Collagen IV binding assay for the detection of collagen VII

1. A method of detecting and/or quantifying collagen VII or a fragment thereof in a sample, the method comprising:

contacting the sample with collagen IV or a fragment thereof which binds to collagen VII; and

contacting the sample with an anti-collagen VII antibody, wherein the anti-collagen VII antibody consists of an antibody that binds to the NC2 domain of collagen VII;

detecting binding of the anti-collagen VII antibody to thereby detect and/or quantify an amount of collagen VII or the fragment thereof in the sample.

2. The method of claim 1 , wherein full length collagen VII is detected or quantified.

3. The method of claim 1 , wherein collagen VII or a fragment thereof comprising both the NC1 and NC2 domains is detected or quantified.

4. The method of claim 1 , further comprising subsequently contacting the sample with a second anti-collagen VII antibody, which binds to an epitope of collagen VII or a fragment thereof which is accessible after the binding of collagen VII or a fragment thereof to collagen IV or the fragment thereof, wherein the second anti-collagen VII antibody binds to the NC1 domain of collagen VII.

5. The method of claim 1 , further comprising contacting the sample with a second antibody, which binds to the anti-collagen VII antibody.

6. The method of claim 5 , comprising detecting the presence of the anti-collagen VII antibody.

7. The method of claim 5 , comprising quantifying the amount of anti-collagen VII antibody.

8. The method of claim 1 , further comprising measuring the level of collagen VII bound to collagen IV.

9. The method of claim 1 wherein, the collagen IV or the fragment thereof is disposed on a support.

10. The method of claim 1 wherein, the sample is a biological sample.

11. The method of claim 1 wherein, the sample is a drug product preparation or a drug substance preparation.

12. The method of claim 1 ,

wherein the anti-collagen VII antibody binds to an epitope of the NC2 domain of collagen VII, which is accessible after the binding of collagen VII or a fragment thereof to collagen IV or the fragment thereof.

13. A method of evaluating or processing a collagen VII sample, wherein the method comprises

acquiring an evaluation of the presence or amount of collagen VII;

providing a determination of whether the value determined meets a preselected criteria;

thereby evaluating or processing the collagen VII preparation, wherein the presence or amount of collagen VII is determined by a method comprising:

contacting the sample with collagen IV or a fragment thereof which binds to collagen VII;

contacting the sample with an anti-collagen VII antibody, wherein the anti-collagen VII antibody consists of an antibody that binds to the NC2 domain of collagen VII; and

detecting binding of collagen VII or a fragment thereof to collagen IV or the fragment thereof, to thereby detect and/or quantify the amount of collagen VII or the fragment thereof in the sample.

14. The method of claim 13 , wherein the method further comprises providing a comparison of the value determined with a reference value to thereby evaluate the sample.

15. The method of claim 13 , wherein the sample is further processed depending on whether a preselected relationship is met.

16. The method of claim 13 , wherein the anti-collagen VII antibody binds to an epitope of the NC2 domain of collagen VII or a fragment thereof which is accessible after the binding of collagen VII or a fragment thereof to collagen IV or the fragment thereof.

17. The method of claim 16 , further comprising contacting the sample with a second anti-collagen VII antibody, which binds to an epitope of collagen VII or a fragment thereof which is accessible after the binding of collagen VII or a fragment thereof to collagen IV or the fragment thereof, wherein the second anti-collagen VII antibody binds to the NC1 domain of collagen VII.