US 11,999,791 B2
Prevention of disulfide bond reduction during recombinant production of polypeptides
Yung-Hsiang Kao, San Mateo, CA (US); Michael W. Laird, San Ramon, CA (US); Melody Trexler Schmidt, Danville, CA (US); Rita L. Wong, Redwood City, CA (US); and Daniel P. Hewitt, Sunnyvale, CA (US)
Assigned to Genentech, Inc., South San Francisco, CA (US)
Filed by Genentech, Inc., South San Francisco, CA (US)
Filed on May 1, 2023, as Appl. No. 18/310,448.
Application 18/310,448 is a division of application No. 17/087,313, filed on Nov. 2, 2020, granted, now 11,639,395.
Application 15/488,917 is a division of application No. 14/043,758, filed on Oct. 1, 2013, abandoned.
Application 14/043,758 is a division of application No. 13/354,223, filed on Jan. 19, 2012, granted, now 8,574,869, issued on Nov. 5, 2013.
Application 17/087,313 is a continuation of application No. 16/847,317, filed on Apr. 13, 2020, granted, now 10,906,986, issued on Feb. 2, 2021.
Application 16/847,317 is a continuation of application No. 16/240,592, filed on Jan. 4, 2019, granted, now 10,759,866, issued on Sep. 1, 2020.
Application 16/240,592 is a continuation of application No. 15/488,917, filed on Apr. 17, 2017, abandoned.
Application 13/354,223 is a continuation of application No. 12/217,745, filed on Jul. 8, 2008, abandoned.
Claims priority of provisional application 60/948,677, filed on Jul. 9, 2007.
Prior Publication US 2023/0365704 A1, Nov. 16, 2023
This patent is subject to a terminal disclaimer.
Int. Cl. C07K 16/28 (2006.01); A61K 39/395 (2006.01); A61P 5/00 (2006.01); A61P 37/02 (2006.01); C07K 1/14 (2006.01); C07K 1/22 (2006.01); C07K 14/00 (2006.01); C07K 16/32 (2006.01); C12N 1/38 (2006.01); C12N 5/00 (2006.01)
CPC C07K 16/2887 (2013.01) [A61K 39/39591 (2013.01); C07K 1/14 (2013.01); C07K 2317/24 (2013.01)] 43 Claims
 
1. A method for the prevention of the reduction of a disulfide bond in a therapeutic IgG1 antibody expressed by a recombinant Chinese Hamster Ovary (CHO) host cell, comprising, following fermentation, lowering the pH of the harvested cell culture fluid (HCCF) of the recombinant CHO host cell, wherein lowering the pH of the HCCF results in prevention of the reduction of the disulfide bond in the antibody, and wherein the pH is lowered to a value of less than pH 6.