Article
Early identification of unusually clustered mutations and root causes in therapeutic antibody development.
Biotechnology and bioengineering - 1 Sept 2018
Qian Yueming, Chen Zhiqiang, Huang Xin, Wang Xuning, Xu Xuankuo, Kirov Stefan, Ludwig Richard, Qian Nan-Xin, Ravi Kandasamy, Tao Li, Borys Michael C, Li Zheng Jian
Abstract excerpt
This study reports findings of an unusual cluster of mutations spanning 22 bp (base pairs) in a monoclonal antibody expression vector. It was identified by two orthogonal methods: mass spectrometry on expressed protein and next-generation sequencing (NGS) on the plasmid DNA. While the initial NGS analysis confirmed the designed sequence modification, intact mass analysis detected an additional mass of the...
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