Blood plasma product

Patent metadata

Field	Value
Publication number	US-12533602-B2
Application number	US-202418604041-A
Country	US
Kind code	B2
Filing date	Mar 13, 2024
Priority date	Sep 15, 2022
Publication date	Jan 27, 2026
Grant date	Jan 27, 2026

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 method of rehydrating a spray dried plasma unit having a spray dried plasma from donor plasma from one or more donors, comprising:
combining an amount of Sterile Water For Injection (SWFI) with the spray dried plasma unit; wherein the spray dried plasma reconstitutes in a time period ranging between about 2 minutes and about 5 minutes, as measured from first touch by a user to completed reconstitution with no visible clumps, to thereby obtain a reconstituted previously spray dried plasma; wherein the reconstituted previously spray dried plasma has a pH ranging from about 6.7 to about 7.8; wherein the reconstituted previously spray dried plasma has an amount of von Willebrand Ristocetin Cofactor (VWF:RCo) ranging from about 10 to about 200 IU/dL, or an amount of von Willebrand Factor Antigen (VWF:Ag) ranging from about 50 to 200 IU/dL; and wherein the reconstituted previously spray dried plasma allows for clot formation; and wherein the mean size of the particulates, compared to the mean size of the particulates in the donor plasma, is reduced by at least 10% when measured with a cell analyzer using an electrical sensing zone method for particulates having a size ranging from about 2 microns to 60 microns.

2 . The method of claim 1 , wherein the spray dried plasma has a plasma characteristic selected from the group consisting of:
a) dried plasma particles having a size ranging from about 1 to about 7 μm; b) residual moisture in a range from about 0.5% to about 2.5%; c) 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 spray dried plasma before storage; and d) a combination thereof.

3 . The method of claim 2 , wherein the spray dried plasma, when stored is stable, wherein a level of one or more plasma proteins of the reconstituted previously spray dried plasma 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 method of claim 1 , wherein the reconstituted previously spray dried plasma 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.

5 . The method of claim 1 , wherein the reconstituted previously spray dried plasma has an amount of a C5a level ranges from about 0.1 to about 30 ng/mL.

6 . The method of claim 1 , wherein reconstituted previously spray dried plasma has an amount of a C5a level is within 20% of that in never frozen plasma.

7 . The method of claim 1 , wherein an amount of vWF is measured by a von Willebrand Factor Antigen assay and the amount of vWF is within a range from 1% to 20% of an amount of vWF in donor plasma.

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

9 . The method of claim 1 , further comprising transfusing the reconstituted previously spray dried plasma into a recipient, wherein the recipient is a mammal.

10 . The method of claim 1 , further comprising transfusing the reconstituted previously spray dried plasma into a recipient, wherein the recipient is human.

11 . The method of claim 1 , wherein the reconstituted previously spray dried plasma has a further plasma characteristic selected from the group consisting of:
a) a reduced number of cholesterol crystals, when viewed at 100× magnification, as compared to reconstituted freeze dried plasma; b) stability for transfusion, after storage for up to 8 hours; and c) a combination thereof.

12 . The method of claim 11 , wherein the reconstituted previously spray dried plasma is suitable for transfusion for up to about 8 hours, and 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.

13 . The method of claim 11 , further comprising transfusing the reconstituted previously spray dried plasma into a recipient, wherein the recipient is a mammal.

14 . The method of claim 11 , further comprising transfusing the reconstituted previously spray dried plasma into a recipient, wherein the recipient is human.

15 . The method of claim 1 , wherein the mean size of particulates of the reconstituted previously spray dried plasma is reduced by about 60%, 50%, 40%, 30%, 25%, 20%, 15%, or 10% as compared to the mean size of particulates in the donor plasma.

Assignees

• Velico Medical Inc

Inventors

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

Classifications

• B01J2/04

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

• B01D1/20

  Sprayers (in general B05B) · CPC title

• B01D1/0082

  Regulation; Control · CPC title

• A61K35/16 Primary

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

• A61K9/16

  Agglomerates; Granulates; Microbeadlets {; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction (A61K9/20 takes precedence if the final form is a tablet; microspheres with drug-free outer coating, microcapsules A61K9/50; mixture of different granules, microcapsules, (coated) microparticles A61K9/5084; nanoparticles A61K9/51)} · CPC title