PROTECTION OF BIOLOGICALLY ACTIVE MOLECULES DURING RADIATION STERILIZATION

Compositions and methods are disclosed that relate to protecting biological activity of a biologically active molecule, including a biologically active protein or biological response modifier such asan immune response modifier, against radiation damage during radiation sterilization. Inclusion of at least one radioprotectant compound, for example, cysteine, reduced glutathione, melatonin, and/orhistidine, in an exemplary mitogenic lectin formulation during spray-drying onto surfaces of immunoassay tubes, surprisingly protected the lectin against loss of biological (mitogenic) activity that would otherwise result from electron beam radiation sterilization. The radioprotectant compound also protected other biologically active molecules and stabilized their biological activities, permittingthem to retain biological activity after extended storage following the radiation treatment. 本发明公开了涉及保护生物活性分子的生物活性免于辐射灭菌期间的辐射损害的组合物和方法，所述生物活性分子包括生物活性蛋白或生物反应调节剂，例如免疫反应调节剂。在喷雾干燥到免疫测定管的表面上的过程中，在示例性促有丝分裂凝集素制剂中包含至少一种辐射防护剂化合物(例如，半胱氨