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Platform Analytical Procedures, beyond the technical challenges
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.
Opportunities and challenges from ICH Q2 (2) and Q14 for the analytical lifecycle
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.
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).
Peak Integration of Electropherograms in GMP and Research Labs: Navigating Increased Scrutiny Amid Data Integrity Audits and Inspections
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.
Universal Study Design for Instrument Changes in Pharmaceutical Release Analytics
Watch Author Insights | Boehringer Ingelheim's Dr. Anne Ries | Explore a practical benchmark example comparing two icIEF instruments, and gain a reusable framework to support lifecycle management of analytical methods in regulated environments.
Analytical Method Comparability Studies: Expert Panel Discussion on Instrument and Technology Changes
Panel Q&A | PDF download | Understand the practical distinctions between comparability, equivalence, and equality in the context of analytical method transitions, and learn how to frame study objectives and acceptance criteria accordingly.
The Use of Capillary Electrophoresis in Cell and Gene Therapy and Vaccine Development
4 November 2026 | Addressing emerging analytical challenges, evolving regulatory expectations, and potential solutions for developing robust, fit-for-purpose CE methods for next-generation CGT and vaccine products.
Prospective ICH Q2(R2)-Aligned Total-Error Validation of Label-Free Untargeted Proteomics for Host Cell Protein Quantification in Biotherapeutics
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.
Moving HCP LC-MS analysis into a GMP environment
On-Demand Presentation | Learn directly from Alphalyse's CEO | Understand the basic requirements for implementing a GMP-compliant LC-MS method for host cell protein analysis, including key considerations for alignment with USP 1132.1 and ICH guidelines.
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