Methods of obtaining sterile milk and compositions thereof

Abstract

The disclosure provides a simple and effective methods for sterilization of milk without degradation or loss of biologically active agents in the milk and the products produced by such methods.

We claim: 
     
         1 . A human milk fortifier composition comprising human derived fat, protein, and carbohydrates, wherein the protein is present at a concentration of about 20-70 mg/mL and the carbohydrates are present at a concentration of about 70-115 mg/mL. 
     
     
         2 . The human milk fortifier composition of  claim 1 , wherein the fortifier increases the caloric content of human milk by about 4 Cal/ounce when mixed with human milk at a milk:fortifier ratio of about 80:20. 
     
     
         3 . The human milk fortifier composition of  claim 1 , wherein the fortifier composition does not comprise xenogeneic components. 
     
     
         4 . The human milk fortifier composition of  claim 1 , wherein the fortifier composition further comprises added minerals. 
     
     
         5 . The human milk fortifier composition of  claim 4 , wherein the minerals are selected from the group consisting of calcium, phosphorus, magnesium, zinc, manganese, copper, sodium, potassium, chloride, and iron. 
     
     
         6 . The human milk fortifier composition of  claim 1 , wherein the fortifier composition is prepared from donor milk from a qualified human breast milk donor. 
     
     
         7 . The human milk fortifier composition of  claim 6 , wherein the qualified human breast milk donor is qualified via screening for pathogens and drugs of abuse. 
     
     
         8 . The human milk fortifier composition of  claim 7 , wherein a biological sample of the qualified human breast milk donor is screened for the presence of at least one of HIV 1, HIV 2, HTLV I, HTLV II, HBV, HCV, syphilis, and  B. cereus.    
     
     
         9 . The human milk fortifier composition of  claim 8 , wherein the biological sample is selected from blood and milk. 
     
     
         10 . The human milk fortifier composition of  claim 6 , wherein the donor milk is tested for genetic markers to determine if the milk is from the qualified human breast milk donor. 
     
     
         11 . The human milk fortifier composition of  claim 1 , prepared by a method comprising pooling qualified donor milk and concentrating the nutrients in the pooled milk to obtain the human milk fortifier composition. 
     
     
         12 . The human milk fortifier composition of  claim 1 , prepared by a method comprising pooling qualified donor milk, screening the donor milk for the presence of pathogens, and filtering the pooled milk. 
     
     
         13 . The human milk fortifier composition of  claim 12 , wherein the filtering comprises ultrafiltration. 
     
     
         14 . The human milk fortifier composition of  claim 12 , wherein the method comprises one or more processing steps to reduce bioburden. 
     
     
         15 . The human milk fortifier composition of  claim 14 , wherein the one or more processing steps comprises pasteurization. 
     
     
         16 . The human milk fortifier composition of  claim 12 , wherein the method further comprises separating the pooled milk into a skim portion and a cream portion. 
     
     
         17 . The human milk fortifier composition of  claim 16 , wherein the method further comprises filtering the skim portion through one or more skim filters to obtain a permeate portion and a protein rich skim portion; and mixing a fraction of the cream portion with the protein rich skim portion. 
     
     
         18 . The human milk fortifier composition of  claim 17 , further comprising washing the one or more skim filters with permeate to obtain a protein wash, and adding the protein wash to the protein rich skim portion. 
     
     
         19 . The human milk fortifier composition of  claim 1 , wherein the composition comprises a caloric content of about 1.4 Cal/mL. 
     
     
         20 . A fortified human milk composition comprising a volume of human milk and the human milk fortifier composition of  claim 1 , wherein the milk and fortifier are present in the fortified human milk composition at a milk:fortifier ratio of about 80:20, and wherein the fortified human milk composition has a caloric content of about 4 Cal/ounce more than the caloric content of the volume of human milk. 
     
     
         21 . A method for providing supplemental nutrients to a preterm or low birth weight infant, comprising adding a human milk fortifier composition of  claim 1  to a volume of human milk to obtain a fortified human milk, and administering the fortified human milk to the premature or low birth weight infant. 
     
     
         22 . The method of  claim 21 , wherein the method promotes the growth of the preterm or low birth weight infant. 
     
     
         23 . The method of  claim 21 , wherein the method promotes immunological development of the preterm or low birth weight infant. 
     
     
         24 . The method of  claim 21 , wherein the method treats or prevents necrotizing enterocolitis (NEC) in the preterm or low birth weight infant. 
     
     
         25 . The method of  claim 21 , wherein the infant was born at less than 37 weeks gestational age. 
     
     
         26 . The method of  claim 21 , wherein the infant weighs less than 2500 grams at birth. 
     
     
         27 . The method of  claim 21 , wherein the infant weighs less than 1500 grams at birth. 
     
     
         28 . The method of  claim 21 , wherein the fortified human milk composition is administered to the infant as a bolus feeding or through a syringe infusion pump for continuous feeding. 
     
     
         29 . A kit comprising a human milk fortifier composition of  claim 1  and instructions for obtaining a fortified milk formulation comprising the human milk fortifier composition and a volume of human milk.