Desiccated Biologics And Methods Of Preparing The Same

Abstract

The present invention provides compositions comprising desiccated biologics comprising a cell, protein, virus, nucleic acid, carbohydrate, or lipid, or any combination thereof, along with at least one membrane penetrable sugar, and at least one membrane impenetrable sugar, wherein the moisture content is from 5% to 95%, and to methods of preparing the same, and to methods of treating animals using the same.

1 . A composition comprising:
 one or more biologics;   one or more membrane penetrable sugars; and   one or more membrane impenetrable sugars;   wherein the moisture content of the composition is from about 5% to about 95%.   
   
   
       2 . The composition of  claim 1  wherein the biologic is a cell. 
   
   
       3 . The composition of  claim 2  wherein the cell is anucleated. 
   
   
       4 . The composition of  claim 3  wherein the anucleated cell is a platelet or red blood cell. 
   
   
       5 . The composition of  claim 2  wherein the cell is nucleated. 
   
   
       6 . The composition of  claim 5  wherein the nucleated cell is a white blood cell, a stem cell, a stem cell progenitor cell, a gamete, a gamete progenitor cell, a hepatocyte, a muscle cell, a kidney cell, an endothelial cell, an epithelial cell, an erythroblast, a leukoblast, a chondroblast, or a pancreatic cell. 
   
   
       7 . The composition of  claim 1  wherein the biologic is a protein, virus, nucleic acid, carbohydrate, or lipid. 
   
   
       8 . The composition of  claim 1  wherein the membrane penetrable sugar is trehalose. 
   
   
       9 . The composition of  claim 1  wherein the membrane impenetrable sugar is dextran. 
   
   
       10 . The composition of  claim 1  wherein the moisture content is from about 15% to about 40%. 
   
   
       11 . The composition of  claim 1  wherein the moisture content is from about 20% to about 25%. 
   
   
       12 . The composition of  claim 1  wherein the biologic is a platelet, the membrane penetrable sugar is trehalose, the membrane impenetrable sugar is dextran, and the moisture content is about 15%. 
   
   
       13 . The composition of  claim 1  wherein the biologic is a red blood cell, the membrane penetrable sugar is trehalose, the membrane impenetrable sugar is dextran, and the moisture content is about 25%. 
   
   
       14 . The composition of  claim 1  wherein the biologic is a white blood cell, the membrane penetrable sugar is trehalose, the membrane impenetrable sugar is dextran, and the moisture content is about 50%. 
   
   
       15 . A method of preserving a biologic comprising:
 contacting the biologic with at least one membrane penetrable sugar and at least one membrane impenetrable sugar;   optionally, contacting the biologic with a fixative agent; and   drying the biologic by vacuum desiccation to a final moisture content of from about 5% to about 90%.   
   
   
       16 . The method of  claim 15  wherein the biologic is a cell. 
   
   
       17 . The method of  claim 16  wherein the cell is anucleated. 
   
   
       18 . The method of  claim 17  wherein the anucleated cell is a platelet or red blood cell. 
   
   
       19 . The method of  claim 16  wherein the cell is nucleated. 
   
   
       20 . The method of  claim 19  wherein the nucleated cell is a white blood cell, a stem cell, a stem cell progenitor cell, a gamete, a gamete progenitor cell, a hepatocyte, a muscle cell, a kidney cell, an endothelial cell, an epithelial cell, an erythroblast, a leukoblast, a chondroblast, or a pancreatic cell. 
   
   
       21 . The method of  claim 15  wherein the biologic is a protein, virus, nucleic acid, carbohydrate, or lipid. 
   
   
       22 . The method of  claim 15  wherein the membrane penetrable sugar is trehalose. 
   
   
       23 . The method of  claim 15  wherein the membrane impenetrable sugar is dextran. 
   
   
       24 . The method of  claim 15  wherein the moisture content is from about 15% to about 40%. 
   
   
       25 . The method of  claim 15  wherein the moisture content is from about 20% to about 25%. 
   
   
       26 . The method of  claim 15  wherein the fixative agent is glutaraldehyde or paraformaldehyde. 
   
   
       27 . The method of  claim 15  wherein the biologic is dried by vacuum desiccation at temperatures ranging from about 0° C. to about 40° C. for about 1 hours to about 4 hours. 
   
   
       28 . The method of  claim 27  wherein the biologic is dried by vacuum desiccation at temperatures ranging from about 32° C. to about 34° C. for about 3 hours. 
   
   
       29 . The method of  claim 15  further comprising storing the biologic in a vacuum sealed container in the presence or absence of a desiccant. 
   
   
       30 . The method of  claim 15  further comprising rehydrating the biologic. 
   
   
       31 . The method of  claim 30  wherein the rehydration comprises contacting the biologic with water, optionally followed by saline. 
   
   
       32 . The method of  claim 15  wherein the biologic is a platelet, the membrane penetrable sugar is trehalose, the membrane impenetrable sugar is dextran, and the moisture content is about 15%. 
   
   
       33 . The method of  claim 15  wherein the biologic is a red blood cell, the membrane penetrable sugar is trehalose, the membrane impenetrable sugar is dextran, and the moisture content is about 25%. 
   
   
       34 . The method of  claim 15  wherein the biologic is a white blood cell, the membrane penetrable sugar is trehalose, the membrane impenetrable sugar is dextran, and the moisture content is about 50%.