Rapid sterilization and vaccine preparation

• US 20020182107A1
• Filed: 08/07/2001
• Published: 12/05/2002
• Est. Priority Date: 06/15/1998
• Status: Active Grant

• Current Assignee: Pressure BioSciences, Inc.
• Original Assignee: BBI Bioseq Incorporated
• Inventors: Bradley, David W., Laugharn, James A. Jr., Hess, Robert A.
• Granted Patent: US 6,696,019 B2
• Time in Patent Office: Days
• US Class Current: 422/39
• CPC Class Codes: A23L 3/0155 using sub- or super-atmospheric pressures, or pressure variations transmitted by a liquid or gas
• CPC Class Codes: A61L 2/0011 using physical methods
• CPC Class Codes: A61L 2/02 using physical phenomena

Abstract

The invention is based on the discovery that biological and non-biological materials can be sterilized, decontaminated, or disinfected by repeatedly cycling between relatively high and low pressures. Pressure cycling can be carried out at low, ambient, or elevated temperatures (e.g., from about −40° C. to about 95° C., or intermediate ranges). New methods based on this discovery can have applications in, for example, the preparation of vaccines, the sterilization of blood plasma or serum, plant, animal, and human tissue, sputum, urine, feces, water, and ascites, the decontamination of military devices, food and beverage production, and the disinfection of medical equipment. The new methods can also be incorporated into production processes or research procedures.

Claims

1. A method for sterilizing a material comprising at least one desired macromolecule, the method comprising:

providing said material at an initial pressure; and

increasing the pressure to an elevated pressure sufficient to sterilize the material but insufficient to irreversibly inactivate the biological activity of said desired macromolecule, thereby providing a sterilized material.

2. The method of claim 1, wherein the material is provided at an initial pressure of about 1 atm.

3. The method of claim 1, wherein the material is provided at an initial temperature in the range of from about −

40°

C. to about 95°

C.

4. The method of claim 1, wherein the material is provided at an initial temperature of about −

40°

C. or lower.

5. The method of claim 1, wherein the material is provided at an initial temperature of about 95°

C. or higher.

6. The method of claim 1, wherein the elevated pressure is in the range of about 5,000 psi to about 120,000 psi.

7. The method of claim 1, wherein the desired biomolecule is selected from the group consisting of nucleic acids, proteins, lipids, carbohydrates, drugs, steroids, and nutrients.

8. The method of claim 1, further comprising decreasing the pressure to a decreased pressure, and cycling the pressure between the decreased pressure and the elevated pressure at least two times.

9. The method of claim 1, further comprising decreasing the pressure to a decreased pressure, and cycling the pressure between the decreased pressure and the elevated pressure at least ten times.

10. The method of claim 8, wherein the decreased pressure is half of the elevated pressure or less.

11. The method of claim 1, further comprising warming or cooling the material prior to the pressure-increasing step.

12. The method of claim 1, further comprising warming or cooling the material after the pressure-increasing step.

13. The method of claim 1, wherein the material being sterilized is selected from the group consisting of a biological sample;

blood plasma, serum, or other plant, animal, or human tissue;

feces;

urine;

sputum;

medical or military equipment;

a foodstuff;

a pharmaceutical preparation;

ascites; and

a vaccine.

14. The method of claim 1, wherein the material being sterilized is initially contaminated with at least one of a bacterium, a prion, a virus, a fungus, a protist, a nucleic acid, and a protein.

16. The method of claim 15, wherein the material is provided at an initial pressure of about 1 atm.

17. The method of claim 15, wherein the elevated pressure is in the range of about 5,000 psi to about 120,000 psi.

18. The method of claim 15, further comprising decreasing the pressure to a decreased pressure, and cycling the pressure between the decreased pressure and the elevated pressure at least two times.

19. The method of claim 15, further comprising decreasing the pressure to a decreased pressure, and cycling the pressure between the decreased pressure and the elevated pressure at least ten times.

20. The method of claim 18, wherein the decreased pressure is half of the elevated pressure or less.

21. The method of claim 15, further comprising warming or cooling the material prior to the pressure-increasing step.

22. The method of claim 15, further comprising warming or cooling the material after the pressure-increasing step.

23. The method of claim 15, wherein the material being sterilized is selected from the group consisting of a biological sample;

blood plasma, serum, or other plant, animal, or human tissue;

feces;

urine;

sputum;

medical or military equipment;

a foodstuff;

a pharmaceutical preparation;

ascites; and

a vaccine.

25. The method of claim 24, wherein the material is provided at an initial pressure of about 1 atm.

26. The method of claim 24, wherein the elevated pressure is in the range of about 5,000 psi to about 120,000 psi.

27. The method of claim 24, wherein the decreased pressure is half of the elevated pressure or less.

28. The method of claim 24, further comprising warming or cooling the material prior to the pressure-increasing step.

29. The method of claim 24, further comprising warming or cooling the material after the pressure-increasing step.

30. The method of claim 24, wherein the material being sterilized is selected from the group consisting of a biological sample;

blood plasma, serum, or other plant, animal, or human tissue;

feces;

urine;

sputum;

medical or military equipment;

a foodstuff;

a pharmaceutical preparation;

ascites; and

a vaccine.

31. The method of claim 24, wherein the material being sterilized is initially contaminated with at least one infectious agent selected from the group consisting of a bacterium, a prion, a virus, a fungus, a protist, an infectious nucleic acid, and an infectious protein.

15. A method for sterilizing a material initially contaminated with at least one infectious agent selected from the group consisting of a bacterium, a prion, a virus, an infectious nucleic acid, and an infectious protein, the method comprising:

providing said material at an initial temperature and pressure; and

increasing the pressure to an elevated pressure sufficient to sterilize the material, thereby providing a sterilized material,

wherein said initial temperature is lower than 60°

C.

24. A method for sterilizing a material, the method comprising:

providing said material at an initial temperature and pressure;

increasing the pressure to an elevated pressure sufficient to sterilize the material;

decreasing the pressure to a decreased pressure; and

repeating the increasing and decreasing steps at least once, thereby providing a sterilized material,

wherein the initial temperature is about 40°

C. or lower.