Rapid sterilization and vaccine preparation

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.

What is claimed is:  
     
         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.  
     
     
         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.    
     
     
         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.  
     
     
         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.    
     
     
         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.