Multi-site N-glycan mapping study 1: Capillary electrophoresis – laser induced fluorescence

Ákos Szekrényes, Sung Ae Suhr Park, Marcia Santos, Clarence Lew, Aled Jones, Ted Haxo, Michael Kimzey, Shiva Pourkaveh, Zoltán Szabó, Zoran Sosic, Peng Feng, Csaba Váradi, François de l'escaille, Jean Bernard Falmagne, Preeti Sejwal, Thomas Niedringhaus, David Michels, Gordon Freckleton, Melissa Hamm, Anastasiya ManuilovMelissa Schwartz, Jiann Kae Luo, Jonathan van Dyck, Pui King Leung, Marcell Olajos, Yingmei Gu, Kai Gao, Wenbo Wang, Jo Wegstein, Samnang Tep, András Guttman

Research output: Contribution to journalArticle

20 Citations (Scopus)

Abstract

An international team that included 20 independent laboratories from biopharmaceutical companies, universities, analytical contract laboratories and national authorities in the United States, Europe and Asia was formed to evaluate the reproducibility of sample preparation and analysis of N-glycans using capillary electrophoresis of 8-aminopyrene- 1,3,6-trisulfonic acid (APTS)-labeled glycans with laser induced fluorescence (CE-LIF) detection (16 sites) and ultra highperformance liquid chromatography (UHPLC, 12 sites; results to be reported in a subsequent publication). All participants used the same lot of chemicals, samples, reagents, and columns/capillaries to run their assays. Migration time, peak area and peak area percent values were determined for all peaks with >0.1% peak area. Our results demonstrated low variability and high reproducibility, both, within any given site as well across all sites, which indicates that a standard N-glycan analysis platform appropriate for general use (clone selection, process development, lot release, etc.) within the industry can be established.

Original languageEnglish
Pages (from-to)56-64
Number of pages9
JournalmAbs
Volume8
Issue number1
DOIs
Publication statusPublished - Jan 1 2016

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Keywords

  • Biotherapeutics
  • Capillary electrophoresis
  • Intercompany study
  • N-glycans

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology

Cite this

Szekrényes, Á., Park, S. A. S., Santos, M., Lew, C., Jones, A., Haxo, T., Kimzey, M., Pourkaveh, S., Szabó, Z., Sosic, Z., Feng, P., Váradi, C., de l'escaille, F., Falmagne, J. B., Sejwal, P., Niedringhaus, T., Michels, D., Freckleton, G., Hamm, M., ... Guttman, A. (2016). Multi-site N-glycan mapping study 1: Capillary electrophoresis – laser induced fluorescence. mAbs, 8(1), 56-64. https://doi.org/10.1080/19420862.2015.1107687