Methods for testing milk

• US 8,628,921 B2
• Filed: 08/23/2012
• Issued: 01/14/2014
• Est. Priority Date: 09/20/2005
• Status: Expired

• 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:
  US13/592,678
• Publication Number:
  US 20130064940A1
• Time in Patent Office: 509 Days
• Field of Search: 435/6.1, 536/22.1, 536/23.1, 536/24.3, 426/7, 426/585, 426/665, 426/801, 514/1
• 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 determining whether a donated mammary fluid was obtained from a specific subject, 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; and

(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 11-20 mg/mL;

a human fat constituent of 35-55 mg/mL; and

a human carbohydrate constituent of 70-120 mg/mL.

2. The method of claim 1, wherein the mammary fluid is human breast milk.

3. The method of claim 1 wherein the processing comprises:

(a) filtering the milk;

(b) heat-treating the milk;

(c) separating the milk into cream and skim;

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

(e) pasteurizing.

4. The method of claim 1, wherein the composition 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 1, 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, further comprising nucleic acid typing, 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 mammary fluid is frozen.

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

9. 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.

10. 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.

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

12. The method of claim 11, wherein step (a) is carried out at a human breast milk donation facility and step (b) is carried out at a milk processing facility.

13. 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;

and wherein the processed donated human breast milk comprises a human protein constituent of 11-20 mg/mL;

a human fat constituent of 35-55 mg/mL; and

a human carbohydrate constituent of 70-120 mg/mL.

14. A processed human milk composition suitable for administration to an infant made by the process of claim 13.

15. The method of claim 13, 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.

16. The method of claim 13, 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 selected from the group consisting of:

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

17. The method of claim 13, wherein the donated biological sample is selected from a group consisting of:

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

18. The method of claim 13, wherein steps (a) through (c) are carried out at a human breast milk donation center or at a milk processing facility.

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

20. The method of claim 19, wherein step (a) is carried out at a human breast milk donation facility and step (b) is carried out at a milk processing facility.