Method for Sterilization of Biological Preparations

• US 20080038818A1
• Filed: 06/07/2005
• Published: 02/14/2008
• Est. Priority Date: 06/07/2004
• Status: Active Grant

• Current Assignee: Core Dynamics Limited
• Original Assignee: Core Dynamics Limited
• Inventors: Kanias, Tamir, Natan, Yehudit
• Granted Patent: US 7,892,726 B2
• Time in Patent Office: Days
• US Class Current: 435/325
• CPC Class Codes: A61L 2/0035 Gamma radiation
• CPC Class Codes: A61L 2/0047 Ultraviolet radiation

Abstract

The invention provides a method for the sterilization of a biological preparation comprising desired viable biological entities. The method comprises irradiating a dried (e.g. freeze-dried) biological preparation with ionizing or UV radiation at an intensity and for a duration sufficient to reduce the amount or activity of living-matter contaminants in the biological preparation, the intensity and duration selected such that at least part of the desired biological entities in the sample remains viable. The method of the invention is particularly suitable for the reduction of the amount or activity of contaminants such as bacteria or viruses from biological preparations comprising red blood cells or platelets.

Claims

1. A method for the sterilization of a biological preparation comprising desired viable biological entities, the method comprising irradiating a dried biological preparation with ionizing or UV radiation at an intensity and for a duration sufficient to reduce the amount or activity of living-matter contaminants in the biological preparation, the intensity and duration selected such that at least part of the desired biological entities in the sample remains viable.

2. The method of claim 1, wherein the biological preparation comprises blood or portion thereof.

3. The method of any one of claims 1-2, wherein the desired biological entities are selected from red blood cells (RBC) or platelets.

4. The method of any one of claims 1-3, wherein the living-matter contaminants are selected from bacteria and viruses.

5. The method of any one of claims 1-4, wherein the amount or activity of living-matter contaminants is reduced to none.

6. The method of any one of claims 1-5, wherein the dry viable biological preparation is a freeze-dried biological preparation.

7. The method of any one of claims 1-6, wherein the radiation is UV radiation.

8. The method of any one of claims 1-6, wherein the UV radiation is irradiated for a period of 1 hour or less.

9. The method of any one of claims 1-6, wherein the ionizing radiation is gamma radiation.

10. The method of claim 9, wherein the gamma radiation is below 2.5 mega Rad.

11. The method of claim 10, wherein the gamma radiation is below 1 mega Rad.

12. The method of any one of claims 1-11, wherein the dried biological preparation has less than 60% less water than the original preparation.

13. The method of claim 12, wherein the dried biological preparation has less than 90% less water than the original preparation.

14. Viable biological preparation obtainable by the method of any one of the preceding claims.