Dry storage stabilizing composition for biological materials
First Claim
1. A dry glassy stabilizing composition, comprising a bioactive material, one or more disaccharides at 10-90%, one or more oligosaccharides at 1-10%, one or more polysaccharides at 0.1-10%, one or more hydrolyzed proteins at 0.5-40%, and one or more carboxylic acid salts, each percentage based on the total weight of the composition, wherein the one or more carboxylic acid salts are selected from the group consisting of salts of lactic acid, ascorbic acid, maleic acid, oxalic acid, malonic acid, malic acid, succinic acid, citric acid, gluconic acid, glutamic acid, and a mixture thereof, and wherein the bioactive material consists of a live microorganism.
0 Assignments
0 Petitions
Accused Products
Abstract
The present invention includes compositions and drying methods for preserving sensitive bioactive materials, such as peptides, proteins, hormones, nucleic acids, antibodies, drugs vaccines, yeast, bacteria (probiotic or otherwise), viruses and/or cell suspensions, in storage. The compositions include a carbohydrates component and a glass enhancer component, wherein the carbohydrate component includes a mixture of di-, oligo- and polysaccharides and the glass enhancer includes ions of organic acid and protein hydrolysates. The composition is prepared by dispersing all the solid components in a solution and then snap-frozen to form small beads, strings or droplets. The preferred drying method of the frozen beads, strings or droplets is initiated by a short purging and structure stabilizing step of the frozen particles under a vacuum pressure of less than <2000 mTORR followed by a primary drying step under vacuum pressure of more than >2000 mTORR and at a desired temperature. During the secondary and final drying step of the material a full vacuum pressure and elevated temperature are applied, to achieve a final desirable water activity of the dry material.
-
Citations
24 Claims
- 1. A dry glassy stabilizing composition, comprising a bioactive material, one or more disaccharides at 10-90%, one or more oligosaccharides at 1-10%, one or more polysaccharides at 0.1-10%, one or more hydrolyzed proteins at 0.5-40%, and one or more carboxylic acid salts, each percentage based on the total weight of the composition, wherein the one or more carboxylic acid salts are selected from the group consisting of salts of lactic acid, ascorbic acid, maleic acid, oxalic acid, malonic acid, malic acid, succinic acid, citric acid, gluconic acid, glutamic acid, and a mixture thereof, and wherein the bioactive material consists of a live microorganism.
-
7. A method for preparing a dry glassy stabilizing composition comprising a biological material, one or more disaccharides at 10-90%, one or more oligosaccharides at 1-10%, one or more polysaccharides at 0.1-10%, one or more hydrolyzed proteins at 0.5-40%, and one or more carboxylic acid salts, each percentage based on the total weight of the composition, wherein the one or more carboxylic acid salts are selected from the group consisting of salts of lactic acid, ascorbic acid, maleic acid, oxalic acid, malonic acid, malic acid, succinic acid, citric acid, gluconic acid, glutamic acid, and a mixture thereof, wherein the bioactive material consists of a live microorganism, comprising:
- (a) combining the bioactive material with the one or more disaccharides, the one or more oligosaccharides, the one or more polysaccharides, the one or more hydrolyzed proteins, and the one or more carboxylic acid salts in an aqueous solvent to form a slurry;
(b) snap-freezing the slurry in liquid nitrogen to form solid frozen particles in a form of beads, droplets or strings; (c) primary drying the frozen particles by evaporation under vacuum and at a temperature above the freezing temperature of the frozen particles to form a primarily dried formulation; and (d) secondary drying the primarily dried formulation at higher vacuum and at a temperature of 20°
C. or higher for a time sufficient to reduce the water activity thereof;
whereby the dry stabilizing composition is obtained. - View Dependent Claims (8, 9, 10, 11, 12, 13, 14, 22, 23, 24)
- (a) combining the bioactive material with the one or more disaccharides, the one or more oligosaccharides, the one or more polysaccharides, the one or more hydrolyzed proteins, and the one or more carboxylic acid salts in an aqueous solvent to form a slurry;
Specification