Anti-human IgG1 antibody

Patent metadata

Field	Value
Publication number	US-9766251-B2
Application number	US-201514627782-A
Country	US
Kind code	B2
Filing date	Feb 20, 2015
Priority date	Aug 17, 2010
Publication date	Sep 19, 2017
Grant date	Sep 19, 2017

Abstract

Herein are reported a monoclonal antibody specifically binding to a human IgG1 antibody and not specifically binding to the immunoglobulin of an experimental animal and the use of the antibody in immunoassays.

First claim

What is claimed:

1. A monoclonal antibody produced by the hybridoma cell line DSM ACC3076.

2. The monoclonal antibody of claim 1 , wherein the monoclonal antibody specifically binds to an antibody of human IgG1 class.

3. The monoclonal antibody of claim 1 , wherein the monoclonal antibody does not specifically bind to an immunoglobulin of rhesus monkey, marmoset monkey, baboon monkey, or cynomolgus monkey.

4. The monoclonal antibody of claim 1 , wherein the monoclonal antibody binds to an antibody of human IgG1 class having a kappa light chain.

5. The monoclonal antibody of claim 1 , wherein the monoclonal antibody binds to an antibody of human IgG1 class having a lambda light chain.

6. The monoclonal antibody of claim 1 , wherein the monoclonal antibody does not bind to an antibody of human IgG2 class, human IgG3 class, or human IgG4 class.

7. The monoclonal antibody of claim 1 , wherein the monoclonal antibody binds to the Fab of an antibody of human IgG1 class having a kappa light chain.

8. The monoclonal antibody of claim 1 , wherein the monoclonal antibody binds to the Fab of an antibody of human IgG1 class having a lambda light chain.

9. The monoclonal antibody of claim 1 , wherein the epitope comprises amino acid residues 16, 82, and 97 of SEQ ID NO:04.

10. The hybridoma cell line DSM ACC3076.

11. A kit comprising
a) an isolated monoclonal antibody produced by the hybridoma cell line DSM ACC3006, or produced by the hybridoma cell line DSM ACC 3007, or produced by the hybridoma cell line DSM ACC3008, or produced by the hybridoma cell line DSM ACC3076 for use in an immunoassay as capture reagent, and
b) an isolated monoclonal antibody produced by the hybridoma cell line DSM ACC3006, or produced by the hybridoma cell line DSM ACC 3007, or produced by the hybridoma cell line DSM ACC3008, or produced by the hybridoma cell line DSM ACC3076 for use in an immunoassay as detection reagent.

12. An antibody composition comprising a monoclonal antibody produced by the hybridoma cell line DSM ACC3076, and comprising one or more monoclonal antibodies selected from the group consisting of a monoclonal antibody produced by the hybridoma cell line DSM ACC3006, a monoclonal antibody produced by the hybridoma cell line DSM ACC3007, a monoclonal antibody produced by the hybridoma cell line DSM ACC3008, and a monoclonal antibody produced by the hybridoma the cell line DSM ACC2708.

13. A method for detecting the presence of a therapeutic antibody of human IgG1 class in a sample obtained from an experimental animal, the method comprising
a) obtaining a sample to be analyzed from the experimental animal,
b) incubating the sample with a capture antibody, wherein the capture antibody is selected from the group consisting of the monoclonal antibody produced by the hybridoma cell line DSM ACC3006, the monoclonal antibody produced by the hybridoma cell line DSM ACC3007, the monoclonal antibody produced by hybridoma cell line DSM ACC3008, and the monoclonal antibody produced by the hybridoma cell line DSM ACC2708, thereby forming a complex comprising the antibody of human IgG1 class and the capture antibody,
c) incubating the complex of the human antibody of IgG1 class and the capture antibody with a detection antibody, wherein the detection antibody is the monoclonal antibody of claim 1 , thereby forming a second complex comprising the antibody of human IgG1 class, the capture antibody, and the detection antibody, and
d) detecting the second complex, wherein the detection of the second complex correlates to the presence of the antibody of human IgG1 class, thereby detecting the presence of a therapeutic antibody of human IgG1 class in a sample obtained from an experimental animal.

14. The method of claim 13 , wherein detecting the second complex is by direct detection or by indirect detection.

15. A method for detecting the presence of a therapeutic antibody of human IgG1 class in a sample obtained from an experimental animal, the method comprising
a) obtaining a sample to be analyzed from the experimental animal,
b) incubating the sample with a capture antibody, wherein the capture antibody is the monoclonal antibody of claim 1 , thereby forming a complex comprising the antibody of human IgG1 class and the capture antibody,
c) incubating the complex of the antibody of human IgG1 class and the capture antibody with a detection antibody, wherein the detection antibody is selected from the group consisting of the monoclonal antibody produced by the hybridoma cell line DSM ACC3006, the monoclonal antibody produced by the hybridoma cell line DSM ACC3007, the monoclonal antibody produced by hybridoma cell line DSM ACC3008, and the monoclonal antibody produced by the hybridoma cell line DSM ACC2708, thereby forming a second complex comprising the antibody of human IgG1 class, the capture antibody, and the detection antibody, and
d) detecting the second complex, wherein the detection of the second complex correlates to the presence of the antibody of human IgG1 class, thereby detecting the presence of a therapeutic antibody of human IgG1 class in a sample obtained from an experimental animal.

16. The method of claim 15 , wherein detecting the second complex is by direct detection or by indirect detection.

17. A method for detecting the presence of a therapeutic antibody of human IgG1 class in a sample obtained from an experimental animal, the method comprising
a) obtaining a sample to be analyzed from the experimental animal,
b) incubating a biotinylated capture antibody to a streptavidin-coated microtiter plate, wherein the capture antibody is selected from the group consisting of the monoclonal antibody obtained from the hybridoma cell line DSM ACC3006, the hybridoma cell line DSM ACC3007, the hybridoma cell line DSM ACC3008, or the hybridoma cell line DSM ACC2708,
c) adding the sample to be analyzed to the microtiter plate, thereby forming a complex of the antibody of human IgG1 class and the biotinylated capture antibody bound to the streptavidin-coated microtiter plate,
d) incubating the complex in the microtiter plate with a detection antibody, thereby forming a second complex, wherein the second complex comprises the antibody of human IgG1 class, the biotinylated capture antibody, and the detection antibody, wherein the detection antibody is the monoclonal antibody of claim 1 , and
e) detecting the second complex, wherein the detection of the second complex correlates to the presence of the antibody of human IgG1 class, thereby detecting the presence of a therapeutic antibody of human IgG1 class in a sample obtained from an experimental animal.

18. The method of claim 17 , wherein detecting the second complex is by direct detection or by indirect detection.

19. The method of claim 17 , wherein the detection antibody is digoxygenylated.

20. The method of claim 19 , wherein the detecting is performed using a horseradish peroxidase labeled anti-digoxygenin antibody.

21. A method for detecting the presence of a therapeutic antibody of human IgG1 class in a sample obtained from an experimental animal, the method comprising
a) obtaining a sample to be analyzed from the experimental animal,
b) incubating a biotinylated capture antibody to a streptavidin-coated microtiter plate, wherein the capture antibody is the monoclonal antibody of claim 1 ,
c) adding the sample to be analyzed to the microtiter plate, thereby forming a complex of the antibody of human IgG1 class and the biotinylated capture antibody bound to the

Assignees

• Hoffmann La Roche

Inventors

• Essig Ulrich
• Klostermann Stefan
• Kowalewsky Frank
• Stubenrauch Kay-Gunnar
• Vogel Rudolf
• Wessels Uwe

Classifications

• C07K2317/33

  Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity · CPC title

• C07K16/4241

  against anti-human or anti-animal Ig · CPC title

• C07K2317/92

  Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value · CPC title

• C07K16/18

  against material from animals or humans · CPC title

• G01N33/686 Primary

  Anti-idiotype · CPC title