A Prospective ICH Q2(R2) Validation of Untargeted Proteomics for Host Cell Protein Quantification

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Presenter

Somar Khalil Principal Scientist GSK (Technical Research & Development), Belgium Somar 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.

Moderator

Dr. Ewoud van Tricht Scientific Director BioQC Expert 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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