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 for making an improved standardized human milk nutritional formulation 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 and wherein samples that test positive for one or more of said viral and/or bacterial pathogens are discarded, wherein the one or more biological samples are further screened for drugs of abuse, and 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;   (ii) pooling the milked collected from and matched to 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.   
     
     
         2 . The method of  claim 1 , wherein the standardized human milk nutritional formulation is a human milk fortifier. 
     
     
         3 . The method of  claim 2 , wherein the human milk fortifier comprises human protein, fat, and carbohydrates. 
     
     
         4 . The method of  claim 3 , wherein the human milk fortifier comprises about 20-70 mg/mL protein. 
     
     
         5 . The method of  claim 3 , wherein the human milk fortifier comprises about 70-115 mg/mL carbohydrates. 
     
     
         6 . The method of  claim 2 , wherein the human milk fortifier has a caloric content of about 1.35-1.55 Cal/mL. 
     
     
         7 . The method of  claim 2 , wherein the human milk fortifier comprises added minerals. 
     
     
         8 . The method of  claim 7 , wherein the minerals are selected from the group consisting of calcium, phosphorus, magnesium, zinc, manganese, copper, sodium, potassium, chloride, and iron. 
     
     
         9 . The method of  claim 1 , wherein the standardized human milk nutritional formulation has a caloric content of about 20 Cal/oz. 
     
     
         10 . The method of  claim 1 , wherein the standardized human milk nutritional formulation has a caloric content of about 24 Cal/oz. 
     
     
         11 . The method of  claim 1 , wherein the standardized human milk nutritional formulation does not comprise xenogeneic components. 
     
     
         12 . The method of  claim 1 , wherein the processing comprises one or more steps to reduce the bioburden of the pool of qualified milk. 
     
     
         13 . The method of  claim 12 , wherein the one or more steps to reduce bioburden are selected from the group consisting of heat treatment, pasteurization, and filtration. 
     
     
         14 . The method of  claim 1 , wherein the processing comprises concentrating the nutrients in the pool of qualified milk. 
     
     
         15 . The method of  claim 1 , wherein concentrating the nutrients comprises filtering the pooled of qualified milk. 
     
     
         16 . The method of  claim 15 , wherein the filtering comprises ultrafiltering. 
     
     
         17 . The method of  claim 1 , wherein the pathogens are selected from the group consisting of HIV1, HIV2, HTLV I, HTLV II, HBV, HCV, syphilis, and  B. cereus.    
     
     
         18 . The method of  claim 1 , wherein the one or more biological samples screened for viral and bacterial pathogens are selected from blood and milk. 
     
     
         19 . The method of  claim 1 , wherein the one or more biological samples screened for drugs of abuse are selected from blood and milk. 
     
     
         20 . The method of  claim 1 , wherein the one or more biological samples collected to match the qualified donor to the milk are selected from blood and milk. 
     
     
         21 . A standardized human milk nutritional formulation prepared by a method according to  claim 1 . 
     
     
         22 . The standardized human milk nutritional formulation of  claim 21 , wherein the formulation has a caloric content of about 20 Cal/oz. 
     
     
         23 . The standard human milk nutritional formulation of  claim 21 , wherein the formulation has a caloric content of about 24 Cal/oz. 
     
     
         24 . A human milk fortifier comprising about 20-70 mg/mL protein and about 70-115 mg/mL carbohydrates, wherein the fortifier is prepared by a method according to  claim 1 . 
     
     
         25 . A human milk fortifier comprising a caloric content of about 1.35-1.55 Cal/mL, wherein the fortifier is prepared by a method according to  claim 1 .