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Last Updated: April 26, 2024

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

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Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	12/31/2002	⤷ Try a Trial	2027-08-28
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	02/21/2008	⤷ Try a Trial	2027-08-28
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	04/24/2013	⤷ Try a Trial	2027-08-28
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	09/23/2014	⤷ Try a Trial	2027-08-28
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

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