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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.
Prospective ICH Q2(R2)-Aligned Total-Error Validation of Label-Free Untargeted Proteomics for Host Cell Protein Quantification in Biotherapeutics
Spotlight | A regulatory-oriented framework that enables advanced LC-MS/MS proteomics workflows to move closer to routine biopharmaceutical quality control.
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.
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.
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.
Regulatory expectations for your HCP analysis: meet USP <1132.1> to enhance the quality of MS-based data
On-Demand Presentation | Incl. panellist from U.S. Pharmacopeia (USP) | Compare the pros and cons of the three HCP quantification methods outlined in USP 1132.1, and gain insight into how LC-MS/MS enables more specific identification and quantification of individual HCPs beyond what traditional ELISA approaches can provide.
Peak Integration of Electropherograms in GMP and Research Labs: Navigating Increased Scrutiny Amid Data Integrity Audits and Inspections
Meet the 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.
Explore the key success factors and implementation challenges in LIMS deployment
On-Demand Presentation by Ramon de Groot (Limes Lab Support) | Understand how modern LIMS enforces ALCOA+ principles and has evolved from basic sample tracking into a central laboratory data management platform integrating with instruments, ELN, and ERP systems.
A Practical Approach to Implementing ICH Q14: Tools for Analytical Quality by Design in Capillary Electrophoresis Method Development
Meet the Expert: Dr. Ewoud van Tricht | Discover how capillary electrophoresis, developed using Design of Experiments, can replace slower techniques like qPCR for adenovirus quantification, cutting analysis time from days to under an hour.
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