Acid-induced aggregation propensity of nivolumab is dependent on the Fc.
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ABSTRACT:
SUBMITTER: Liu B
PROVIDER: S-EPMC4968106 | biostudies-literature | 2016 Aug-Sep
REPOSITORIES: biostudies-literature
Publications
Acid-induced aggregation propensity of nivolumab is dependent on the Fc.
Liu Boning B Guo Huaizu H Xu Jin J Qin Ting T Xu Lu L Zhang Junjie J Guo Qingcheng Q Zhang Dapeng D Qian Weizhu W Li Bohua B Dai Jianxin J Hou Sheng S Guo Yajun Y Wang Hao H
mAbs 20160616 6
Nivolumab, an anti-programmed death (PD)1 IgG4 antibody, has shown notable success as a cancer treatment. Here, we report that nivolumab was susceptible to aggregation during manufacturing, particularly in routine purification steps. Our experimental results showed that exposure to low pH caused aggregation of nivolumab, and the Fc was primarily responsible for an acid-induced unfolding phenomenon. To compare the intrinsic propensity of acid-induced aggregation for other IgGs subclasses, tociliz ...[more]
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