Development and Validation of a Peptide Mapping Method for the Characterization of Adalimumab with QDa Detector
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- 作者：Junjie Zhang ; Ting Qin ; Lu Xu ; Boning Liu ; Yantao Li ; Huaizu Guo…
- 关键词：LC–QDa ; Adalimumab ; CDR regions ; Peptide mapping
- 刊名：Chromatographia
- 出版年：2016
- 出版时间：April 2016
- 年：2016
- 卷：79
- 期：7-8
- 页码：395-403
- 全文大小：1,173 KB
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Ting Qin (1) (2) (3)
Lu Xu (1) (2) (3)
Boning Liu (1) (2) (3)
Yantao Li (2) (3)
Huaizu Guo (3) (4)
Lankun Song (6)
Qingcheng Guo (2) (3)
Jin Xu (3) (4)
Dapeng Zhang (2) (3)
Weizhu Qian (3) (4)
Jianxin Dai (2) (3)
Hao Wang (2) (3)
Sheng Hou (2) (3)
Yajun Guo (1) (3) (5)
1. School of Bioscience and Bioengineering, South China University of Technology, Guangzhou, China
2. International Joint Cancer Institute, Second Military Medical University, Shanghai, China
3. State Key Laboratory of Antibody Medicine and Targeted Therapy, Shanghai Key Laboratory of Cell Engineering, Shanghai, China
4. Shanghai Zhangjiang Biotechnology Co., Shanghai, China
6. Waters Corporation, Shanghai, China
5. School of Pharmacy, Liaocheng University, Liaocheng, China - 刊物类别：Chemistry and Materials Science
- 刊物主题：Chemistry
Analytical Chemistry
Organic Chemistry
Pharmacy
Biochemistry
Plant Sciences
Measurement Science and Instrumentation - 出版者：Vieweg Verlag
- ISSN：1612-1112
文摘
During antibody drug research and development, it is important to make sure the protein therapeutics are biosynthesized correctly, and peptide mapping works as a powerful analytical approach to confirm the identity of the monoclonal antibodies (mAbs). In this study, a novel quality control method combining tryptic peptide mapping with QDa detector for characterization of biotherapeutics was developed and validated. The peptides derived from complementarity determining regions (CDRs) of adalimumab were used as surrogates of adalimumab. Ten other antibody drugs were used to assess the method specificity. The results showed that this method has high specificity due to the high UV–MS selectivity; the limit of detection was 20 μg mL−1; carry-over was about 1.69 %. Additionally, other validation parameters, like stability, were also evaluated. This novel LC–UV–QDa method may be a simple, cost-effective and robust peptide-mapping method for other recombinant monoclonal antibodies during routine quality control analysis.