Granted Patent B2

US 12,201,920 · App. 18/097,822 · Granted Jan 21, 2025

Inventors: Robert R. Andrews (Norfolk, MA); Herman E. Snyder (W. Lafayette, IN); William J. Merritt (Danvers, MA); Evan P. Ordway (Salem, MA); Clair Strohl (Emmaus, PA); Qiyong Peter Liu (Newton, MA); Jihae Sohn (Salem, MA); Lisa A. Buckley (Portland, OR); Mark A Popovsky (Sharon, MA)

Assignee: Velico Medical, Inc.

B01D1/18A61J1/00A61J3/00A61K9/16A61K35/16B01D1/0082B01D1/20B01J2/04

Abstract

Claims (27)

1. A dried plasma product dried from a donor plasma for transfusion into a recipient, wherein the donor plasma has a mean size of particulates, said dried plasma comprising:

when reconstituted, a reduced mean size of particulates, when measured with a cell analyzer using an electrical sensing zone method ranging from about 2 μm to 60 μm, as compared to the mean size of particulates in the donor plasma;

wherein when the dried plasma product is reconstituted to obtain a reconstituted previously dried plasma, the reconstituted previously dried plasma allows for clot formation.

2. The dried plasma product 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 dried plasma product of claim 2 , wherein the residual moisture is about 2.5%, 2.0%, 1.5%, 1.0% or 0.5%.

4. The dried plasma product from claim 1 , further comprising a plasma characteristic selected from the group consisting of:

a) dried plasma particles having a size ranging between from about 1 μm to about 7 μm;

b) when reconstituted has a reduced number of cholesterol crystals, when viewed at 100× magnification, as compared to reconstituted freeze dried plasma;

c) a residual moisture in a range from about 0.5% to about 2.5%;

d) 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 previously dried plasma before storage;

e) when reconstituted is stable for transfusion, after storage for up to about 8 hours;

f) when reconstituted with Sterile Water For Injection (SWFI) has a pH ranging from about 6.7 to about 7.8, and

g) when reconstituted, has an amount of von Willebrand Ristocetin Cofactor (VWF:RCo) ranging from about 10 to 200 IU/dL, or an amount of von Willebrand Factor Antigen (VWF:Ag) ranging from about 50 to 200 IU/dL; and

h) a combination thereof.

5. The dried plasma product of claim 1 , wherein dried plasma, when stored has stability, wherein a level of one or more plasma proteins of the reconstituted previously dried plasma is within about 20%, as compared to a level of the one or more plasma proteins in reconstituted previously dried plasma before storage.

6. The dried plasma product of claim 1 , wherein when reconstituted, the reconstituted previously dried plasma is suitable for transfusion for up to about 8 hours, wherein a level of one or more plasma proteins of the reconstituted previously dried plasma is within about 20%, as compared to a level of the one or more plasma proteins in reconstituted previously dried plasma contemporaneously after being dried.

7. The dried plasma product of claim 1 , wherein when reconstituted with SWFI 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 7.8.

8. The dried plasma product of claim 1 , wherein an amount of a C5a level ranges from about 0.1 to about 30 ng/mL.

9. The dried plasma product of claim 1 , wherein an amount of a C5a level is within 20% of that in never frozen plasma.

10. The dried plasma product of claim 9 , 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 the donor plasma.

11. The dried plasma product of claim 9 , 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 the donor plasma.

12. The dried plasma product of claim 1 , wherein the recipient is a mammal.

13. The dried plasma product of claim 1 , wherein the recipient is human.

14. The dried plasma product of claim 1 , wherein the dried plasma is spray dried plasma.

15. A reconstituted rehydrated, previously dried plasma product for transfusion into a recipient, wherein the previously dried plasma is dried from a donor plasma, wherein said reconstituted previously dried plasma has a reduced mean size of particulates when measured with a cell analyzer using an electrical sensing zone method ranging from about 2 μm to 60 μm, as compared to a mean size of particulates in the donor plasma, wherein the reconstituted previously dried plasma allows for clot formation.

16. The reconstituted previously dried plasma product of claim 15 , wherein the mean size of particulates in the reconstituted previously dried plasma 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 found in the donor plasma.

17. The rehydrated previously dried plasma product of claim 15 , wherein the dried plasma is spray dried plasma.

Assignments (4)

Continuity (2)

References Cited (400)