Direct coupling of size exclusion chromatography and mass spectrometry for the characterization of complex monoclonal antibody products

Article Article scientifique Article Direct coupling of size exclusion chromatography and mass spectrometry for the characterization of complex monoclonal antibody products eng 2022-03-28 2022-03-28 author Murisier Amarande 805229 author Andrie Marie Josette Luce 850486 author Fekete Szabolcs 758546 author Lauber Matthew author D'Atri Valentina 0000-0002-2601-7092 846921 author Iwan Katharina author Guillarme Davy 623637 1997-2007 10.1002/jssc.202200075 35278285 1615-9306 PMC9311719 https://onlinelibrary.wiley.com/doi/10.1002/jssc.202200075 The present study describes the possibilities offered by an innovative bioinert size exclusion chromatography column for size variant characterization of complex monoclonal antibody products. This size exclusion chromatography column includes a novel column hardware surface. The column was prepared from metallic hardware components that were treated to have prototype hydrophilically modified hybrid organic-inorganic silica surfaces called hybrid surface technology. This provides a significant reduction in nondesired hydrophobic and electrostatic interactions that can occur between column and analyte when performing size exclusion chromatography analysis with volatile mobile phase. Compared to a reference stainless-steel column packed with the same batch of packing material, peak tailing, band broadening, and above all recovery of high molecular weight species were distinctly improved for all types of monoclonal antibody products. Based on our observations, we found that 50 mM ammonium acetate in water was a suitable mobile phase offering good compromise in terms of liquid chromatography performance and mass spectrometry sensitivity. In addition, method repeatability (intra- and interday relative standard deviations) on elution times and high molecular weight species peak areas were found to be excellent. By using this innovative size exclusion chromatography material, the low and high molecular weight species contained in various stressed and nonstressed monoclonal antibody products were successfully characterized with mass spectrometry detection. Bioinert columns Low adsorption column hardware Mass spectrometry Monoclonal antibodies Size-exclusion chromatography Dewey 615 31 Section des sciences pharmaceutiques 17 false 881 Sciences analytiques Journal of separation science 45 12 da77ee97-e09e-4567-80dc-5311b1a73974 Article (Published version) Public 2022 - Direct coupling of size excl1.pdf 1660602 application/pdf CC BY-4.0 openAccess Faculté des sciences / Section des sciences pharmaceutiques

Title	Published in	Access level	OA Policy	Year	Views	Downloads

Direct coupling of size exclusion chromatography and mass spectrometry for the characterization of complex monoclonal antibody products	Journal of separation science			2022	210	140

Archive ouverte UNIGE

Andrie, Marie Josette Luce