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:
Part Number:
Catalin E. Doneanu, Malcolm Anderson, Brad J. Williams, Matthew A. Lauber, Asish Chakraborty, and Weibin Chen
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.

Title Format File Size
Download (720005379en) PDF 2925.53kB