Methods for sterilizing preparations of glycosidases

Abstract

Methods are disclosed for sterilizing preparations of glycosidases to reduce the level therein of one or more active biological contaminants or pathogens, such as viruses, bacteria (including inter- and intracellular bacteria, such as mycoplasmas, ureaplasmas, nanobacteria, chlamydia, rickettsias), yeasts, molds, fungi, single or multicellular parasites, prions or similar agents responsible, alone or in combination, for TSEs. These methods involve sterilizing preparations of glycosidases, such as alpha-glucosidase or alpha-galactosidase, with irradiation.

1 . (cancelled)  
     
     
         2 . A method for sterilizing a preparation of one or more glycosidases that is sensitive to radiation, said method comprising: 
 (i) adding to said preparation of one or more glycosidases at least one stabilizer in an amount effective to protect said preparation of one or more glycosidases from said radiation; and    (ii) irradiating said preparation of one or more glycosidases with a suitable radiation at an effective rate for a time effective to sterilize said preparation of one or more glycosidases.    
     
     
         3 . A method for sterilizing a preparation of one or more glycosidases that is sensitive to radiation, said method comprising: 
 (i) reducing the residual solvent content of said preparation of one or more glycosidases to a level effective to protect said preparation of one or more glycosidases from said radiation; and    (ii) irradiating said preparation of one or more glycosidases with a suitable radiation at an effective rate for a time effective to sterilize said preparation of one or more glycosidases.    
     
     
         4 . A method for sterilizing a preparation of one or more glycosidases that is sensitive to radiation, said method comprising: 
 (i) reducing the temperature of said preparation of one or more glycosidases to level effective to protect said preparation of one or more glycosidases from said radiation; and    (ii) irradiating said preparation of one or more glycosidases with a suitable radiation at an effective rate for a time effective to sterilize said preparation of one or more glycosidases.    
     
     
         5  to  85  (cancelled)