Post by BioQC

Now available on BioQC: Article Spotlight on the first prospective ICH Q2(R2)-aligned validation of untargeted proteomics for host cell protein (HCP) quantification in biotherapeutics. Join authors Somar K. PhD, Jean-François Dierick PhD, Pascal Bourguignon BSc and Michel Plisnier from GSK as they present a regulatory-oriented validation framework that brings advanced LC-MS/MS proteomics workflows closer to routine biopharmaceutical quality control. In this article, you will learn: 🔹 How a Total Error framework combining trueness and precision enables a more comprehensive assessment of analytical performance under ICH Q2(R2) 🔹 How a dual-entrapment strategy was used to verify peptide identification error rates below 1%, strengthening confidence in data reliability 🔹 How abundance-stratified validation and cross-platform robustness testing support implementation across diverse laboratory environments Read the full article spotlight now: https://lnkd.in/eHUPHA_R #HCPAnalysis #Proteomics #LCMS #MassSpectrometry #ICHQ2 #MethodValidation #Biotherapeutics #AnalyticalDevelopment #QualityControl #CMC #BioQC #QualityExperts