Methods for making mixed allergen compositions

Abstract

Methods of making mixed allergen products are provided, wherein the mixed allergen products are substantially free of replication viable organisms.

1 . A method of making a mixed allergen product substantially free of replication viable organisms, comprising:
 providing bulk mixed allergen material comprising 2 to 20 individual complete food allergens; and   sterilizing the bulk mixed allergen material by dry heat sterilization, thereby obtaining the mixed allergen product.   
     
     
         2 . The method of  claim 1 , further comprising providing 2 to 20 individual complete food allergens, and blending the 2 to 20 individual complete food allergens together to obtain the bulk mixed allergen material,
 wherein:   the individual complete food allergens are selected from the group consisting of almond, cashew, cod, egg, hazelnut, milk, oat, peanut, pecan, pistachio, salmon, sesame, shrimp, soy, walnut, and wheat; and/or   blending further comprises blending the 2 to 20 individual complete food allergens with one or more than one bulking agent; and/or   after blending, the bulk mixed allergen material is discharged into lined drums.   
     
     
         3 - 6 . (canceled) 
     
     
         7 . The method of  claim 1 , wherein the dry heat sterilization is at a temperature of about 65° C. to about 175° C. for about 18 hours to about 72 hours,
 wherein: 
 the dry heat sterilization comprises using a sterilization system having a furnace and a heating chamber, wherein the furnace provides about 250,000 BTUs to about 750,000 BTUs of heat to the heating chamber; and/or 
 the bulk mixed allergen material is first packaged into thermoresistant packaging before sterilizing; and/or 
 temperature probes are placed with the bulk mixed allergen material during sterilizing to monitor the temperature of the dry heat sterilization. 
 
     
     
         8 - 10 . (canceled) 
     
     
         11 . The method of  claim 1 , wherein the mixed allergen product has at least about a 1 log reduction to at least about a 4 log reduction in aerobic bacterial organism plate counts as compared to corresponding bulk mixed allergen material that has not been sterilized. 
     
     
         12 . The method of  claim 1 , wherein the mixed allergen product has:
 less than about 100,000 CFU/g of aerobic bacterial organisms, and/or   less than about 10 CFU/g of coliforms, and/or   less than about 10 CFU/g of  Escherichia coli , and/or   less than about 10 CFU/g of Enterobacteriaceae, and/or   less than about 10 CFU/g of  Salmonella , and/or   less than about 10 CFU/g of  Cronobacter , and/or   less than about 10 CFU/g of  Staphylococcus aureus , and/or   less than about 10 CFU/g of yeast, and/or   less than about 10 CFU/g of mold.   
     
     
         13 - 17 . (canceled) 
     
     
         18 . The method of  claim 1 , wherein the mixed allergen product is negative in a PCR-based assay for  Listeria  species or  Cronobacter  species per 25 grams of the mixed allergen product. 
     
     
         19 . (canceled) 
     
     
         20 . The method of  claim 1 , wherein the mixed allergen product is negative in a PCR-based assay for  Salmonella  species per 375 g of the mixed allergen product. 
     
     
         21 . (canceled) 
     
     
         22 . (canceled) 
     
     
         23 . The method of  claim 1 , wherein the mixed allergen product has a fat content of about 10% to about 20% by weight. 
     
     
         24 . The method of  claim 1 , wherein protein integrity of the mixed allergen product is substantially similar to protein integrity of corresponding bulk mixed allergen material that has not been sterilized. 
     
     
         25 . The method of  claim 24 , wherein the protein integrity of the mixed allergen product is determined by SDS-PAGE. 
     
     
         26 . The method of  claim 1 , wherein the mixed allergen product has a protein content of about 40% to about 50% by weight. 
     
     
         27 . The method of  claim 1 , wherein the mixed allergen product has about 1% to about 10% moisture by weight. 
     
     
         28 . The method of  claim 1 , wherein the mixed allergen product has a water activity of about 0.1 to about 0.6. 
     
     
         29 . The method of  claim 1 , wherein less than about 10% by weight of the mixed allergen product are particles having a diameter greater than 500 μm. 
     
     
         30 . The method of  claim 1 , wherein the mixed allergen product is darker in color as compared to corresponding bulk mixed allergen material that has not been sterilized. 
     
     
         31 . The method of  claim 1 , wherein the mixed allergen product has a substantially similar taste profile as compared to corresponding bulk mixed allergen material that has not been sterilized. 
     
     
         32 . The method of  claim 1 , wherein sterilizing further comprises one or more than one further application of dry heat sterilization. 
     
     
         33 . A method of making a mixed allergen product substantially free of replication viable organisms, comprising:
 providing 2 to 20 individual complete food allergens;   sterilizing each of the 2 to 20 individual complete food allergens by dry heat sterilization, thereby obtaining 2 to 20 sterilized individual complete food allergens; and   blending the 2 to 20 sterilized individual complete food allergens together, thereby obtaining the mixed allergen product.   
     
     
         34 - 40 . (canceled) 
     
     
         41 . A mixed allergen product substantially free of replication viable organisms prepared by the method of  claim 1 .