From proof of concept to the routine use of an automated and robust multi-dimensional liquid chromatography mass spectrometry workflow applied for the charge variant characterization of therapeutic antibodies
作者: Alexandre GoyonLu DaiTao ChenBingchuan WeiFeng YangNisana AndersenRobert KopfMichael LeissMichael MølhøjDavy GuillarmeCinzia Stella
作者单位: 1School of Pharmaceutical Sciences, University of Geneva, University of Lausanne, Centre Médical Universitaire (CMU), Rue Michel-Servet 1, 1206, Geneva, Switzerland
2Protein Analytical Chemistry, Genentech, 1 DNA Way, South San Francisco, CA 94080, USA
3Small Molecule Pharmaceutical Sciences, Genentech, 1 DNA Way, South San Francisco, CA 94080, USA
4F. Hoffmann-La Roche, Grenzacherstrasse 124, 4070 Basel, Switzerland
5Roche Pharma Technical Development, Nonnenwald 2, 82377 Penzberg, Germany
6Roche Pharma Research and Early Development, Roche Innovation Center Munich, Nonnenwald 2, 82377 Penzberg, Germany
刊名: Journal of Chromatography A, 2020, Vol.1615
来源数据库: Elsevier Journal
DOI: 10.1016/j.chroma.2019.460740
关键词: AutomationCharge variantsMonoclonal antibodiesMulti-dimensional chromatographyPTM
原始语种摘要: Abstract(#br)The identification and quantification of post-translational modifications (PTMs) is a crucial step required during the development of therapeutic proteins. In particular, the characterization of charge variants separated by cation exchange chromatography (CEX) is a tedious process commonly performed with an off-line manual fraction collection followed by peptide mapping. To improve the efficiency of this time-consuming approach, a generic on-line multi-dimensional LC/MS approach was developed for the characterization of various monoclonal antibody (mAb) isotypes and a bi-specific antibody (BsAb). Fractions collected from 1 D CEX analysis were consecutively reduced on a 2 D reversed phase liquid chromatography (RPLC) column (polyphenyl), digested within 1–2 min using a 3 D...
全文获取路径: Elsevier  (合作)
影响因子:4.612 (2012)

  • dimensional 量纲的
  • chromatography 色层分离法
  • therapeutic 治疗的
  • workflow 工作流
  • deamidation 脱氨基
  • liquid 液体
  • quantification 量化
  • column 
  • translational 平移的
  • robust 牢固的