摘要:
A method of formulating high ambient temperature (room temperature and above) stable biologics (biologically active macromolecules, enzymes, serums, vaccines, viruses, pesticides, drug delivery systems, liposomes, cells suspensions, sperm, erythrocytes, other blood cells, stem cells, multicellular tissues, skin, heart valves) including secondary drying comprising at least two steps of stability drying at elevated temperature: 35° C., 40° C., 45° C., 50° C., and higher temperatures. The method could be applied to stabilize biologics encapsulated in alginate gel microspheres for better oral delivery. The method encompasses the following: microspheres are formulated using a cryo-encapsulation procedure comprised of mixing drops of frozen preservation mixture (To form the preservation mixture, biologics are mixed with preservation solutions containing sodium alginate.) with frozen drops of a calcium solution (i.e. calcium gluconate) and subsequent warming to form the gel particles.
摘要:
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.
摘要:
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.
摘要:
Significant research is being done to develop and improve delivery mechanisms for biopharmaceuticals and vaccines, including pulmonary (inhalation), nasal, transdermal, and oral alternatives. Market projections indicate that the delivery of proteins and vaccines by inhalation and oral formulation has become and will continue to be increasingly important. These delivery mechanisms, to be effective, will require better stabilization of the biologicals so that they can maintain potency and effectiveness at ambient temperatures for extended periods of time. The novel Preservation by Vaporization (PBV) Technology described herein provides cost-effective and efficient industrial scale stabilization of proteins, viruses, bacteria, and other sensitive biologicals, thereby allowing a production of products that are not possible to be produced by existing methods. The suggested new PBV process comprises primary drying under vacuum from a partially frozen state (i.e. slush) at near subzero temperatures followed by stability drying at elevated temperatures (i.e., above 40 degrees Celsius). The new suggested method can be performed aseptically in unit doze format (in vials) and/or in bulk format (in trays, bags, or other containers). The drying can be performed as a continuous load process in a manifold vacuum dryer comprising a plurality (e.g., 30) of vacuum chambers attached to a condenser during the drying.
摘要:
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.
摘要:
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.
摘要:
The present invention relates to techniques for loading cells with desiccation protectants comprising non-metabolizable and non-reducing carbohydrate analogs. Specifically, competent bacterial cells can be preserved using the loading techniques provided herein.
摘要:
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.
摘要:
Significant research is being done to develop and improve delivery mechanisms for biopharmaceuticals and vaccines, including pulmonary (inhalation), nasal, transdermal, and oral alternatives. Market projections indicate that the delivery of proteins and vaccines by inhalation and oral formulation has become and will continue to be increasingly important. These delivery mechanisms, to be effective, will require better stabilization of the biologicals so that they can maintain potency and effectiveness at ambient temperatures for extended periods of time. The novel Preservation by Vaporization (PBV) Technology described herein provides cost-effective and efficient industrial scale stabilization of proteins, viruses, bacteria, and other sensitive biologicals, thereby allowing a production of products that are not possible to be produced by existing methods. The suggested new PBV process comprises primary drying under vacuum from a partially frozen state (i.e. slush) at near subzero temperatures followed by stability drying at elevated temperatures (i.e., above 40 degrees Celsius). The new suggested method can be performed aseptically in unit doze format (in vials) and/or in bulk format (in trays, bags, or other containers). The drying can be performed as a continuous load process in a manifold vacuum dryer comprising a plurality (e.g., 30) of vacuum chambers attached to a condenser during the drying.
摘要:
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.