Blood plasma product
The present invention relates to a spray dried plasma composition having one or more of the following characteristics: when reconstituted, largely amorphous and has no cholesterol crystals; when reconstituted, the number of large particulates is reduced; has low residual moisture; reconstitutes rapidly in under four minutes; highly stable when stored under refrigeration, at room temperature or at elevated temperatures and allows for storage for longer periods of time; when reconstituted, exhibits recovery of the most fragile of proteins, including von Willebrand's factor; when reconstituted with Sterile Water for Injection (SWFI), reconstituted plasma is at a pH that is near normal plasma pH, and does so without treatment or storage in CO 2 or other pH adjustment; and when reconstituted, has reduced complement activation (C5A, C3A).
1. A spray dried plasma made from donor plasma, said spray dried plasma comprising:
a) dried plasma particles having a size ranging from about 1 to about 7 μm;
b) when reconstituted, a reduced mean size of particulates when measured with a Coulter Multisizer 4 by the electrical sensing zone method for particulates having a size range from about 2 μm to 60 μm, as compared to the mean size of particulates in the donor plasma;
c) when reconstituted has a reduced number of cholesterol crystals, when viewed at 100× magnification, as compared to reconstituted freeze dried plasma;
d) residual moisture in a range from about 0.5% to about 2.5%;
e) stable when stored for a period of time ranging from about 1 day to about 48 months at a temperature ranging from about 1° C. to about 45° C., as compared to reconstituted spray dried plasma before storage;
f) when reconstituted, is stable for transfusion, after storage for up to 8 hours;
g) when reconstituted with Sterile Water For Injection (SWFI) has a pH ranging from about 6.7 to about 7.8; and
h) when reconstituted, has an amount of von Willebrand Ristocetin Cofactor (VWF:RCo) ranging from about 10 to about 200 IU/dL, or and amount of von Willebrand Factor Antigen (VWF:Ag) ranging from about 50 to 200 IU/dL
wherein, when the spray dried plasma is reconstituted to thereby obtain reconstituted spray dried plasma, the reconstituted spray dried plasma allows for clot formation.
2. The spray dried plasma of claim 1 , when reconstituted, the mean size of particulates is reduced by about 60%, 50%, 40%, 30%, 25%, 20%, 15%, 10% 5%, 4%, 3%, 2%, 1% as compared to the mean size of particulates in the donor plasma.
3. The spray dried plasma of claim 1 , wherein spray dried plasma, when stored is stable, wherein a level of one or more plasma proteins of the spray dried plasma when reconstituted is within about 20%, as compared to a level of the one or more plasma proteins in reconstituted spray dried plasma before storage.
4. The spray dried plasma of claim 1 , wherein when reconstituted, the reconstituted spray dried plasma is suitable for transfusion for up to about 8 hours, wherein a level of one or more plasma proteins of the reconstituted spray dried plasma is within about 20%, as compared to a level of the one or more plasma proteins in reconstituted spray dried plasma contemporaneously after being spray dried.
5. The spray dried plasma of claim 1 , wherein when reconstituted with SWFI per has a pH of about 6.7, 6.8, 6.9, 7.0, 7.1, 7.2, 7.3, 7.4, 7.5, 7.6, 7.7, or 7.81f.
6. The spray dried plasma of claim 1 , wherein an amount of a C5a level ranges from about 0.1 to about 30 ng/mL.
7. The spray dried plasma of claim 1 , wherein an amount of a C5a level is within 20% of that in never frozen plasma.
8. The spray dried plasma of claim 1 , wherein the amount of vWF is measured by von Willebrand Factor Ristocetin Cofactor and the amount of vWF within about 20% of an amount of vWF in donor plasma.
9. The spray dried plasma of claim 1 , wherein the amount of vWF is measured by von Willebrand Factor Ristocetin Cofactor and the amount of vWF within about 10% of an amount of vWF in donor plasma.
10. The spray dried plasma of claim 1 , wherein the amount of vWF is measured by von Willebrand Factor Antigen and the amount of vWF within about 20% of an amount of vWF in donor plasma.
11. The spray dried plasma of claim 1 , wherein the amount of vWF is measured by von Willebrand Factor Antigen and the amount of vWF within about 10% of an amount of vWF in donor plasma.
12. The spray dried plasma of claim 1 , wherein the residual moisture is about 2.5%, 2.0%, 1.5%, 1.0% or 0.5%.
13. The spray dried plasma of claim 1 , wherein the recipient is a mammal.
14. The spray dried plasma of claim 1 , wherein the recipient is human.
15. A reconstituted previously spray dried plasma, wherein the previously spray dried plasma is dried from donor plasma, wherein said reconstituted previously spray dried plasma has a mean size of particulates, when measured with a Coulter Multisizer 4 by the electrical sensing zone method, ranging from about 2 μm to 60 μm, and wherein that size range is reduced, as compared to the mean size of particulates in the donor plasma.
16. The reconstituted previously spray dried plasma of claim 15 , wherein the mean size of particulates is reduced by about 60%, 50%, 40%, 30%, 25%, 20%, 15%, 10% 5%, 4%, 3%, 2%, 1%, as compared to the mean size of particulates in donor plasma.