Assay for Identification and Quantification of Host Cell Protein Impurities in High-Purity Monoclonal Antibodies Down to 1 ppm: An Inter-Laboratory Study

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,…

IDENTIFICATION AND QUANTIFICATION OF HOST CELL PROTEIN IMPURITIES IN HIGH PURITY MONOCLONAL ANTIBODIES DOWN TO 1 PPM: AN INTER-LABORATORY STUDY Catalin Doneanu1, Scott J. Berger1, Malcolm Anderson2, Brad Williams3, Matt Lauber1, Asish Chakraborty1 and Weibin Chen1 1 Waters Corporation, Milford,…

[ APPLICATION NOTE ] A Comprehensive Approach for HCP Identification, Quantification, and Monitoring Based on a Single Dimension (1D) LC Separation Catalin Doneanu, 1 Sarah Lennon, 2 Malcolm Anderson, 2 Ian Reah, 3 Mal Ross, 3 Steven Anderson, 3 Ian…

Evaluating 2D-RP/RP Fractionation Capabilities of the ACQUITY UPLC M-Class System with 300-µm I.D. Configuration Catalin E. Doneanu, Asish Chakraborty, Patricia Young and Weibin Chen Waters Corporation, Milford, MA, USA A P P L I C AT I O N B…