IP Library Granted Patent US 10,357,516
Granted Patent B2
US 10,357,516 · App. 15/628,510 · Granted Jul 23, 2019

Pathogen-inactivated red blood cell compositions

Inventors: Naheed Mufti (San Ramon, CA); Anna Erickson (Richmond, CA); Anne North (Pleasant Hill, CA)
Assignee: Cerus Corporation
A61K35/18A01N1/02A01N1/0215A01N1/0226A01N43/42A01N2300/00A61K35/00A61L2/0082
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Quick Facts
Patent No.
US 10,357,516
App. No.
15/628,510
Granted
Jul 23, 2019
Kind
B2
Abstract

The present invention provides pathogen-inactivated red blood cell compositions.

Claims (25)

1. A composition comprising: (i) red blood cells, (ii) a quencher at a concentration of less than about 10 mM, and (iii) a final additive solution, wherein the composition is produced by a method of reducing dehydration of the red blood cells, wherein the method of reducing dehydration of the red blood cells comprises:

(I) providing a mixture comprising: (a) the quencher, wherein the quencher is capable of reacting with a pathogen-inactivating compound, (b) about 0.5 to 1.5 equivalents of base, wherein an equivalent means a molar amount that is equivalent to the molar amount of quencher in the mixture, (c) the red blood cells, and (d) a treatment solution or diluent solution; wherein the treatment solution or diluent solution comprises one or more of dextrose, adenine, mannitol, citrate, and citric acid; and wherein the mixture comprises between about 40 mM and 100 mM chloride ion; and

(II) replacing the solution in the mixture of step (I) with the final additive solution, such that the concentration of the quencher in the mixture is decreased to less than about 10 mM;

wherein the level of dehydration of the red blood cells is decreased relative to the level of dehydration of red blood cells in a composition comprising a mixture of (a), (c), (d), and 2.0 or greater equivalents of base and in which the solution in the mixture comprising (a), (c), (d), and 2.0 or greater equivalents of base has not been replaced with a final additive solution.

2. The composition of claim 1 , wherein the quencher comprises cysteine or a derivative of cysteine.

3. The composition of claim 1 , wherein the quencher is glutathione or a pharmaceutically acceptable salt thereof.

4. The composition of claim 1 , wherein the quencher is glutathione monosodium salt.

5. The composition of claim 1 , wherein the concentration of the quencher is less than about 8 mM.

6. The composition of claim 1 , wherein the concentration of the quencher is less than about 6 mM.

7. The composition of claim 1 , wherein the red blood cells of the composition have less than 1% hemolysis.

8. The composition of claim 7 , wherein the red blood cells of the composition have less than 1% hemolysis at a time of 42 days at 4° C.

9. The composition of claim 1 , wherein the red blood cells of the composition have a Packed Cell Volume of greater than 50%.

10. The composition of claim 9 , wherein the red blood cells of the composition have a Packed Cell Volume of greater than 50% at a time of 42 days at 4° C.

11. The composition of claim 1 , wherein the red blood cells of the composition have a Median Corpuscular Fragility value greater than 140 after 42 days at 4° C.

12. The composition of claim 1 , wherein the red blood cells of the composition have a Median Corpuscular Fragility value greater than 150 after 28 days at 4° C.

13. The composition of claim 1 , wherein the treatment solution or diluent solution further comprises one or more of phosphate and chloride.

14. The composition of claim 1 , wherein the final additive solution comprises one or more of dextrose, sodium chloride, adenine, guanosine, glucose, citrate, citric acid, phosphate, and mannitol.

15. The composition of claim 1 , wherein the final additive solution is selected from the group consisting of AS-1, AS-3, SAG-M, Erythrosol, AS-5, PAGGS-M, and MAP.

16. The composition of claim 1 , wherein the base is NaOH.

17. The composition of claim 1 , wherein replacing the solution in the mixture with a final additive solution comprises centrifugation of the mixture followed by removal of the supernatant of the mixture.

18. The composition of claim 1 , wherein replacing the solution in the mixture of step (I) with the final additive solution comprises size-exclusion separation.

19. The composition of claim 1 , wherein replacing the solution in the mixture of step (I) with the final additive solution comprises use of expression devices.

20. The composition of claim 1 , wherein the red blood cells of the composition have an average anti-pathogen inactivating compound antibody binding capacity (ABC) of less than about 50,000.

21. The composition of claim 1 , wherein the red blood cells of the composition have an average anti-pathogen inactivating compound antibody binding capacity (ABC) of between about 25,000 and 70,000.

22. The composition of claim 1 , wherein the red blood cells of the composition have an average anti-pathogen inactivating compound antibody binding capacity (ABC) of between about 35,000 and 45,000.

Assignments (5)
RELEASE OF SECURITY INTEREST Recorded May 20, 2026
From: MIDCAP FUNDING IV TRUST
To: CERUS CORPORATION
Reel/Frame 075583/0598 →
RELEASE OF SECURITY INTEREST Recorded May 20, 2026
From: MIDCAP FINANCIAL TRUST
To: CERUS CORPORATION
Reel/Frame 075610/0621 →
AMENDED AND RESTATED INTELLECTUAL PROPERTY SECURITY AGREEMENT (REVOLVING LOAN) Recorded Aug 29, 2025
From: CERUS CORPORATION
To: MIDCAP FUNDING IV TRUST
Reel/Frame 072727/0854 →
AMENDED AND RESTATED INTELLECTUAL PROPERTY SECURITY AGREEMENT (TERM LOAN) Recorded Aug 29, 2025
From: CERUS CORPORATION
To: MIDCAP FINANCIAL TRUST
Reel/Frame 072727/0928 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 4, 2017
From: MUFTI, NAHEED; ERICKSON, ANNA; NORTH, ANNE
To: CERUS CORPORATION
Reel/Frame 043783/0486 →
Continuity (5)
Division 14530415 · Oct 31, 2014
Division 12936763
Provisional Application 61087034 · Aug 7, 2008
Provisional Application 61043666 · Apr 9, 2008
Related Publication 20180008639A1 · Jan 11, 2018
Cited By (6)
US 12,214,092 US 12,282,015 US 12,343,436 US 12,514,876 US 12,514,944 US 12,558,442