Hi everyone,
We’d like to share an upcoming webinar that may be of interest to the community in here! On April 30, 2026 (16:00 CEST / 10:00 EDT), we are hosting a session on “Next-Gen HCP Analysis in Biopharma.”
Speakers:
Somar Khalil (GSK, Principal Scientist, Analytical Research & Development) — “Prospective ICH Q2(R2)-Aligned Total-Error Validation of Label-Free Untargeted Proteomics for Host Cell Protein Quantification in Biotherapeutics.”
Untargeted proteomics enables quantitative determination of host cell proteins (HCPs) in biotherapeutics, yet no workflow has been validated under ICH Q2(R2) for regulated quality control. Somar will present a prospective validation of label-free untargeted proteomics for HCP quantification using a total-error (TE) approach. The study demonstrates high quantitative performance (R² = 0.993), strong repeatability (median CV 2.7%), and robust intermediate precision across the validated range. Accuracy profiles show results well within ±30% acceptance limits, with an LLOQ of 20 ng and abundance-aware sensitivity down to low ppm levels. The workflow also shows strong robustness across software platforms and MS systems, supporting its applicability in regulated environments. This work represents the first ICH Q2(R2)-aligned validation of untargeted proteomics for HCP analysis, providing a statistical framework for broader adoption in biopharma quality control.
The webinar will focus on LC-MS-based approaches for next-generation HCP analysis, including untargeted quantification strategies, scalable sample preparation, and robust workflows designed for both research and regulated QC environments.
Registration & details:
https://attendee.gotowebinar.com/register/6138675027196437342?source=RDT
We hope this is relevant for those interested. The webinar is free and, in our eyes, a good opportunity for knowledge sharing. There is also an Q&A by the end of the webinar where we answer questions from the chat.
TL;DR: Webinar on April 30 about next-gen HCP analysis in biopharma, focusing on validated LC-MS workflows and untargeted proteomics for QC. Mods please delete if not allowed.