| 摘要 |
Methods are disclosed for the sterilization of functional biological materials, and for their preservation for shelf storage at uncontrolled temperatures. Biological contaminants are significantly reduced in titer or eliminated while maintaining preservation of functional integrity of sterilized and stabilized products. The sterilized and stabilized functional biological material can be stored at room temperature, thereby making it much more available and easier to use versus, lyophilized, conventional frozen or cold stored biologics. The present invention is further directed to inactivation of metalloenzymes, which are often degradative enzymes in biological systems. Reduction or elimination of the degradative function can be achieved by exposure to ionizing radiation, chemical agents or processes that inactivate the metalloenzymes. Inactivation of metalloenzymes enhances the stability of functional biological materials at ambient temperature.
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