Characterization and elimination of artificial non-covalent light Chain dimers in reduced CE-SDS analysis of pertuzumab.

@article{Zhang2020CharacterizationAE,
  title={Characterization and elimination of artificial non-covalent light Chain dimers in reduced CE-SDS analysis of pertuzumab.},
  author={L. Zhang and Mengdan Fei and Y. Tian and Sipeng Li and Xiaoqi Zhu and L. Wang and Yanpeng Xu and M. H. Xie},
  journal={Journal of pharmaceutical and biomedical analysis},
  year={2020},
  volume={190},
  pages={
          113527
        }
}
Capillary electrophoresis sodium dodecyl sulfate (CE-SDS), either in reduced (rCE-SDS) or non-reduced (nrCE-SDS) form, is widely used for purity evaluation and impurity analysis of monoclonal antibody (mAb) drugs. The accuracy of the method may be interfered by artificial species resulted from sample preparation or electrophoresis operation if it is not well optimized. In a routine analysis of pertuzumab for both innovator Perjeta® and biosimilar HLX11 samples, a cluster of unknown peaks… Expand

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