Method of blood pooling storage

Abstract

The disclosure provides methods of making a red blood cell, plasma, and platelet products having a uniform dose and volume. The method comprises pooling a plurality of blood units, leukoreducing the blood and inactivating any pathogen contained therein. Plasma, RBCs, and platelets are then divided into uniform dose and volume units which have an extended shelf life.

What is claimed is: 
     
       1. A method for preparing uniform dose blood component transfusion products, the method comprising the following steps in the recited order:
 a) leukoreducing 5-100 individual whole blood units from different donors of the same blood group and type to form leukoreduced blood components, wherein the leukoreduced blood components comprise red blood cells (RBCs), platelets, and plasma; 
 b) pooling the leukoreduced blood components from the 5-100 individual blood units to form a pooled leukoreduced blood component; 
 c) treating the pooled leukoreduced blood component to inactivate one or more pathogens; 
 d) separating a pooled RBC component, a pooled platelet component, and a pooled plasma component from the pooled leukoreduced blood component; 
 e) adding a storage solution to the pooled RBC component and dividing the pooled RBC component into uniform volume and dose RBC transfusion product units, wherein each uniform volume and dose RBC transfusion product unit contains a uniform number of RBCs or a uniform amount of hemoglobin; 
 f) adding a storage solution to the pooled platelet component and dividing the pooled platelet component into uniform volume and dose platelet transfusion products units, wherein each uniform volume and dose platelet transfusion product unit contains a uniform number of platelets; and 
 g) dividing the pooled plasma component into uniform volume and dose plasma transfusion product units. 
 
     
     
       2. The method of  claim 1 , wherein the storage solution comprises at least one material selected from the group consisting of adenine, glucose, phosphate, mannitol, guanosine, and a combination thereof. 
     
     
       3. The method of  claim 1 , wherein the treating step inactivates one or more pathogens without damaging the structure or function of the RBC or platelet components. 
     
     
       4. The method of  claim 1 , wherein the one or more pathogens are selected from the group consisting of viruses, bacteria, fungi, prions, parasites, and combinations thereof. 
     
     
       5. The method of  claim 1 , wherein the one or more pathogens are inactivated by at least one method selected from the group consisting of irradiation, solvent and detergent, magnetophoresis, immunomagnetic bead technology, filtration, and a combination thereof. 
     
     
       6. The method of  claim 1 , wherein each uniform volume and dose RBC transfusion product unit contains about 1×10 12  to about 5×10 12  RBCs. 
     
     
       7. The method of  claim 1 , wherein each uniform volume and dose RBC transfusion product unit contains about 20-80 g of hemoglobin. 
     
     
       8. The method of  claim 1 , wherein each uniform volume and dose platelet transfusion product unit contains about 2-6×10 11  platelets/unit. 
     
     
       9. The method of  claim 1 , further comprising the step of filtering out poorly-deformable RBCs from the RBC component or the blood component. 
     
     
       10. A method for preparing uniform dose blood component transfusion products from 5-100 whole blood units of the same blood group and type from different donors, the method comprising the following steps in the recited order:
 a) separating a cellular component and a plasma component from the 5-100 whole blood units, wherein the cellular component comprises RBCs, platelets, and white blood cells; 
 b) pooling the cellular components from the 5-100 whole blood units to form a pooled cellular component and pooling the plasma components from the 5-100 whole blood units to form a pooled plasma component; 
 c) treating the pooled plasma component with a solvent/detergent to inactivate pathogens and dividing the pooled plasma component into uniform volume and dose transfusion product units; 
 d) leukoreducing the pooled cellular component to form a pooled leukoreduced cellular component; 
 e) treating the pooled leukoreduced cellular component to inactivate one or more pathogens; 
 f) separating the pooled leukoreduced cellular component into a pooled RBC component and a pooled platelet component; 
 g) adding a storage solution to the pooled RBC component and dividing the pooled RBC component into uniform volume and uniform dose RBC transfusion product units, wherein each uniform volume and dose RBC transfusion product unit contains a uniform number of RBCs or a uniform amount of hemoglobin; and 
 h) adding a storage solution to the pooled platelet component and dividing the pooled platelet component into uniform volume and uniform dose platelet transfusion product units, wherein each uniform volume and dose platelet transfusion product unit contains a uniform number of platelet. 
 
     
     
       11. The method of  claim 10 , wherein the storage solution comprises at least one material selected from the group consisting of adenine, glucose, phosphate, mannitol, guanosine, and a combination thereof. 
     
     
       12. The method of  claim 10 , wherein the treating step inactivates one or more pathogens without damaging the structure or function of the RBC or platelet components. 
     
     
       13. The method of  claim 10 , wherein the one or more pathogens are selected from the group consisting of viruses, bacteria, fungi, prions, parasites, and combinations thereof. 
     
     
       14. The method of  claim 10 , wherein the one or more pathogens are inactivated by at least one method selected from the group consisting of irradiation, solvent and detergent, magnetophoresis, immunomagnetic bead technology, filtration and a combination thereof. 
     
     
       15. The method of  claim 10 , wherein each unit of the uniform volume and dose RBC transfusion product unit contains about 1×10 12  to about 5×10 12  RBCs. 
     
     
       16. The method of  claim 10 , wherein each unit of the uniform volume and dose RBC transfusion product unit contains about 20-80 g of hemoglobin. 
     
     
       17. The method of  claim 10 , wherein each unit of the uniform volume and dose platelet transfusion product unit contains about 2-6×10 11  platelets. 
     
     
       18. The method of  claim 10 , further comprising the step of filtering out poorly-deformable RBCs from the RBC component or the cellular component. 
     
     
       19. A method for preparing uniform dose blood component transfusion products, the method comprising the following steps in the recited order:
 a) leukoreducing 5-100 individual whole blood units from different donors of the same blood group and type to form leukoreduced blood components, wherein the leukoreduced blood components comprise RBCs, platelets, and plasma; 
 b) pooling the leukoreduced blood components from the 5-100 blood units to form a pooled leukoreduced blood component; 
 c) treating the pooled leukoreduced blood component to inactivate one or more pathogens; 
 d) separating at least one of an RBC component, a platelet component, and a plasma component from the pooled leukoreduced blood component; and 
 e) dividing the at least one of the RBC component, platelet component, and plasma component into uniform volume and dose transfusion product units, wherein each uniform volume and dose RBC transfusion product unit contains a uniform number of RBCs, each uniform volume and dose platelet transfusion product unit contains a uniform number of platelets, and each uniform volume and dose plasma transfusion product unit contains a uniform volume of plasma. 
 
     
     
       20. The method of  claim 19 , wherein the blood component is separated into at least two, or all three, of RBCs, platelets, and plasma from the pooled leukoreduced blood component. 
     
     
       21. A method for preparing uniform dose blood component transfusion products from 5-100 whole blood units of the same blood group and type from different donors, the method comprising the following steps in the recited order comprising:
 a) separating a cellular component and a plasma component from the 5-100 whole blood units, wherein the cellular component comprises RBCs, platelets, and white blood cells; 
 b) pooling the cellular component from the 5-100 whole blood units thereby forming a pooled cellular component, and pooling the plasma component from the 5-100 whole blood units thereby forming a pooled plasma component; 
 c) treating the pooled plasma component with a solvent/detergent to inactivate pathogens and dividing the pooled plasma into uniform volume and dose plasma transfusion product units; 
 d) leukoreducing the pooled cellular component; 
 e) treating the pooled leukoreduced cellular component to inactivate one or more pathogens; 
 e) separating the pooled leukoreduced cellular component into at least one of an RBC component and a platelet component; and 
 f) dividing at least one of the RBC components and the platelet components into uniform volume and dose RBC transfusion product units and uniform dose platelet transfusion product units, respectively, wherein each uniform volume and dose RBC transfusion product unit contains a uniform number of RBCs and each uniform volume and dose platelet transfusion product unit contains a uniform number of platelets.