Rapid cryobaric sterilization and vaccine preparation
AssigneeBBI BioSeq, Inc.
InventorsJames A. Laugharn, Jr., David W. Bradley, Robert A. Hess
Life of this patent
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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 −20° C. to about 95° C.). New methods based on this discovery can have applications in, for example, the preparation of vaccines, the sterilization of blood plasma or serum, the decontamination of military devices, and the disinfection of medical equipment. The new methods can also be incorporated into production processes or research procedures.
Claims33
A method for sterilizing a material comprising at least one desired protein, the method comprising:
- providing said material and, while maintaining the temperature of the material at 4° C. or lower, increasing the pressure to an elevated pressure sufficient to sterilize the material but insufficient to irreversibly denatured the desired protein, thereby providing a sterilized material.
A method for sterilizing a material comprising at least one desired protein, the method comprising:
- providing said material and, while maintaining the temperature of the material below 25° C., increasing the pressure to an elevated pressure sufficient to sterlize the material but insufficient to irreversibly denature the desired protein, wherein the elevated pressure is in the range of about 10,000 to about 30,000 psi, thereby providing a sterilized material.
A method for sterilizing a material comprising at least one desired protein, the method comprising:
- providing said material and, while maintaining the temperature of the material below 25° C., increasing the pressure to an elevated pressure sufficient to sterilize the material but insufficient to irreversibly denature to desired protein, and further comprising cooling the material to a subzero temperature after the pressure increasing step,
- thereby providing a sterilized material.
A method for sterilizing a material comprising at least one desired protein, the method comprising:
- providing said material and, while maintaining the temperature of the material below 25° C., increasing the pressure to an elevated pressure sufficient to sterilize the material but insufficient to irreversibly denature the desired protein, and further comprising cooling the material to a decreased temperature, wherein the decreased temperature is in the range from about −40° C. to about 4° C.
- thereby providing a sterilized material.
A method for sterilizing a material comprising at least one desired protein, the method comprising:
- providing said material and, while maintaining the temperature of the material below 25° C., increasing the pressure to an elevated pressure sufficient to sterilize the material but insufficient to irreversibly denature the desired protein;
- warming the material to the initial temperature, and then
- decreasing the pressure,
- thereby providing a sterilized material.
A method for sterilizing a material comprising at least one desired protein, the method comprising:
- providing said material and, while maintaining the temperature of the material below 25° C., increasing the pressure to an elevated pressure sufficient to sterilize the material but insufficient to irreversibly denature the desired protein;
- decreasing the pressure;
- and then
- warming the material to the initial temperature, thereby providing a sterilized material.
A method for sterilizing a material comprising at least one desired protein, the method comprising:
- providing said material at an initial pressure and temperature;
- cooling the material to decreased temperature below 25° C., then, while maintaining the temperature of the material at the decreased temperature,
- increasing the pressure to an elevated pressure sufficient to sterilize the material but insufficient to irreversibly denature the desired protein, and
- repeatedly cycling the pressure between the elevated pressure and the initial pressure,
- thereby providing a sterilized material.
A method for sterilizing a material, the method comprising:
- providing a material at an initial pressure and temperature;
- increasing the pressure to an elevated pressure insufficient to irreversibly denature proteins of interest;
- and
- decreasing the pressure to the initial pressure, thereby providing a sterilized material, wherein the material to be sterilized includes a phase-change catalyst.
A method for sterilizing a sample that includes at least one desired protein, the method comprising:
- providing the sample at an initial pressure;
- increasing the pressure to a pressure sufficient to inactivate pathogens;
- maintaining the elevated pressure for a period of less than about 5 seconds;
- and
- restoring the initial pressure to provide a sterilized sample and to avoid substantial aggregation of the desired protein.
Dependencies are inferred from the claim text.