Blood plasma product

Patent metadata

Field	Value
Publication number	US-11975274-B2
Application number	US-202217945125-A
Country	US
Kind code	B2
Filing date	Sep 15, 2022
Priority date	Sep 15, 2022
Publication date	May 7, 2024
Grant date	May 7, 2024

Abstract

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).

First claim

What is claimed is:

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.

Assignees

• Velico Medical Inc

Inventors

• Liu Qiyong Peter
• Snyder Herman E
• Erickson Kyle D
• Ordway Evan P
• Merritt William J
• Meehan Richard
• Andrews Robert R
• Strohl Clair
• Sohn Jihae
• Popovsky Mark A
• Buckley Lisa A

Classifications

• F26B21/50

  Ducting arrangements from the source of air or other gases to the materials or objects being dried · CPC title

• A61J1/00

  Containers specially adapted for medical or pharmaceutical purposes (capsules or the like for oral use A61J3/07; specially adapted for surgical or diagnostic appliances or instruments A61B50/30; containers for radioactive substances G21F5/00) · CPC title

• A61M2202/0415

  Plasma · CPC title

• B01J2/04

  in a gaseous medium {(if combined with suspending the material in a gas, e.g. fluidised beds B01J2/16)} · CPC title

• A61K35/16 Primary

  Blood plasma; Blood serum (umbilical cord blood A61K35/51) · CPC title