A Prospective ICH Q2(R2) Validation of Untargeted Proteomics for Host Cell Protein Quantification
Event Overview
Mass spectrometry has transformed the characterisation of host cell protein impurities in biotherapeutics, yet no untargeted workflow has been formally validated under ICH Q2(R2) for use in regulated quality control.
This presentation describes the first validation of a label-free, untargeted proteomics method that meets ICH Q2(R2) expectations, built on a total-error framework that integrates accuracy, precision, and identification reliability. The work establishes a defined validated range, a lower limit of quantification, and verifies robustness to changes in software and instrumentation.
Attendees will gain a clear view of how high-dimensional analytical methods can be moved from discovery into regulated environments, with a transferable framework applicable to other product modalities and impurity classes.
Key Learning Outcomes
- Apply the total-error and accuracy-profile framework to high-dimensional MS data, including β-expectation tolerance intervals.
- Use dual entrapment to empirically control peptide-level identification error beyond theoretical target-decoy estimates.
- Define a practical LLOQ for untargeted HCP methods using stratified accuracy profiling.
- Take home a transferable statistical workflow for ICH Q2(R2) validation of MS-based untargeted methods, with built-in robustness checks across software and platform.
What you need to know:
Dual-ime broadcast, with starting times as follows:
Wednesday, 23 September 2026
- Broadcast #1 (Europe/Asia): 10:00 h BST (London) / 11:00 h CEST (Paris/Berlin) / 14:30 h IST (New Delhi) / 17:00 h SGT (Singapore) / 18:00 h JST (Tokyo)
- Broadcast #2 (North America / Europe): 08:00 h PDT (Los Angeles) / 11:00 h EDT (New York) / 16:00 h BST (London) / 17:00 h CEST (Paris/Berlin)
Duration: Approximately 60 – 90 minutes, incl. Q&A.
Who should attend?
Analytical scientists working on host cell protein quantification; biopharmaceutical QC and method validation specialists; MS proteomics method developers; and regulatory CMC professionals.
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Somar KhalilPrincipal ScientistGSK (Technical Research & Development), BelgiumSomar Khalil is a Principal Scientist at GSK Vaccines in the Mass Spectrometry and NMR group, Technical R&D. His work focuses on MS-based proteomics and mRNA analytics, with expertise in LC-MS host-cell protein quantification, glycoproteomics, and implementation of advanced LC-MS workflows in regulated settings. He has led method development and validation for HCP monitoring in vaccine and biologics programs, applying statistical modelling and data science to support CMC decision-making.
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Dr. Ewoud van TrichtScientific DirectorBioQCExpert in (bio)pharmaceutical analysis with over 18 years of industrial experience in analytical development, Quality Control, and Analytical Quality by Design (AQbD). He has contributed to diverse therapeutic modalities, including small molecules, viruses, and cells, at leading companies such as Janssen Vaccines and Sanofi Cell Therapy.
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