Article
Characterization of alanine to valine sequence variants in the Fc region of nivolumab biosimilar produced in Chinese hamster ovary cells.
mAbs - 1 Jul 2016
Li Yantao, Fu Tuo, Liu Tao, Guo Huaizu, Guo Qingcheng, Xu Jin, Zhang Dapeng, Qian Weizhu, Dai Jianxin, Li Bohua, Guo Yajun, Hou Sheng, Wang Hao
Abstract excerpt
Nivolumab is a therapeutic fully human IgG4 antibody to programmed death 1 (PD-1). In this study, a nivolumab biosimilar, which was produced in our laboratory, was analyzed and characterized. Sequence variants that contain undesired amino acid sequences may cause concern during biosimilar bioprocess development. We found that low levels of sequence variants were detected in the heavy chain of the nivolumab...
Topics
- Alanine
- Animals
- Antibodies, Monoclonal
- Biosimilar Pharmaceuticals
- CHO Cells
- Cricetinae
- Cricetulus
- Genetic Variation
- Immunoglobulin Fc Fragments
- Nivolumab
- Peptide Mapping
- Valine