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 promoting growth of a premature infant, comprising administering a concentrated human milk nutritional formulation comprising 24 kcal/ounce to a premature infant,
 wherein the concentrated human milk nutritional formulation comprising 24 kcal/ounce is derived from pooled human milk from multiple qualified donors; comprises human milk protein, fat, and carbohydrates; and has reduced bioburden in comparison to raw human milk.   
     
     
         2 . The method of  claim 1 , wherein the concentrated human milk nutritional formulation comprises about 20-70 mg/mL human milk protein, about 70-115 mg/mL human milk carbohydrates, and comprises about 35-85 mg/mL human milk fat. 
     
     
         3 . The method of  claim 1 , wherein the osmolality of the concentrated human milk nutritional formulation is less than about 400 mOsm/Kg H 2 O. 
     
     
         4 . The method of  claim 3 , wherein the osmolality of the concentrated human milk nutritional formulation is from about 310 mOsm/Kg H 2 O to about 380 mOsm/Kg H 2 O. 
     
     
         5 . The method of  claim 1 , wherein the improved human milk nutritional formulation does not comprise xenogeneic components. 
     
     
         6 . The method of  claim 1 , wherein the concentrated human milk nutritional formulation comprises added minerals selected from the group consisting of calcium, phosphorus, magnesium, zinc, manganese, copper, sodium, potassium, chloride, and iron. 
     
     
         7 . The method of  claim 1 , wherein the concentrated human milk nutritional formulation is an ultrafiltered formulation. 
     
     
         8 . A method for making an improved concentrated human milk nutritional formulation comprising:
 (i) collecting milk from qualified human milk donors, wherein each of the qualified donors has been qualified by interview and by screening one or more biological samples from each of the donors, wherein the one or more biological samples are screened for viral and bacterial pathogens, wherein the one or more biological samples screened for viral and bacterial pathogens comprises a blood sample, wherein the donors are qualified if (a) the interview indicates the donors are not chronically ill and (b) the one or more samples are negative for viral and bacterial pathogens, wherein the milk collected from the qualified donors is screened for drugs of abuse, wherein milk that tests positive for drugs of abuse is discarded, 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 milk collected from and matched to the qualified donors to create a pool of qualified milk; and   (iii) processing the pool of qualified milk in order to make the improved concentrated human milk nutritional formulation, wherein the processing comprises concentrating one or more nutrients in the pool of qualified milk and one or more steps to reduce the bioburden of the pool of qualified milk;   thereby making a concentrated human milk formulation comprising human protein, fat, and carbohydrates.   
     
     
         9 . The method of  claim 8 , wherein the improved concentrated human milk nutritional formulation comprises about 24 kcal/ounce. 
     
     
         10 . The method of  claim 8 , wherein the improved concentrated human milk nutritional formulation comprises about 20 kcal/ounce. 
     
     
         11 . A human milk fortifier composition comprising human milk derived fat, protein, and carbohydrates, wherein the fat is present at a concentration of about 85-95 mg/mL, 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; and wherein the human milk fortifier composition is produced from human milk pooled from multiple qualified donors and has reduced bioburden in comparison to raw human milk. 
     
     
         12 . A method of administering a fortified human milk formulation to a subject, wherein the fortified human milk formulation comprises human milk mixed with a human milk fortifier composition, wherein the human milk fortifier composition comprises about 85-95 mg/mL human milk fat, about 20-70 mg/mL human milk protein, and about 70-115 mg/mL human milk carbohydrates, and wherein the human milk fortifier composition is produced from human milk pooled from multiple qualified donors and has reduced bioburden in comparison to raw human milk. 
     
     
         13 . A concentrated 24 kcal/ounce human milk composition comprising:
 about 20 to about 70 mg/mL of human milk protein,   about 38 to about 85 mg/mL of human milk fat, and   about 70 to about 115 mg/mL of human milk carbohydrates;   wherein the concentrated 24 kcal/ounce human milk composition is produced from a pool of human milk obtained from multiple qualified donors;   wherein the concentrated 24 kcal/ounce human milk composition comprises biological factors of the pool of human milk, wherein the biological factors comprise bioactive proteins, lipids, and carbohydrates; and   wherein the concentrated 24 kcal/ounce human milk composition has reduced bioburden in comparison to raw milk.   
     
     
         14 . A concentrated 20 kcal/ounce human milk composition derived from pooled human milk from multiple qualified donors, wherein the concentrated 20 kcal/ounce human milk composition comprises human milk protein, fat, and carbohydrates and has reduced bioburden in comparison to raw human milk. 
     
     
         15 . An ultrafiltered human milk nutritional formulation comprising about 24 kcal/ounce, about 20-70 mg/mL human milk protein, about 38-85 mg/mL human milk fat, and about 70-115 mg/mL human milk carbohydrates, wherein the ultrafiltered human milk nutritional formulation does not comprise xenogeneic components. 
     
     
         16 . An ultrafiltered human milk fortifier comprising about 1.35-1.55 kcal/mL, about 20-70 mg/mL human milk protein, about 85-95 mg/mL human milk fat, and about 70-115 mg/mL human milk carbohydrates, wherein the ultrafiltered human milk fortifier does not comprise xenogeneic components.