambient-temperature stable biopharmaceuticals for syringeless administration to patients such as via dissolvable films, micro-needle patches and similar medical delivery devices. The amorphous polymer substrate is soluble in both water and volatile organic solvents, yet the carbohydrate-glass particles are insoluble in organic solvents. A method for formulation of the polymeric compositions containing ambient-temperature stable biopharmaceuticals includes combining biopharmaceuticals encapsulated in carbohydrate-glass particles with polymer in organic solvent and evaporating the organic solvent to yield a water soluble polymeric composition containing ambient-temperature stable biopharmaceuticals.
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.
Type:
Application
Filed:
June 30, 2017
Publication date:
May 10, 2018
Applicant:
Universal Stabilization Technologies, Inc.
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.
Type:
Grant
Filed:
March 23, 2015
Date of Patent:
August 29, 2017
Assignee:
Universal Stabilization Technologies, Inc.
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.
Type:
Application
Filed:
March 23, 2015
Publication date:
March 30, 2017
Applicant:
Universal Stabilization Technologies, Inc.
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.
Type:
Application
Filed:
March 23, 2015
Publication date:
March 31, 2016
Applicant:
Universal Stabilization Technologies, Inc.