Scientific article

Development of a fast workflow to screen the charge variants of therapeutic antibodies

Published inJournal of chromatography, vol. 1498, p. 147-154
Publication date2017

Chemical or enzymatic modifications of therapeutic monoclonal antibodies (mAbs) having high risktowards safety and efficacy are defined as critical quality attributes (CQAs). During therapeutic mAbsprocess development, a variety of analytical techniques have to be used for the thorough characteriza-tion and quantitative monitoring of CQAs. This paper describes the development of a rapid analyticalplatform to assess and rank charge variants of mAbs. The workflow is first based on a cation exchangechromatography (CEX) comparative analysis of intact IgGs versus F(ab)'2 and Fc sub-domains generatedby IdeS digestion. This analytical procedure was validated with FDA and EMA approved mAbs. Then,functional assays and peptide mapping can be performed in a second instance. This approach can be usedduring the early stage of drug research and development to screen lead molecules and select optimizedcandidates (best clone, best formulation) which could be “easily” developed (OptimAbs).

  • Cation exchange chromatography
  • Charge variants
  • Developability
  • IdeS
  • Trastuzumaba
Citation (ISO format)
WAGNER-ROUSSET, Elsa et al. Development of a fast workflow to screen the charge variants of therapeutic antibodies. In: Journal of chromatography, 2017, vol. 1498, p. 147–154. doi: 10.1016/j.chroma.2017.02.065
Main files (1)
Article (Published version)
ISSN of the journal0021-9673

Technical informations

Creation04/25/2017 11:09:00 AM
First validation04/25/2017 11:09:00 AM
Update time03/15/2023 1:38:10 AM
Status update03/15/2023 1:38:09 AM
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