Universal Stabilization Technologies, Inc.

Universal Preservation Technologies, Inc.

Quadrant Drug Delivery Limited

Avant Immunotherapeutics, Inc.

Bronshtein, Victor

Victor Bronshtein

Kevin R Bracken

David R Williams

Ronnie K Livers

John G Cambell

Lynn Linkowski

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.

Method for preserving biopharmaceuticals

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.

Polymeric compositions containing ambient-temperature stable biopharmaceuticals and methods for formulation thereof

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.

Compositions containing ambient-temperature stable, inactivated but therapeutically active biopharmaceuticals and methods for formulation thereof

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.

This invention relates to formulations comprising biological samples preserved as dry glassy powders and hydrophobic carriers, the formulations being adapted for the long-term storage and delivery of the bioactive materials, in particular viral and bacterial vaccines, vectors and cells, at ambient or higher temperatures, and to methods for preparing these formulations.

Preservation and formulation of bioactive materials for storage and delivery in hydrophobic carriers

The present invention discloses apparatus and methods of inducing bubble nucleation to overcome problems commonly associated with preservation by foam formation. Specifically, the invention relates to methods of using bubble nucleation in foam formation to preserve sensitive biological materials. Preferred methods of inducing bubble nucleation include, mixing, chamber rotation, crystals, and ultrasound.

Bulk drying and the effects of inducing bubble nucleation

This invention relates to formulations and methods for preserving sensitive biologicals, viruses, bacteria and eukaryotic cells by drying. More particularly, the invention relates to preservation mixtures containing viruses or cells and protectants, including a combination of a methylated monosaccharide and a disaccharide, or oligosaccharide, wherein the mixtures are adapted to stabilize these during dehydration and subsequent storage at ambient and higher temperature.

Formulation of preservation mixtures containing sensitive biologicals to be stabilized for ambient temperature storage by drying

This invention relates to barrier methods for preserving sensitive biological materials as a porous foam, subsequently crushing the foam to form a powder, and optionally formulating mixtures of preserved powdered biological materials. The invention also encompasses an apparatus for integrating the methods of foam formation and subsequent crushing of the preserved biological materials using barrier technology.

Industrial scale barrier technology for preservation of sensitive biological materials

The present invention relates to methods of forming a humidity barrier using fats or other materials that can form an amorphous coating for particles comprising sensitive biological materials in a dehydrated and/or a vitrified state. Since the hydrophobic coating may be sticky, a second hard-shell coating is applied to prevent the particles from sticking together. This approach would minimize exposure of the dried biological material to atmospheric moisture and the consequent loss of biological activity.

Methods of forming a humidity barrier for the ambient temperature preservation of sensitive biologicals

This invention discloses methods for the long-term preservation of industrial scale biological solutions and suspensions containing biologically active molecules, cells and small multicellular specimens at ambient temperatures by dehydration in amorphous very viscous liquid or glass state. The scale up method comprises the primary drying step of boiling under vacuum to form a mechanically-stable foam and a secondary drying step to increase the stability. Vitrification can subsequently be achieved by cooling the dried material to the storage temperature which is lower than the glass transition temperature.

Scalable long-term shelf preservation of sensitive biological solutions and suspensions

Industrial scale barrier technology for preservation of sensitive biological materials at ambient temperatures

A method of preserving sensitive biological dispersions, suspensions, emulsions and solutions by forming stable foams from fluid materials to be dehydrated, as an aid both to the drying of one or more biologically active substrates in the fluid and as an aid in preparing an easily divisible dried product suitable for further commercial use. The stable foams are formed by partially removing the water to form a viscous liquid and by further subjecting the reduced liquid to vacuum, to cause it to 'boil' during further drying at temperatures substantially lower than 100 degrees C. In other words, reduced pressure is applied to viscous solutions or suspensions of biologically active materials to cause the solutions or suspensions to foam during boiling, and during the foaming process further solvent removal causes the ultimate production of a stable open-cell or closed-cell foam.

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San Diego, CA, United States of America

Victor Bronshtein