Methods for testing milk

• US 7,943,315 B2
• Filed: 03/20/2008
• Issued: 05/17/2011
• Est. Priority Date: 09/20/2005
• Status: Active Grant

• Current Assignee: Prolacta Bioscience Inc.
• Original Assignee: Prolacta Bioscience Inc.
• Inventors: Lee, Martin L., Medo, Elena M., Rechtman, David J.
• Primary Examiner(s): WHISENANT, ETHAN C
• Application Number:
  US12/052,253
• Publication Number:
  US 20080227101A1
• Time in Patent Office: 1,153 Days
• Field of Search: 435/6, 435/91.2, 435/7.1
• 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 mammary fluid obtained from a specific subject, wherein the mammary fluid is human breast milk, the method 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 mammary fluid to obtain at least one identity marker profile for the at least one marker in step (a);

(c) comparing the identity marker profiles,

wherein a match between the identity marker profiles indicates that the mammary fluid was obtained from the specific subject;

(d) processing the donated mammary fluid whose identity marker profile has been matched with a reference identity marker profile, wherein the processed donated mammary fluid comprises a human protein constituent of 35-85 mg/mL;

a human fat constituent of 60-110 mg/mL; and

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

2. The method of claim 1, wherein processing comprises generating a pasteurized milk composition for administration to a human infant.

3. The method of claim 2, wherein the processing comprises

(a) filtering the milk;

heat-treating the milk;

(b) separating the milk into cream and skim;

(c) adding a portion of the cream to the skim; and

(d) pasteurizing.

4. The method of claim 1, wherein the processed donated mammary fluid further comprises 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 2, wherein processing comprises separating the milk into a cream portion and a skim portion, processing the cream portion, and pasteurizing the cream portion.

6. The method of claim 1, wherein the testing of the mammary fluid sample and the testing of the biological sample comprises a nucleic acid typing.

7. The method of claim 6, 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.

8. The method of claim 7, wherein the nucleic acid typing comprises STR analysis.

9. The method of claim 7, wherein the nucleic acid typing comprises HLA analysis.

10. The method of claim 7, wherein the nucleic acid typing comprises multiple gene analysis.

11. The method of claim 1, wherein the donated mammary fluid is frozen prior to testing.

12. The method of claim 11, further comprising obtaining the mammary fluid sample by drilling a core through the frozen fluid.

13. The method of claim 11, further comprising obtaining the mammary fluid sample by scraping the surface of the frozen mammary fluid.

14. The method of claim 1, wherein the mammary fluid sample comprises a mixture of one or more mammary fluid samples.

15. The method of claim 1, wherein the testing of the mammary fluid sample and the testing of the biological sample comprises antibody testing to obtain a self-antigen profile.

16. The method of claim 1, wherein the sample of the donated mammary fluid comprises a selected solid fraction of the fluid.

17. The method of claim 1, wherein the identity profiles comprise peptide markers.

18. 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.

19. The method of claim 18, wherein the donated biological sample comprises a blood sample.

20. The method of claim 18, wherein the donated biological sample comprises a buccal cell.

21. The method of claim 1, wherein lack of a match between the identity marker profiles indicates contamination of the mammary fluid by another mammal.

22. 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.

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

24. The method of claim 23, wherein step (a) is carried out at a donation facility and step (b) is carried out at a milk processing facility.