Blood plasma product

Patent metadata

Field	Value
Publication number	US-12201920-B2
Application number	US-202318097822-A
Country	US
Kind code	B2
Filing date	Jan 17, 2023
Priority date	Sep 15, 2022
Publication date	Jan 21, 2025
Grant date	Jan 21, 2025

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 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.

Assignees

• Velico Medical Inc

Inventors

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