Development and Validation of a Peptide Mapping Method for the Characterization of Adalimumab with QDa Detector

作者：Zhang, Junjie; Qin, Ting; Xu, Lu; Liu, Boning; Li, Yantao; Guo, Huaizu; Song, Lankun; Guo, Qingcheng; Xu, Jin; Zhang, Dapeng; Qian, Weizhu; Dai, Jianxin; Wang, Hao; Hou, Sheng^*; Guo, Yajun^*

来源：Chromatographia, 2016, 79(7-8): 395-403.

DOI：10.1007/s10337-016-3046-8

• LC-QDa
• Adalimumab
• CDR regions
• Peptide mapping

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 mu g 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.

• 出版日期2016-4
• 单位中国人民解放军第二军医大学; 聊城大学; 华南理工大学