Ultra-high Yield Intravenous Immune Globulin Preparation

Abstract

An efficacious large-scale alcohol-free plasma fractionation production process which produces a high-yielding, non-denatured, double viral-inactivated intravenous human immune gamma globulin (IgG) product. The process employs one or more salts from a group of salts comprising sodium citrate, sodium acetate, sodium gluconate, ammonium sulfate, sodium chloride, sodium sulfate and ammonium chloride in two initial fractionation steps, followed by diafiltration to remove those salts employed. A process which employs alcohol via the process of the disclosed inventive method is also disclosed.

1 . A method of deriving a blood product from a blood based material comprising the steps of:
 (a) acquiring a predetermined quantity of the blood-based material for processing;   (b) preparing the quantity of blood-based material for processing;   (c) selecting ethanol as a first fractionation compound;   (d) adding the first fractionation compound to the quantity of blood-based material to yield a first separable product and a first residual product, wherein the first separable product is euglobulin-depleted;   (e) separating the first separable product from the first residual product to complete the first fractionation step;   (f) selecting ethanol as a second fractionation compound;   (g) adding a second fractionation compound to the first separable product to yield a second separable product and a second residual product, wherein the second separable product has a concentration of the second fractionation compound that is greater than a concentration of the first fractionation compound in the first separable product; (h) separating the second separable product from the second residual product to complete the second fractionation step;   (i) preparing the second separable product for diafiltration; and   (j) diafiltering the second separable product to form a lower volume third product substantially free of the first and second fractionation compounds.   
     
     
         2 . The process for blood-based material fractionation according to  claim 1  wherein step (d) comprises adding a quantity of the first fractionation compound to produce a concentration of 12% wt/wt. 
     
     
         3 . The process for blood-based material fractionation according to  claim 1  wherein step (d) comprises adding a quantity of the first fractionation compound to produce a concentration within a range of 11-13% wt/wt. 
     
     
         4 . The process for blood-based material fractionation according to  claim 1  wherein step (c) comprises selecting at least one salt from a group of salts comprising sodium citrate, sodium acetate, sodium gluconate, ammonium sulfate, sodium chloride, sodium sulfate and ammonium chloride to be used in place of ethanol as the first fractionation compound. 
     
     
         5 . The process for blood-based material fractionation according to  claim 1  wherein step (g) comprises adding a quantity of the second fractionation compound to produce a concentration of 22% wt/wt. 
     
     
         6 . The process for blood-based material fractionation according to  claim 1  wherein step (g) comprises adding a quantity of the second fractionation compound to produce a concentration within a range of 21-23% wt/wt. 
     
     
         7 . The process for blood-based material fractionation according to  claim 1  wherein step (f) comprises selecting at least one salt from a group of salts comprising sodium citrate, sodium acetate, sodium gluconate, ammonium sulfate, sodium chloride, sodium sulfate and ammonium chloride to be used in place of ethanol as the second fractionation compound.