Methods for Sterilizing Biological Materials

Abstract

Methods are disclosed for sterilizing biological products to reduce the level of active biological contaminants such as viruses, bacteria, yeasts, molds, mycoplasmas and parasites.

1 - 26 . (canceled) 
     
     
         27 . A method for reducing the level of active biological contaminants or pathogens in bone, comprising
 contacting the bone with a composition comprising DMSO, trehalose and mannitol; and   irradiating the bone-containing composition with gamma radiation,   
       wherein the total dose of gamma radiation is at least about 12 kGy. 
     
     
         28 . The method of  claim 27 , wherein the bone-containing composition is below ambient temperature during irradiation. 
     
     
         29 . The method of  claim 27 , wherein the bone-containing composition is at a temperature below its freezing point during irradiation. 
     
     
         30 . The method of  claim 27 , wherein the irradiation is applied at a rate of at least about 0.1 kGy/hour to at least about 30.0 kGy/hour. 
     
     
         31 . The method of  claim 27 , wherein the total dose of gamma irradiation is at least about 20 kGy. 
     
     
         32 . The method of  claim 27 , wherein the total dose of gamma irradiation is at least about 26 kGy. 
     
     
         33 . The method of  claim 27 , wherein the bone is demineralized bone matrix. 
     
     
         34 . The method of  claim 27 , further comprising adjusting or maintaining the pH of the bone prior to irradiation. 
     
     
         35 . The method of  claim 27 , further comprising reducing residual solvent content of the bone prior to irradiation. 
     
     
         36 . The method of  claim 35 , wherein the residual solvent is a non-aqueous solvent. 
     
     
         37 . The method of  claim 35 , wherein the residual solvent is an aqueous solvent. 
     
     
         38 . The method of  claim 35 , wherein the residual solvent content is reduced to less than about 2.0%. 
     
     
         39 . The method of  claim 27 , further comprising contacting the bone with at least one sensitizer prior to irradiation. 
     
     
         40 . The method of  claim 27 , wherein the active biological contaminants or pathogens are selected from the group consisting of viruses, bacteria, yeasts, molds, parasites, prions and combinations thereof. 
     
     
         41 . The method of  claim 27  wherein the bone is maintained in an inert atmosphere during irradiation. 
     
     
         42 . The method of  claim 27  wherein the bone is maintained under vacuum during irradiation.