# US 2019/0167792 A1 · Anaerobic Blood Storage and Pathogen Inactivation Method

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- Number: US 2019/0167792 A1
- Document ID: US20190167792A1
- Status: Published application
- Kind: A1
- Application number: 16/304,611
- Filed: 2017-05-25
- Published: 2019-06-06
- Earliest claimed: 2016-05-27
- Assignees: Hemanext Inc.
- Applicants: New Health Sciences, Inc.
- Inventors: Samuel O. Sowemimo-Coker; Jeffrey Sutton; Tatsuro Yoshida
- Web page: https://patentgrep.com/patent/US20190167792A1

## CPC

- A61K 41/17: by ultraviolet [UV] or infrared [IR] light, X-rays or gamma rays
- A61K 35/18: Erythrocytes (haemoglobin A61K38/42)
- A61L 2/088: using photocatalysts or photosensitisers
- A61L 2/10: Ultraviolet [UV] radiation
- A61L 2/16: using chemical substances
- A61P 7/00: Drugs for disorders of the blood or the extracellular fluid
- A61L 2103/05: Living organisms or biological materials
- A61L 2103/09: Blood or products thereof
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

A method for reducing hemolysis and microparticle formation during storage of pathogen reduced blood. Oxygen reduced blood compositions comprising SAGM and riboflavin having reduced hemolysis. Oxygen reduced blood compositions comprising SAGM and riboflavin having reduced microparticles. Oxygen and pathogen reduced blood compositions comprising CPAD and riboflavin having reduced hemolysis. Oxygen and pathogen reduced blood compositions comprising SAGM and riboflavin having reduced microparticles.

## Claims

### Claim 1

A method for blood pathogen reduction having reduced hemolysis comprising:
removing oxygen from a blood product to prepare an oxygen reduced blood product;
reducing blood pathogens from said blood product comprising:
adding riboflavin to a final concentration of between 40 to 60 μM and
irradiating said riboflavin containing blood product with UV light between 265-400 nm.

### Claim 2 (depends on 1)

The method of claim 1, further comprising storing said oxygen reduced pathogen reduced blood product under anaerobic conditions.

### Claim 3 (depends on 1)

The method of claim 1, further comprising reducing carbon dioxide from said blood product.

### Claim 4 (depends on 1)

The method of claim 1, wherein hemolysis is less than 0.2% at 14 days, less than 0.4% at 21 days, less than 0.5% at 28 days, less than 0.8% at 35 days, or less than 1.2% at 42 days.

### Claim at position 5

-7. (canceled)

### Claim 8 (depends on 1)

The method of claim 1, wherein said oxygen reduced pathogen reduced blood product is whole blood, leukoreduced whole blood, or packed red blood cells.

### Claim 9 (depends on 1)

The method of claim 1, wherein said blood product further comprises reduced microparticle formation compared to an oxygenated blood product.

### Claim 10

(canceled)

### Claim 11

(canceled)

### Claim 12

(canceled)

### Claim 13 (depends on 9)

The method of claim 9, wherein the number of microparticles is reduced by at least two fold at 14 days, reduced by at least 2 fold at 21 days, or reduced by at least 2 fold at 42 days relative to a sample treated in the presence of oxygen.

### Claim at position 12

-18. (canceled)

### Claim 19

Oxygen reduced whole blood comprising whole blood collected in CPD, having between 40 to 60 μM riboflavin, having an oxygen saturation (SO2) of less than 25%, and having a pCO2 of 90 mmHg or less at 37° C., wherein said oxygen reduced whole blood has been irradiated with UV light between 265 to 400 nm.

### Claim 20

(canceled)

### Claim 21

(canceled)

### Claim 22

(canceled)

### Claim 23 (depends on 20)

The oxygen reduced whole blood of claim 20, wherein said pCO2 is 5 to 20 mmHg at 37° C.

### Claim 24

(canceled)

### Claim 25 (depends on 19)

The oxygen reduced whole blood of claim 19, wherein said irradiation comprises a UV dosage of between 3.2 to 7.0 J/cm2.

### Claim 26

A method for blood pathogen reduction having reduced hemolysis comprising:
removing oxygen from a blood product to prepare an oxygen reduced blood product;
reducing blood pathogens from said oxygen reduced blood product comprising:
adding S-303 to a final concentration of 0.2 mM; and
adding glutathione (GSH) to a final concentration of between 2 to 20 mM.

### Claim 27 (depends on 26)

The method of claim 26, further comprising storing said oxygen reduced pathogen reduced blood product under anaerobic conditions.

### Claim 28 (depends on 26)

The method of claim 26, further comprising reducing carbon dioxide from said blood product.

### Claim 29

(canceled)

### Claim 30

(canceled)

### Claim 31 (depends on 26)

The method of claim 26, further comprising mixing in an additive solution having an acidic pH after centrifuging.

### Claim 32 (depends on 26)

The method of claim 26, wherein said blood product further comprises reduced microparticle formation compared to an oxygenated blood product.

### Claim at position 27

-37. (canceled)

### Claim 38

Oxygen reduced red blood cells having a final concentration of approximately 0.2 mM S-303, having an oxygen saturation (SO2) of less than 25%, and having a pCO2 of 90 mmHg or less at 37° C.

### Claim 39 (depends on 38)

The oxygen reduced red blood cells of claim 38, further comprising a final concentration of between approximately 2 to 20 mM glutathione (GSH).

### Claim at position 30

-44. (canceled)

### Claim 45 (depends on 38)

The method of claim 38, wherein said oxygen reduced red blood cells comprise reduced microparticle formation of greater than four-fold after at least one week of storage compared to pathogen inactivated oxygenated blood.

### Claim 46

A method for improving the efficacy of pathogen inactivation of S-303 in red blood cells comprising:
removing oxygen from red blood cells to prepare an oxygen reduced blood product;
adding S-303 to a final concentration of 0.2 mM; and
adding glutathione (GSH) to a final concentration of between 2 to 20 mM.

### Claim 47 (depends on 46)

The method of claim 46, further comprising reducing carbon dioxide from said blood product.
