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Meet the Expert: Mass Spectrometry for HCP Monitoring in GMP

Watch Author Insights | GSK's Dr. Somar Khalil | Move beyond aggregate immunoassay signals and validate untargeted, label-free mass spectrometry for individual-protein HCP monitoring in a GMP setting, grounded in ICH Q2(R2).

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Webinar

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

BioQC 23 September 2026 | GSK's Dr. Somar Khalil | This presentation describes the first validation of a label-free, untargeted proteomics method that meets ICH Q2(R2) expectations.

Expert Forum

Beyond GMP: Selecting and Managing CDMOs for Biological Products

BioQC 30 September 2026 | Articulate why regulatory compliance is an entry criterion, not a differentiator, and identify the three failure modes that standard audits consistently miss for biological products.

Expert Forum

Recent Advances in Process Analytical Technology (PAT) for Downstream and Upstream Processing

BioQC 9 December 2026 | PAT implementation, effects on yield, consistency, and scalability, and the roles of modelling and chemometrics in facilitating advanced monitoring and control strategies

Video Article

Meet the Expert: Mass Spectrometry for HCP Monitoring in GMP

BioQC Watch Author Insights | GSK's Dr. Somar Khalil | Move beyond aggregate immunoassay signals and validate untargeted, label-free mass spectrometry for individual-protein HCP monitoring in a GMP setting, grounded in ICH Q2(R2).

Video Article

Meet the Expert: Method Validation in Pharmaceutical Analysis

BioQC Watch Author Insights | Expert: Dr. Joachim Ermer | Move beyond checkbox compliance and master the full analytical lifecycle, from method design to routine verification, with purpose-driven validation grounded in ICH Q2 and Q14.

Article

Prospective ICH Q2(R2)-Aligned Total-Error Validation of Label-Free Untargeted Proteomics for Host Cell Protein Quantification in Biotherapeutics

BioQC Read Article Review | Access full paper | A regulatory-oriented framework that enables advanced LC-MS/MS proteomics workflows to move closer to routine biopharmaceutical quality control.

Video Article

Improvement of Peak Integration in Capillary Electrophoresis: Reference Data Set No. 1

BioQC Watch Author Insights | Marlon Krompholz | Explore the variability of manual peak integration and discover evidence-based strategies to improve analytical reproducibility.

Webinar

Platform Analytical Procedures, beyond the technical challenges

BioQC On-Demand Presentation | Learn from GSK experts to identify significant challenges and practical solutions for deploying and maintaining platform analytical procedures throughout different development and lifecycle stages.

Video Article

Peak Integration of Electropherograms in GMP and Research Labs: Navigating Increased Scrutiny Amid Data Integrity Audits and Inspections

BioQC Watch Author Insights | Expert: Dr. Timothy Blanc | Explore the current lack of regulatory guidance for electropherogram integration and discover how industry-wide harmonisation of guidelines, benchmarks, and software could strengthen analytical reliability.

Webinar

Opportunities and challenges from ICH Q2 (2) and Q14 for the analytical lifecycle

BioQC On-Demand Presentation | With experts from GSK | Assess the practical implications of established conditions for lifecycle flexibility and regulatory engagement, and gain a forward-looking perspective on how widespread adoption of these guidelines will shape the future of analytical lifecycle management.

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Meet the Expert: Mass Spectrometry for HCP Monitoring in GMP

Landing pages (11)

Untitled design (33)

Landing pages (10)

New Landing pages (5)

ICH-Logo

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

Beyond GMP: Selecting and Managing CDMOs for Biological Products

Recent Advances in Process Analytical Technology (PAT) for Downstream and Upstream Processing

Meet the Expert: Mass Spectrometry for HCP Monitoring in GMP

Meet the Expert: Method Validation in Pharmaceutical Analysis

Prospective ICH Q2(R2)-Aligned Total-Error Validation of Label-Free Untargeted Proteomics for Host Cell Protein Quantification in Biotherapeutics

Improvement of Peak Integration in Capillary Electrophoresis: Reference Data Set No. 1

Platform Analytical Procedures, beyond the technical challenges

Peak Integration of Electropherograms in GMP and Research Labs: Navigating Increased Scrutiny Amid Data Integrity Audits and Inspections

Opportunities and challenges from ICH Q2 (2) and Q14 for the analytical lifecycle

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