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.
A Practical Approach to Implementing ICH Q14: Tools for Analytical Quality by Design in Capillary Electrophoresis Method Development
Watch Author Insights | BioQC's 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.
Meet the Expert: Method Validation in Pharmaceutical Analysis
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.
Improvement of Peak Integration in Capillary Electrophoresis: Reference Data Set No. 1
Watch Author Insights | Marlon Krompholz | Explore the variability of manual peak integration and discover evidence-based strategies to improve analytical reproducibility.
Separation of virus-like particles and nano-emulsions for vaccine development by Capillary Zone Electrophoresis
Watch Author Insights | Merck's Dr. Adam Sutton | Learn practical strategies for developing and validating a single CZE method capable of simultaneously characterising nanoparticles, surfactants, and small molecules in multi-component pharmaceutical formulations.
A Comprehensive Evaluation of Analytical Method Parameters Critical to the Reliable Assessment of Therapeutic mRNA Integrity by Capillary Gel Electrophoresis
Watch Author Insights | Health Canada's Dr. Huixin Lu | Understand how key method parameters, including denaturant type, LNP disruption strategy, and sample preparation, critically influence mRNA integrity results measured by CGE-LIF.
Advancing Reversed-Phase Chromatography Analytics of Influenza Vaccines Using Machine Learning Approaches on a Diverse Range of Antigens and Formulations
Watch Author Insights | Health Canada's Dr. Huixin Lu | Discover how machine learning can automate the classification of reversed-phase chromatograms for influenza vaccines, reducing reliance on manual interpretation and accelerating method development.
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