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Biotechnol Prog ; 38(2): e3229, 2022 03.
Article in English | MEDLINE | ID: mdl-34962716

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.


Subject(s)
Antibodies, Monoclonal , Disulfides , Animals , Antibodies, Monoclonal/chemistry , CHO Cells , Cell Culture Techniques , Cricetinae , Cricetulus , Disulfides/chemistry
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