Freeze-Dried Plasma Formats for the Trauma Care Field

Abstract

Disclosed are freeze-dried plasma formats specifically designed for the trauma care field. Blood plasma is subjected to a glucose removal step, a protein fraction up-concentration step and addition of stabilizers prior to freeze-drying. Preferable stabilizers are glutamine dipeptides, glutamine and glycine. The glutamine based formulation is added direct to plasma and serves three main purposes: 1) Increases stability of plasma proteins and stabilizes pH in freeze-dried state; 2) Increases stability of plasma proteins against Gamma Irradiation and thus allows for the application of a terminal sterilization step; 3) Introduces supplements beneficial to the trauma patient.

1 .- 30 . (canceled) 
     
     
         31 . A method of increasing coagulation faetor stability of plasma comprising:
 treating the plasma to reduce glucose concentration; and   freeze-drying the treated plasma.   
     
     
         32 . The method of  claim 31 , wherein treating comprises passing the plasma through a filtration system that removes glucose. 
     
     
         33 . The method of  claim 32 , wherein the filtration system is a hollow fiber filtration system. 
     
     
         34 . The method of  claim 31 , wherein plasma glucose concentration is reduced by at least about 75 percent. 
     
     
         35 . The method of  claim 31 , wherein treating comprises collecting said plasma with glucose-free anti-coagulants. 
     
     
         36 . The method of  claim 31 , further comprising supplementing the plasma with a stabilizer. 
     
     
         37 . The method of  claim 36 , wherein the stabilizer is a glutamine-containing dipeptide, 
     
     
         38 . The method of  claim 31 , further comprising sterilizing the freeze-dried and treated plasma with gamma irradiation and heat. 
     
     
         39 . The freeze-dried plasma made by the method of  claim 31 . 
     
     
         40 . The method of  claim 31 , further comprising reconstituting the freeze-dried plasma with an oxygen-free rehydration medium. 
     
     
         41 . A plasma made by the method of  claim 40 . 
     
     
         42 . The plasma of  claim 41 , which is supplemented with gas which is beneficial to a trauma patient or depleted of a gas that is harmful to said trauma patient. 
     
     
         43 . The method of  claim 40 , which provides for the control of gas content during reconstituting. 
     
     
         44 . A method of increasing coagulation factor stability of plasma comprising:
 treating the plasma to increase protein concentration; and   freeze-drying said treated plasma.   
     
     
         45 . The method of  claim 44 , wherein treating comprises passing the plasma through a filtration system that concentrates protein. 
     
     
         46 . The method of  claim 45 , wherein the filtration system concentrates particles of about 2 microns or higher and molecules of about 100 kD or higher. 
     
     
         47 . The method of  claim 44 , wherein the protein concentration is increased by at least about 65 percent. 
     
     
         48 . The method of  claim 44 , wherein treating comprises collecting said plasma with glucose free anticoagulants. 
     
     
         49 . The method of  claim 44 , further comprising supplementing the plasma with a stabilizer. 
     
     
         50 . The method of  claim 49 , wherein the stabilizer is a glutamine-containing dipeptide. 
     
     
         51 . The method of  claim 44 , further comprising sterilizing the freeze-dried and treated plasma with gamma irradiation and heat. 
     
     
         52 . The freeze-dried plasma made by the method of  claim 44 . 
     
     
         53 . The method of  claim 44 , further comprising reconstituting the freeze-dried plasma with an oxygen-free rehydration medium. 
     
     
         54 . A plasma made by the method of  claim 53 . 
     
     
         55 . The plasma of  claim 54 , which is supplemented with gas which is beneficial to a trauma patient or depleted of a gas that is harmful to said trauma patient. 
     
     
         56 . The method of  claim 53 , which provides for the control of gas content during reconstituting. 
     
     
         57 . A method of increasing coagulation factor stability of plasma comprising:
 treating the plasma to reduce glucose concentration and increase protein concentration; and   freeze-drying said treated plasma.   
     
     
         58 . The method of  claim 57 , wherein treating comprises passing the plasma through a filtration system that concentrates protein. 
     
     
         59 . The method of  claim 58 , wherein the filtration system concentrates particles of about 2 microns or higher and molecules of about 100 kD or higher. 
     
     
         60 . The method of  claim 57 , wherein the protein concentration is increased by at least about 65 percent and the plasma glucose concentration is reduced by at least about 75 percent. 
     
     
         61 . The method of  claim 57 , wherein treating comprises collecting said plasma with glucose free anticoagulants. 
     
     
         62 . The method of  claim 57 , further comprising supplementing the plasma with a stabilizer. 
     
     
         63 . The method of  claim 62 , wherein the stabilizer is a glutamine-containing dipeptide. 
     
     
         64 . The method of  claim 57 , further comprising sterilizing the freeze-dried and treated plasma with gamma irradiation and heat. 
     
     
         65 . The freeze-dried plasma made by the method of  claim 57 . 
     
     
         66 . The method of  claim 57 . further comprising reconstituting the freeze-dried plasma with an oxygen-free rehydration medium. 
     
     
         67 . A plasma made by the method of  claim 66 . 
     
     
         68 . The plasma of  claim 67 , which is supplemented with gas which is beneficial to a trauma patient or depleted of a gas that is harmful to said trauma patient. 
     
     
         69 . The method of  claim 66 , which provides for the control of gas content during reconstituting.