| 摘要 |
Methods are disclosed for the sterilization of functioning biological materials, biochemical entities and biologically active molecules and for their preservation for storage at room temperature. Biological contaminants are significantly reduced in titer or eliminated while maintaining preservation of functional integrity of sterilized and stabilized products derived from the present methods. These materials may be mainly structural in function, such as bone, or may demonstrate active molecular function, as in the case of hemoglobin and antibodies. Treatments for stabilizing the sterilized biologics include alteration of material temperature, control of radiation dose rate, optimization of irradiation time, control of oxygen content, the use of stabilizers, specification of pH, inclusion of particular solvents, and alteration of the type of radiation applied. A sterilized and stabilized biological product so treated can be stored at room temperature, thereby making it much more available and easier to use versus, lyophilized, conventional frozen or cold stored biologics.
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