Host Cell Protein Quantitation by Lc-Ms. Experimental Demonstration, Qualification, and Comparison of Methods in Usp 1132.1

Chrone, Victor  Guldmann; Blaszczyk, Anthony  J.; Zhang, Derrick  H.; Nielsen, Solveig  B.; Crawford, Janne; Schwämmle, Veit; Højrup, Peter; Kofoed, Thomas; Peckham, Niomi; Mørtz, Ejvind

doi:10.2139/ssrn.5245701

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Host Cell Protein Quantitation by Lc-Ms. Experimental Demonstration, Qualification, and Comparison of Methods in Usp 1132.1

26 Pages Posted: 7 May 2025

See all articles by Victor Guldmann Chrone

Highlights• All three quantitative methods analyzed demonstrate linearity and high precision.• Methods meet all or most ICH Q2 (R2) criteria showing validation readiness.• Quantitative results are highly dependent on standard and method used.

Keywords: Host Cell Proteins (HCPs), Process-related impurities, Liquid Chromatography-Mass Spectrometry (LC-MS), Protein quantitation, Targeted analysis, Untargeted analysis

Suggested Citation: Suggested Citation

Chrone, Victor Guldmann and Blaszczyk, Anthony J. and Zhang, Derrick H. and Nielsen, Solveig B. and Crawford, Janne and Schwämmle, Veit and Højrup, Peter and Kofoed, Thomas and Peckham, Niomi and Mørtz, Ejvind, Host Cell Protein Quantitation by Lc-Ms. Experimental Demonstration, Qualification, and Comparison of Methods in Usp 1132.1. Available at SSRN: https://ssrn.com/abstract=5245701 or http://dx.doi.org/10.2139/ssrn.5245701