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Poster Presentations
Day 2, June 23（Mon.）
Room P (Maesato East, Foyer, Ocean Wing)
- 2P-PM-08
A Comprehensive LC/MS Workflow for Host Cell Protein Identification Utilizing A Novel, Multi-reflecting ToF Mass Spectrometry Providing High Confidence Characterization And Quantification
(1Nihon Waters, 2Waters)
oEtsuko Yada1, Jonathan Fox2, Ying Qing Yu2, Kenji Hirose1
Host cell proteins (HCPs) are endogenous impurities that arise from expression systems during the production of biotherapeutics. Even in trace amounts (0.1-100 ppm), these impurities can trigger unwanted immune responses in patients or compromise the safety, efficacy, or stability of the therapeutic. This study outlines an analytical workflow for LC-MS analysis of HCPs in monoclonal antibodies (mAb) identifying proteins at sub ppm levels in the NIST Monoclonal Antibody Reference Material 8671 (NIST mAb) using a novel, multi-reflecting ToF MS combined with analytical scale UPLC separation of digested proteins. Key benefits of this benchtop MS include 4-5 order dynamic range, 100 K mass resolution, and high sensitivity, which help address some of the analytical challenges in HCP analysis.