# US 2010/0167378 A1 · Preparation of virally inactivated biological fluids having high alpha-2-antiplasmin activity

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- Number: US 2010/0167378 A1
- Document ID: US20100167378A1
- Status: Published application
- Kind: A1
- Application number: 12/527,111
- Filed: 2008-02-14
- Published: 2010-07-01
- Earliest claimed: 2007-02-14
- Assignees: Research Foundation for Medical Devices
- Inventors: Thierry Burnouf; Magdy El-Ekiaby; Hadi Alphonse Goubran; Miryana Radosevich
- Web page: https://patentgrep.com/patent/US20100167378A1

## CPC

- A61L 2/18: Liquid substances
- A61K 35/16: Blood plasma; Blood serum (umbilical cord blood A61K35/51)
- A61K 38/57: from animals; from humans {(A61K38/553, A61K38/556 take precedence)}
- A61L 2103/05: Living organisms or biological materials
- 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)
- 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)

## Abstract

The invention relates to the use of polyoxyethylene (4-5) p-t-octyl phenol (t-Oct-C6H4—(OCH2CH2)x0H, x=˜5) or polyoxyethylene (20) sorbitan monooleate in solvent/detergent viral inactivation of biological fluids for the preparation of a virally inactivated biological fluid having a high alpha 2-antiplasmin content.

## Claims

### Claim at position 1

1-8. (canceled)

### Claim 9

Method of solvent/detergent virally inactivating a biological fluid comprising adding polyoxyethylene (4-5) p-t-octyl phenol (t-Oct-C6H4—(OCH2CH2)xOH, x=˜5) or polyoxyethylene (20) sorbitan monooleate to said biological fluid, wherein the virally inactivated biological fluid has an alpha-2-antiplasmin (α2-AP) activity of at least 85% of the initial alpha-2-antiplasmin activity.

### Claim 10 (depends on 9)

The method of claim 9, wherein the virally inactivated biological fluid has an alpha-2-antiplasmin content of at least 88% of the initial alpha-2-antiplasmin activity.

### Claim 11 (depends on 9)

The method according to claim 9, wherein the virally inactivated plasma has an alpha-1-antitrypsin (α1-AT) activity of at least 80% of the initial alpha-1-antitrypsin activity.

### Claim 12 (depends on 9)

The method according to claim 9, wherein the virally inactivated plasma has a plasma activator inhibitor-1 (PAI-1) activity of at least 80% of the initial alpha-1-antiplasmin activity.

### Claim 13 (depends on 9)

The method according to claim 9, wherein the polyoxyethylene (4-5) p-t-octyl phenol is employed at a concentration of 0.1 to 2.0% by weight with respect to the weight of the biological fluid.

### Claim 14 (depends on 9)

The method according to claim 9, wherein the polyoxyethylene (20) sorbitan monooleate is employed at a concentration of 0.1 to 2.0% by weight with respect to the weight of the biological fluid.

### Claim 15 (depends on 9)

The method according to claim 9, wherein the biological fluid is selected from the group consisting of mammalian blood, blood plasma, blood serum, plasma fractions, precipitates from blood fractions and supernatants from blood fractionation, platelet poor plasma, cryo-poor plasma (cryosupernatant), recombinant products, and transgenic products.

### Claim 16 (depends on 9)

The method according to claim 9, wherein the solvent is selected within the group consisting of tri-(n-butyl)phosphate (TnBP), tri-(t-butyl)phosphate, tri-(n-hexyl)phosphate, tri-(2-ethylhexyl)phosphate, tri-(n-decyl)phosphate, di-(n-butyl)phosphate, di-(t-butyl)phosphate, di-(n-hexyl)phosphate, di-(2-ethylhexyl)phosphate, di-(n-decyl)phosphate, ethyl di(n-butyl)phosphate and mixtures thereof.

### Claim 17 (depends on 10)

The method according to claim 10, wherein the virally inactivated plasma has an alpha-1-antitrypsin (α1-AT) activity of at least 80% of the initial alpha-1-antitrypsin activity.

### Claim 18 (depends on 10)

The method according to claim 10, wherein the virally inactivated plasma has a plasma activator inhibitor-1 (PAI-1) activity of at least 80% of the initial alpha-1-antiplasmin activity.

### Claim 19 (depends on 10)

The method according to claim 10, wherein the polyoxyethylene (4-5) p-t-octyl phenol is employed at a concentration of 0.1 to 2.0% by weight with respect to the weight of the biological fluid.

### Claim 20 (depends on 10)

The method according to claim 10, wherein the polyoxyethylene (20) sorbitan monooleate is employed at a concentration of 0.1 to 2.0% by weight with respect to the weight of the biological fluid.

### Claim 21 (depends on 10)

The method according to claim 10, wherein the biological fluid is selected from the group consisting of mammalian blood, blood plasma, blood serum, plasma fractions, precipitates from blood fractions and supernatants from blood fractionation, platelet poor plasma, cryo-poor plasma (cryosupernatant), recombinant products, and transgenic products.