Methods for testing milk

• US 8,278,046 B2
• Filed: 04/05/2011
• Issued: 10/02/2012
• Est. Priority Date: 09/20/2005
• Status: Active Grant

• Current Assignee: Prolacta Bioscience Inc.
• Original Assignee: Prolacta Bioscience Inc.
• Inventors: Medo, Elena M., Lee, Martin L., Rechtman, David J.
• Primary Examiner(s): WHISENANT, ETHAN C
• Application Number:
  US13/079,932
• Publication Number:
  US 20110311689A1
• Time in Patent Office: 546 Days
• Field of Search: 424/520, 424/535, 435/6.1, 536/22.1
• US Class Current: 435/6.1
• CPC Class Codes: C12Q 1/6809 Methods for determination or identification of nucleic acids involving differential detection

Abstract

The disclosure is related generally to methods for testing mammary fluid (including milk) to establish or confirm the identity of the donor of the mammary fluid. Such methods are useful in the milk-bank business to improve safety.

Claims

1. A method for processing a donated human breast milk obtained from a specific subject comprising:

(a) testing a donated biological sample from the specific subject to obtain at least one reference identity marker profile for at least one marker;

(b) testing a sample of the donated human breast milk to obtain at least one identity marker profile for the at least one marker in step (a);

(c) comparing the identity marker profiles of steps (a) and (b), wherein a match between the identity marker profiles indicates that the donated human breast milk was obtained from the specific subject;

(d) processing the donated human breast milk whose identity marker profile has been matched with a reference identity marker profile, wherein the processing comprises;

(i) filtering the donated human breast milk;

(ii) heat treating the donated human breast milk;

(iii) separating the donated human breast milk into cream and skim;

(iv) adding a portion of the cream to the skim to form a human milk composition; and

(v) pasteurizing the human milk composition to produce a processed human breast milk composition.

2. A processed human milk composition suitable for administration to an infant made by the process of claim 1.

3. The method of claim 1 wherein the processed human breast milk composition comprises:

(a) a human protein constituent of 35-85 mg/mL

(b) a human fat constituent of 60-110 mg/mL

(c) a human carbohydrate constituent of 60-140 mg/mL.

4. The method of claim 1, wherein the method further comprises adding to the processed human breast milk one or more constituents selected from the group consisting of:

calcium, chloride, copper, iron, magnesium, manganese, phosphorus, potassium, sodium, and zinc.

5. The method of claim 1, wherein the testing of the donated human breast milk of step (b) and the testing of the donated biological sample of step (a) comprises nucleic acid typing.

6. The method of claim 5, wherein the nucleic acid typing comprises a method selected from the group consisting of:

STR analysis, HLA analysis, multiple gene analysis, and a combination thereof.

7. The method of claim 1, wherein the donated human breast milk sample of step (b) comprises a mixture of one or more breast milk samples from the specific subject.

8. The method of claim 1, wherein the testing of the donated human breast milk sample of step (b) and the testing of the donated biological sample of step (a) comprises antibody testing to obtain a self-antigen profile.

9. The method of claim 1, wherein the identity marker profiles obtained in steps (a) and (b) comprise peptide markers.

10. The method of claim 1, wherein the donated biological sample is selected from a group consisting of:

milk, saliva, buccal cell, hair root, and blood.

11. The method of claim 1, wherein lack of a match between the identity marker profiles obtained in steps (a) and (b) indicates contamination of the donated human breast milk sample.

12. The method of claim 1, wherein steps (a) through (c) are carried out at a human breast milk donation center or at a milk processing facility.

13. The method of claim 1, wherein steps (a) and (b) are carried out at different facilities.

14. The method of claim 13, wherein step (a) is carried out at a human breast milk donation facility and step (b) is carried out at a milk processing facility.

15. The method of claim 3 wherein the method further comprises adding the processed human breast milk composition to human breast milk to obtain a fortified human breast milk sample.