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

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Abstract

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.

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Acknowledgments

This work was supported by grants from the Natural Science Foundation of China (81330061), Ministry of Science and Technology of China (973 projects 2010CB833605 and 863 projects 2011AA020114, 2014AA021004), State Key Project for New Drug Development (2013ZX09101021; 2013ZX09401303), Shanghai Rising-Star Program, Shanghai Key Laboratory of Cell Engineering (14DZ2272300), Shanghai Key technologies R&D Program of Biological medicine (15431906100) and Shanghai Excellent technical leader (13XD1424000).

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    Authors and Affiliations

    1. School of Bioscience and Bioengineering, South China University of Technology, Guangzhou, China

      Junjie Zhang, Ting Qin, Lu Xu, Boning Liu & Yajun Guo

    2. International Joint Cancer Institute, Second Military Medical University, Shanghai, China

      Junjie Zhang, Ting Qin, Lu Xu, Boning Liu, Yantao Li, Qingcheng Guo, Dapeng Zhang, Jianxin Dai, Hao Wang & Sheng Hou

    3. State Key Laboratory of Antibody Medicine and Targeted Therapy, Shanghai Key Laboratory of Cell Engineering, Shanghai, China

      Junjie Zhang, Ting Qin, Lu Xu, Boning Liu, Yantao Li, Huaizu Guo, Qingcheng Guo, Jin Xu, Dapeng Zhang, Weizhu Qian, Jianxin Dai, Hao Wang, Sheng Hou & Yajun Guo

    4. Shanghai Zhangjiang Biotechnology Co., Shanghai, China

      Huaizu Guo, Jin Xu & Weizhu Qian

    5. School of Pharmacy, Liaocheng University, Liaocheng, China

      Yajun Guo

    6. Waters Corporation, Shanghai, China

      Lankun Song

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    1. Junjie Zhang
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    Correspondence to Sheng Hou or Yajun Guo.

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    On behalf of all authors, the corresponding author states that there is no conflict of interest.

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    J. Zhang, T. Qin and L. Xu have contributed equally to this work.

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    Zhang, J., Qin, T., Xu, L. et al. Development and Validation of a Peptide Mapping Method for the Characterization of Adalimumab with QDa Detector. Chromatographia 79, 395–403 (2016). https://doi.org/10.1007/s10337-016-3046-8

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