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 .- 47 . (canceled) 
     
     
         48 . A method for making a human milk fortifier comprising:
 a) pooling human milk from qualified donors to obtain a pool of human milk from qualified donors, comprising at least about 75 liters;   b) screening the pool of human milk from qualified donors for viral contamination, wherein milk that tests positive is discarded;   c) processing the pool of human milk from qualified donors to obtain a human milk fortifier comprising a human protein constituent of 55-65 mg/mL, a human fat constituent of 85-95 mg/mL, and a human carbohydrate constituent of 70-120 mg/mL, and wherein processing comprises adding one or more minerals; and   d) treating the human milk fortifier obtained in (c) to reduce bioburden;   thereby obtaining a bioburden reduced, human milk-derived human milk fortifier.   
     
     
         49 . The method of  claim 48 , wherein processing comprises concentrating nutrients. 
     
     
         50 . The method of  claim 49 , wherein concentrating comprises filtering. 
     
     
         51 . The method of  claim 50 , wherein filtering comprises ultrafiltering. 
     
     
         52 . The method of  claim 48 , wherein processing comprises separating the pool of human milk into a skim portion and a fat portion. 
     
     
         53 . The method of  claim 52 , wherein processing further comprises: adding a part of the fat portion to the skim portion to obtain a fat adjusted skim portion; ultrafiltering the fat adjusted skim portion to obtain a permeate portion and a protein rich skim portion; and mixing a fraction of the fat portion with the protein rich skim portion. 
     
     
         54 . The method of  claim 48 , wherein the human milk fortifier does not comprise xenogeneic components. 
     
     
         55 . The method of  claim 48 , wherein the pooled human milk is screened for the presence of one or more of HIV, HBV, and HCV. 
     
     
         56 . The method of  claim 48 , wherein the pooled human milk is screened for one or more of  B. cereus,  cocaine, opiates, methamphetamines, benzodiazepine, amphetamines, and THC. 
     
     
         57 . The method of  claim 48 , wherein the qualified donor is requalified periodically. 
     
     
         58 . The method of  claim 48 , wherein treating to reduce bioburden comprises one or more of heat treatment, filtration, and pasteurization. 
     
     
         59 . The method of  claim 48 , wherein the one or more minerals comprise one or more of calcium, chloride, copper, iron, magnesium, manganese, phosphorus, potassium, and sodium. 
     
     
         60 . The method of  claim 48 , wherein the human milk fortifier comprises a caloric content of about 1.35 to about 1.55 kcal/mL. 
     
     
         61 . The method of  claim 48 , wherein a donor is qualified by screening a subject for drug use and/or chronic illness comprising testing a biological sample from the donor, wherein the subject is a qualified donor if the biological sample did not test positive for drug use and/or chronic illness. 
     
     
         62 . The method of  claim 61 , further comprising comparing a DNA marker profile from the qualified donor and a DNA marker profile from a sample of donated human milk, wherein, if the DNA marker profiles match, such match indicates that the donated human milk was expressed by the specific qualified donor, thereby obtaining identity matched donor milk from a qualified human milk donor. 
     
     
         63 . The method of  claim 61 , wherein the biological sample is blood or milk.