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Last Updated: October 16, 2019

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Claims for Patent: 8,969,024

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Summary for Patent: 8,969,024
Title:Compositions and methods comprising binding proteins for adalimumab
Abstract: Compositions and methods comprising proteins that bind specifically to adalimumab are disclosed herein. Adalimumab is a monoclonal antibody specific for the cytokine TNF-.alpha. and was developed to treat TNF-.alpha. mediated inflammatory diseases. In one aspect of the instant invention, the binding proteins are antibodies directed toward adalimumab. These antibodies, including binding fragments thereof, can be used in a clinical setting as well as for research and development. For example, these anti-adalimumab antibodies can be employed to neutralize adalimumab.
Inventor(s): Kaymakcalan; Zehra (Westborough, MA), Xiong; Limin (Shrewsbury, MA)
Assignee: AbbVie Biotechnology Ltd (Hamilton, BM)
Application Number:12/229,788
Patent Claims:1. An isolated anti-adalimumab monoclonal antibody, or an antigen binding portion thereof, wherein said antibody is antibody 5A1-2A8, produced by a hybridoma having ATCC accession no. PTA-8513, or an antigen-binding portion thereof.

2. The antibody, or an antigen binding portion thereof, of claim 1 which is a Fab fragment or a single chain antibody.

3. A method of detecting adalimumab in a sample, said method comprising contacting said sample with the antibody, or antigen-binding portion thereof, of claim 1 under conditions suitable for antibody-antigen complex formation, and detecting a presence of the antibody-antigen complex formation, wherein detection of the complex indicates the presence of adalimumab in the sample.

4. The method of claim 3, wherein said detecting is selected from the group consisting of EIA (enzyme immunoassay), ELISA (enzyme linked immunosorbent assay), RIA (radioimmunoassay), indirect competitive immunoassay, direct competitive immunoassay, non-competitive immunoassay, sandwich immunoassay, and agglutination assay.

5. A kit comprising isolated anti-adalimumab monoclonal antibody 5A1-2A8, produced by a hybridoma having ATCC Accession No. PTA-8513, or an antigen-binding portion thereof.

6. The kit of claim 5 further comprising a control antibody, wherein said control antibody does not react with adalimumab or a fragment thereof.

7. A hybridoma cell line deposited under ATCC accession number PTA-8512.

8. An isolated anti-adalimumab monoclonal antibody, or an antigen binding portion thereof, wherein said antibody is 1H11-2E10, produced by a hybridoma having ATCC accession No. PTA-8512, or an antigen-binding portion thereof.

9. The antibody, or an antigen binding portion thereof, of claim 8 which is a Fab fragment or a single chain antibody.

10. A method of detecting adalimumab in a sample, said method comprising contacting said sample with the antibody, or antigen-binding portion thereof, of claim 8 under conditions suitable for antibody-antigen complex formation, and detecting a presence of the antibody-antigen complex formation, wherein detection of the complex indicates the presence of adalimumab in the sample.

11. The method of claim 10, wherein said detecting is selected from the group consisting of EIA (enzyme immunoassay), ELISA (enzyme linked immunosorbent assay), RIA (radioimmunoassay), indirect competitive immunoassay, direct competitive immunoassay, non-competitive immunoassay, sandwich immunoassay, and agglutination assay.

12. A kit comprising isolated anti-adalimumab monoclonal antibody 1H11-2E10, produced by a hybridoma having ATCC Accession No. PTA-8512, or an antigen-binding portion thereof.

13. The kit of claim 12 further comprising a control antibody, wherein said control antibody does not react with adalimumab or a fragment thereof.

14. A hybridoma cell line deposited under ATCC accession number PTA-8513.

Details for Patent 8,969,024

Applicant Tradename Biologic Ingredient Dosage Form BLA Number Approval Date Patent No. Assignee Estimated Patent Expiration Status Orphan Source
Abbvie Inc HUMIRA adalimumab SYRINGE 125057 001 2002-12-31   See Pricing AbbVie Biotechnology Ltd (Hamilton, BM) 2027-08-28 RX search
Abbvie Inc HUMIRA adalimumab VIAL 125057 002 2002-12-31   See Pricing AbbVie Biotechnology Ltd (Hamilton, BM) 2027-08-28 RX search
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Number >Approval Date >Patent No. >Assignee >Estimated Patent Expiration >Status >Orphan >Source

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