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Last Updated: March 25, 2026

Claims for Patent: 10,759,866

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Summary for Patent: 10,759,866

Title:	Prevention of disulfide bond reduction during recombinant production of polypeptides
Abstract:	Provide herein are methods for preventing the reduction of disulfide bonds during the recombinant production of disulfide-containing polypeptides. In particular, the invention concerns the prevention of disulfide bond reduction during harvesting of disulfide-containing polypeptides, including antibodies, from recombinant host cell cultures.
Inventor(s):	Kao; Yung-Hsiang (San Mateo, CA), Laird; Michael W. (San Ramon, CA), Schmidt; Melody Trexler (Danville, CA), Wong; Rita L. (Redwood City, CA), Hewitt; Daniel P. (Sunnyvale, CA)
Assignee:	Genentech, Inc. (South San Francisco, CA)
Application Number:	16/240,592
Patent Claims:	1. A method for producing an antibody, comprising expressing the antibody in a Chinese Hamster Ovary (CHO) recombinant host cell culture, and following a production phase of the cell culture, sparging the pre-harvest cell culture fluid of the recombinant host cell with air to prevent reduction of a disulfide bond in the antibody during processing, wherein the antibody is a therapeutic monoclonal antibody that binds to CD20, and wherein the air sparging is continued until the amount of dissolved oxygen (dO.sub.2) in the pre-harvest cell culture fluid is at least 10%. 2. The method of claim 1, wherein the air sparging is continued until the pre-harvest cell culture fluid is at least 30% saturated with air. 3. The method of claim 1, wherein the air sparging is continued until the pre-harvest cell culture fluid is between 100% saturated to 30% saturated with air. 4. The method of claim 1, wherein the amount of dissolved oxygen (dO.sub.2) in the pre-harvest cell culture fluid is at least 30%. 5. The method of claim 1, wherein the antibody expressed in the recombinant host cell is produced at a scale of greater than 5,000 L. 6. The method of claim 1, further comprising preparing the harvested cell culture fluid of the recombinant host cell and recovering the antibody from the harvested cell culture fluid. 7. The method of claim 1, further comprising preparing the harvested cell culture fluid and purifying the antibody from the harvested cell culture fluid. 8. The method of claim 1, wherein the antibody that binds to CD20 is rituximab. 9. The method of claim 1, wherein the antibody that binds to CD20 is ocrelizumab.

Details for Patent 10,759,866

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Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	RITUXAN	rituximab	Injection	103705	November 26, 1997	10,759,866	2039-01-04
Idec Pharmaceuticals Corp.	RITUXAN	rituximab	Injection	103737	February 19, 2002	10,759,866	2039-01-04
Genentech, Inc.	OCREVUS	ocrelizumab	Injection	761053	March 28, 2017	10,759,866	2039-01-04
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

International Patent Family for US Patent 10,759,866

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Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2009009523	⤷ Start Trial
United States of America	8574869	⤷ Start Trial
United States of America	2025243291	⤷ Start Trial
United States of America	2024425610	⤷ Start Trial
United States of America	2024301080	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration

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