A global comparability approach for biosimilar monoclonal antibodies using LC-tandem MS based proteomics

Shun Li Chen, Shiaw Lin Wu, Li Juan Huang, Jia Bao Huang, Shu Hui Chen

研究成果: Article同行評審

25 引文 斯高帕斯(Scopus)


Liquid chromatography-tandem mass spectrometry-based proteomics for peptide mapping and sequencing was used to characterize the marketed monoclonal antibody trastuzumab and compare it with two biosimilar products, mAb A containing D359E and L361M variations at the Fc site and mAb B without variants. Complete sequence coverage (100%) including disulfide linkages, glycosylations and other commonly occurring modifications (i.e., deamidation, oxidation, dehydration and K-clipping) were identified using maps generated from multi-enzyme digestions. In addition to the targeted comparison for the relative populations of targeted modification forms, a non-targeted approach was used to globally compare ion intensities in tryptic maps. The non-targeted comparison provided an extra-dimensional view to examine any possible differences related to variants or modifications. A peptide containing the two variants in mAb A, D359E and L361M, was revealed using the non-targeted comparison of the tryptic maps. In contrast, no significant differences were observed when trastuzumab was self-compared or compared with mAb B. These results were consistent with the data derived from peptide sequencing via collision induced dissociation/electron transfer dissociation. Thus, combined targeted and non-targeted approaches using powerful mass spectrometry-based proteomic tools hold great promise for the structural characterization of biosimilar products.

頁(從 - 到)126-135
期刊Journal of Pharmaceutical and Biomedical Analysis
出版狀態Published - 2013 6月

All Science Journal Classification (ASJC) codes

  • 分析化學
  • 藥學科學
  • 藥物發現
  • 光譜
  • 臨床生物化學


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