Rapid cryobaric sterilization and vaccine preparation

• US 6,696,019 B2
• Filed: 08/07/2001
• Issued: 02/24/2004
• Est. Priority Date: 06/15/1998
• Status: Expired due to Term

• Current Assignee: Pressure BioSciences, Inc.
• Original Assignee: BBI Bioseq Incorporated
• Inventors: Bradley, David W., Laugharn, James A. Jr., Hess, Robert A.
• Primary Examiner(s): MCKANE, ELIZABETH L
• Application Number:
  US09/924,266
• Publication Number:
  US 20020182107A1
• Time in Patent Office: 931 Days
• Field of Search: 422/39, 422/1, 435/236, 436/543
• 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 contaminated with a bacteria or virus comprising at least one desired protein, the method comprising:

providing said material at an initial pressure, and a temperature of 40°

C. or lower; and

while maintaining a temperature of 4°

C. or lower, performing the following steps;

increasing the pressure to an elevated pressure sufficient to sterilize the material but insufficient to irreversibly inactivate the biological activity of said desired protein;

decreasing the pressure to a decreased pressure; and

repeating the increasing and decreasing steps at least once, thereby providing a sterilized material, wherein the biological activity of the desired protein is maintained.

2. A method for sterilizing a material contaminated with a blood virus comprising at least one desired protein, the method comprising:

providing said material at an initial pressure, and a temperature of 4°

C. or lower; and

while maintaining a temperature of 4°

C. or lower, performing the following steps;

increasing the pressure to an elevated pressure sufficient to sterilize the material but insufficient to irreversibly inactivate the biological activity of said desired protein;

decreasing the pressure to a decreased pressure; and

repeating the increasing and decreasing steps at least once, thereby providing a sterilized material, wherein the biological activity of the desired protein is maintained.

3. A method for sterilizing a material contaminated with a bacteria or virus comprising at least one desired blood protein, the method comprising:

providing said material at an initial pressure, and a temperature of 4°

C. or lower; and

while maintaining a temperature of 4°

C. or lower, performing the following steps;

increasing the pressure to an elevated pressure sufficient to sterilize the material but insufficient to irreversibly inactivate the biological activity of said desired blood protein;

decreasing the pressure to a decreased pressure; and

repeating the increasing and decreasing steps at least once, thereby providing a sterilized material, wherein the biological activity of the desired protein is maintained.

4. A method for sterilizing a material contaminated with an enveloped virus comprising at least one desired protein, the method comprising:

providing said material at an initial pressure, and a temperature of 4°

C. or lower; and

while maintaining a temperature of 4°

C. or lower, performing the following steps;

increasing the pressure to an elevated pressure sufficient to sterilize the material but insufficient to irreversibly inactivate the biological activity of said desired protein;

decreasing the pressure to a decreased pressure; and

repeating the increasing and decreasing steps at least once, thereby providing a sterilized material, wherein the biological activity of the desired protein is maintained.

5. The method of claim 4, wherein the virus is HIV.

6. The method of claim 4, wherein the virus is HCV.

7. A method for sterilizing a material contaminated with a parovirus comprising at least one desired protein, the method comprising:

providing said material at an initial pressure, and a temperature of 4°

C. or lower; and

while maintaining a temperature of 4°

C. or lower, performing the following steps;

increasing the pressure to an elevated pressure sufficient to sterilize the material but insufficient to irreversibly inactivate the biological activity of said desired blood protein;

decreasing the pressure to a decreased pressure; and

repeating the increasing and decreasing steps at least once, thereby providing a sterilized material, wherein the biological activity of the desired protein is maintained.

8. A method for sterilizing a material contaminated with HAV virus comprising at least one desired protein, the method comprising:

providing said material at an initial pressure, and a temperature of 4°

C. or lower; and

while maintaining a temperature of 4°

C. or lower, performing the following steps;

increasing the pressure to an elevated pressure sufficient to sterilize the material but insufficient to irreversibly inactivate the biological activity of said desired blood protein;

decreasing the pressure to a decreased pressure; and

repeating the increasing and decreasing steps at least once, thereby providing a sterilized material, wherein the biological activity of the desired protein is maintained.

9. A method for sterilizing a material contaminated with a virus comprising at least one desired protein, the method comprising:

providing said material at an initial pressure, and a temperature of 4°

C. or lower; and

while maintaining a temperature of 4°

C. or lower, performing the following steps;

increasing the pressure to an elevated pressure sufficient to sterilize the material but insufficient to irreversibly inactivate the biological activity of said desired blood protein;

decreasing the pressure to a decreased pressure; and

repeating the increasing and decreasing steps at least once, thereby providing a sterilized material, wherein the biological activity of the desired protein is maintained.

10. The method of claim 9, wherein the virus is in blood.

11. The method of claim 9, wherein the protein is a blood protein.

12. A method for sterilizing a biological sample comprising a blood plasma, serum, plant tissue, animal tissue, human tissue, feces, urine ascites, or sputum, wherein the biological sample is contaminated with a bacteria or virus comprising at least one desired protein, the method comprising:

providing said biological sample at an initial pressure, and a temperature of 4°

C. or lower, performing the following steps;

increasing the pressure to an elevated pressure sufficient to sterilize the biological sample but insufficient to irreversibly inactivate the biological activity of said desired protein;

decreasing the pressure to a decreased pressure; and

repeating the increasing and decreasing steps at least once, thereby providing a sterilized biological sample, wherein the biological activity of the desired protein is maintained.

13. A method for sterilizing a pharmaceutical preparation or a vaccine, wherein the pharmaceutical preparation or vaccine is contaminated with a bacteria or virus comprising at least one desired protein, the method comprising:

providing said pharmaceutical preparation or vaccine at an initial pressure, and a temperature of 4°

C. or lower, performing the following steps;

increasing the pressure to an elevated pressure sufficient to sterilize the pharmaceutical preparation or vaccine but insufficient to irreversibly inactivate the biological activity of said desired protein;

decreasing the pressure to a decreased pressure; and

repeating the increasing and decreasing steps at least once, thereby providing a sterilized pharmaceutical preparation or vaccine, wherein the biological activity of the desired protein is maintained.