IDENTIFICATION AND QUANTIFICATION OF HOST CELL PROTEIN IMPURITIES IN HIGH PURITY MONOCLONAL ANTIBODIES DOWN TO 1 PPM: AN INTER-LABORATORY STUDY

Assay for Identification and Quantification of Host Cell Protein Impurities in High-Purity Monoclonal Antibodies Down to 1 ppm: An Inter-Laboratory Study Catalin E. Doneanu, Malcolm Anderson, Brad J. Williams, Matthew A. Lauber, Asish Chakraborty, and Weibin Chen Waters Corporation, Milford,…

Application Note Identification of Host Cell Proteins (HPCs) in Monoclonal Antibodies At Sub-ppm Levels Using the SYNAPT XS Mass Spectrometer Catalin E. Doneanu, Alexandre Gomes, Brad J. Williams, Ying Qing Yu, Weibin Chen Waters Corporation Abstract In this application note…

Advancing Host Cell Protein Analyses Through the Combined Use of Microscale 2D RP/RP with CSH C18 and Ion Mobility Enabled MS Detection Matthew A. Lauber, Catalin E. Doneanu, Stephan M. Koza, Weibin Chen, and Kenneth J. Fountain Waters Corporation, Milford,…

Application Note Enhanced Host Cell Protein Identification and Quantitation with Multi-Reflecting ToF LC-MS Jonathan Fox, Malcolm Anderson, Ying Qing Yu, Scott J Berger, Nick Pittman, Laetitia Denbigh Waters Corporation, United States Published on August 07, 2025 Abstract Host cell proteins…