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

Library Number:
APNT134848391
Part Number:
720005379EN
Author(s):
Catalin E. Doneanu, Malcolm Anderson, Brad J. Williams, Matthew A. Lauber, Asish Chakraborty, and Weibin Chen
Source:
Waters
Content Type:
Application Notes
Content Subtype:
Application Notes
Related Products:
 
 
 
 

This application note demonstrates a generic and sensitive mass spectrometric assay for the identification and quantification of host cell proteins (HCPs) that are present in highly purified biotherapeutic monoclonal antibodies (mAbs), in the concentration range of 1 to 100 ppm.


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