Methods for 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 method of making an improved standardized human milk nutritional formulation comprising 24 kcal/ounce, the method comprising:
 (i) collecting milk from one or more qualified human milk donors, wherein said one or more qualified donors have been qualified by interview and by screening one or more biological samples from the one or more donors, wherein the one or more biological samples are screened for viral and bacterial pathogens, wherein samples that test positive for one or more of said viral and/or bacterial pathogens are discarded, and wherein the one or more biological samples are further screened for drugs of abuse;   (ii) pooling the milk collected from the one or more qualified donors to create a pool of qualified milk; and   (iii) processing the pool of qualified milk in order to make the improved standardized human milk nutritional formulation comprising concentrating the nutrients in the pooled qualified milk to comprise 24 kcal/ounce.   
     
     
         2 . The method of  claim 1 , wherein the improved standardized human milk nutritional formulation comprises human protein, fat, and carbohydrates. 
     
     
         3 . The method of  claim 1 , wherein the improved standardized human milk nutritional formulation comprises about 70-115 mg/mL human milk carbohydrates. 
     
     
         4 . The method of  claim 3 , wherein the human milk carbohydrates comprise lactose. 
     
     
         5 . The method of  claim 1  wherein, the improved standardized human milk nutritional formulation comprises about 35-85 mg/mL human milk fat. 
     
     
         6 . The method of  claim 1 , wherein the osmolality of the improved standardized human milk nutritional formulation is less than about 400 mOsm/Kg H 2 O. 
     
     
         7 . The method of  claim 6 , wherein the osmolality of the improved standardized human milk nutritional formulation is from about 310 mOsm/Kg H 2 O to about 380 mOsm/Kg H 2 O. 
     
     
         8 . The method of  claim 1 , wherein the improved standardized human milk nutritional formulation does not comprise xenogeneic components. 
     
     
         9 . The method of  claim 1 , wherein the improved standardized human milk nutritional formulation comprises added minerals. 
     
     
         10 . The method of  claim 9 , wherein the minerals are selected from the group consisting of calcium, phosphorus, magnesium, zinc, manganese, copper, sodium, potassium, chloride, and iron. 
     
     
         10 . The method of  claim 1 , wherein the processing comprises one or more steps to reduce the bioburden of the pool of qualified milk. 
     
     
         11 . The method of  claim 10 , wherein the one or more steps to reduce bioburden are selected from the group consisting of heat treatment, pasteurization, and filtration. 
     
     
         12 . The method of  claim 1 , wherein concentrating the nutrients comprises filtering the pool of qualified milk. 
     
     
         13 . The method of  claim 12 , wherein the filtering comprises ultrafiltering. 
     
     
         14 . The method of  claim 1 , wherein the pathogens are HIV1, HIV2, HTLV I, HTLV II, HBV, HCV, syphilis, and/or  B. cereus.    
     
     
         15 . The method of  claim 1 , wherein the one or more biological samples screened for viral and bacterial pathogens are selected from blood and milk. 
     
     
         16 . The method of  claim 1 , wherein the one or more biological samples screened for drugs of abuse are selected from blood and milk. 
     
     
         17 . The method of  claim 1 , wherein the milk collected is matched to a qualified donor by comparing molecular markers in the collected milk with molecular markers obtained from one or more biological samples collected from the qualified donor. 
     
     
         18 . The method of  claim 17 , wherein the one or more biological samples collected to match the qualified donor to the milk are selected from blood and milk. 
     
     
         19 . A method for promoting growth of a premature infant comprising administering an improved standardized human milk nutritional formulation made according to the method of  claim 1  to the premature infant.