Human milk compositions and methods of making and using same

Abstract

The disclosure features human milk fortifier compositions, standardized human milk, and methods of making and using same. In one embodiment, a pasteurized human milk composition includes a human protein constituent of about 35-85 mg/mL; a human fat constituent of about 60-110 mg/mL; and a human carbohydrate constituent of about 60-140 mg/mL.

1 - 65 . (canceled) 
     
     
         66 . A method for obtaining a pasteurized human milk fortifier, the method comprising:
 (a) genetically screening pooled human milk for one or more viruses selected from the group consisting of HIV-1, HBV and HCV;   (b) filtering the pooled human milk;   (c) heat-treating the pooled human milk:   (d) separating the pooled human milk into cream and skim;   (e) adding a portion of the cream to skim such that the resulting composition comprises:
 (i) 35-85 mg/mL of protein 
 (ii) 60-110 mg/mL of fat 
 (iii) 60-140 mg/ml, of carbohydrate; and 
   (f) pasteurizing the resulting composition from (e) thereby obtaining a pasteurized human milk fortifier.   
     
     
         67 . The method of  claim 66 , wherein the heat-treating comprises treating the pooled human milk at about 63° C. or greater for about 30 min. 
     
     
         68 . The method of  claim 66 , further comprising ultrafiltration of the skim after step (d). 
     
     
         69 . The method of  claim 66 , wherein the genetic screening in step (a) comprises utilizing the polymerase chain reaction. 
     
     
         70 . The method of  claim 66 , wherein the pooled human milk is filtered through a 200 micron filter in step (b). 
     
     
         71 . The method of  claim 66 , further comprising running the cream through a separator following step (d). 
     
     
         72 . The method of  claim 68 , wherein ultrafiltration the skim comprises filtering permeate out of the skim. 
     
     
         73 . The method of  claim 68 , further comprising washing the ultrafilters to obtain post wash solution. 
     
     
         74 . The method of  claim 73 , further comprising combining the post wash solution to skim. 
     
     
         75 . The method of  claim 66 , further comprising carrying out mineral analysis of the composition obtained after step (e). 
     
     
         76 . The method of  claim 66 , further comprising adding to the resulting composition obtained after step (e) one or more minerals selected from the group consisting of calcium, chloride, copper, iron, magnesium, manganese, phosphorus, potassium, sodium, and zinc. 
     
     
         77 . The method of  claim 66 , further comprising carrying out biological testing of a portion of the pasteurized human milk fortifier after step (f). 
     
     
         78 . The method of  claim 66 , further comprising carrying out nutritional testing of a portion of the composition after step (f). 
     
     
         79 . The method of  claim 66  wherein adding a portion of the cream to skim in step (e) is done such that the resulting composition comprises:
 (i) 55-65 mg/mL of protein 
 (ii) 60-110 mg/mL of fat 
 (iii) 60-140 mg/mL of carbohydrate. 
 
     
     
         80 . A method for obtaining a pasteurized human milk fortifier, the method comprising:
 (a) genetically screening pooled human milk by polymerase chain reaction for one or more viruses selected from the group consisting of HIV-1, HBV and HCV;   (b) filtering the pooled human milk through a 200 micron screen;   (c) heat-treating the pooled human milk at about 63° C. or greater for about 30 minutes;   (d) separating the pooled human milk into cream and skim;   (e) ultrafiltering the skim obtained in step (d) to remove permeate   (f) adding a portion of the cream obtained in step (d) to the ultrafiltering skim obtained in step (e) such that the resulting composition comprises:
 (i) 55-85 mg/mL of protein 
 (ii) 60-110 mg/mL of fat 
 (iii) 60-140 mg/mL of carbohydrate; 
   (g) carrying out mineral analysis on the composition;   (h) adding one or more of the minerals to the composition wherein the one or more minerals are selected from the group consisting of: calcium, chloride, copper, iron, magnesium, manganese, phosphorus, potassium, sodium, and zinc; and   (i) pasteurizing the resulting composition from (h) thereby obtaining at pasteurizing human milk fortifier.