Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2022 Mar;38(2):e3229.
doi: 10.1002/btpr.3229. Epub 2022 Jan 9.

Development and application of an analytical approach to assess an antibody's potential for disulfide reduction

Yanhong Yang  1 , Niutish Bastani  1 , Sara K Lagler  2 , Doug Harris  2 , Attila Nagy  2 , Peifeng Chen  3 , Aakash Patel  1 , Yile Li  1 , Daniel B Gowetski  2 , Q Paula Lei  1
Affiliations

Development and application of an analytical approach to assess an antibody's potential for disulfide reduction

Yanhong Yang et al. Biotechnol Prog. 2022 Mar.

Abstract

Monoclonal antibody (mAb) interchain disulfide bond reduction has been observed in a recent large-scale clinical manufacturing operation. A massive reduction/precipitation at post-clarification steps has occurred. This note presents the development of a novel analytical approach to identify the "potential reduction"-a unique approach to predict the propensity of a monomeric-profiled mAb to be reduced in the post-harvest stage, such as harvest clarification and/or purification steps. The core of this new approach includes comparing the non-reducing capillary electrophoresis profiles of pre- and post-vacuum treated mAb in harvest cell culture fluid (HCCF). Using this approach, the potential reductions of two in-house mAbs in the unclarified and clarified cell culture harvest were assessed.

Keywords: analytical approach; bio-separation; monoclonal antibody (mAb); potential reduction; vacuum chamber.

PubMed Disclaimer

References

REFERENCES

    1. Ruaudel J, Bertschinger M, Letestu S, Giovannini R, Wassmann P, Moretti P. Antibody disulfide bond reduction during process development: insights using a scale-down approach process. BMC Proc. 2015;9(Suppl 9):P24.
    1. Mullan B, Dravis B, Lim A, et al. Disulfide bond reduction of a therapeutic monoclonal antibody during cell culture manufacturing operations. BMC Proc. 2011;5(Suppl 8):P110.
    1. Trexler-Schmidt M, Sargis S, Chiu J, et al. Identification and prevention of antibody disulfide bond reduction during cell culture manufacturing. Biotechnol Bioeng. 2010;106(3):452-461.
    1. Hutterer KM, Hong RW, Lull J, et al. Monoclonal antibody disulfide reduction during manufacturing. MAbs. 2013;5(4):608-613.
    1. Wang T, Liu YQ, Cai B, Huang G, Flynn GC. Investigation of antibody disulfide reduction and re-oxidation and impact to biological activities. J Pharm Biomed Anal. 2015;102:519-528.

Publication types

LinkOut - more resources