Prospective ICH Q2(R2)-aligned total-error validation of label-free untargeted proteomics for host cell protein quantification in biotherapeutics
Somar Khalil, Jean‐François Dierick, Pascal Bourguignon, Michel Plisnier
This paper validates label-free untargeted proteomics for HCP quantification in biotherapeutics using ICH Q2(R2) total-error approach, showing high accuracy and precision across multiple assays and platforms.
Proteomes · Apr 23, 2026Peer-reviewedBiochemistry