Mass spectrometry-based assays are rapidly becoming the gold standard for the analysis of insulin analogues and their biosimilars, and increasingly are requested by regulatory authorities during clinical trials for new therapies, due to their specificity. The sensitivity of the Xevo TQ-XS, combined with immunoaffinity extraction and UPLC is a powerful combination for these demanding compounds.
In this webinar we describe the approach, the opportunities and pitfalls, and provide robustness and precision data from multiple clinical trials.
What will you learn?
- Acceptance criteria for hybrid assays, discussion and current practice.
- Sensitivity requirements and throughput needs for insulin assays by LC–MS.
- Growing interest in hybrid assays for biological molecules.
- Advantages of mass spectrometry assays.
- Performance of the Xevo TQ-XS in high-throughput clinical analysis.
Who will this interest?
- Users of Waters triple quadrupole mass spectrometers.
- Companies providing assays for peptides and biosimilar molecules.
- Method developers and managers interested in the characteristics of hybrid IA-LC–MS approaches.
- Quality assurance personnel wishing to learn more about hybrid assays for biological molecules.
Meet our speaker
Bioanalytical Scientist, Method DevelopmentARCINOVA (Alnwick,UK)l;Michael completed postgraduate work at the University of Wales (Bangor, UK) and began work for the government in the UK, measuring the concentrations of pollutants in aquatic samples by gas and later liquid chromatography-mass spectrometry. He later joined the pharmaceutical industry with Sanofi (Guildford, UK), as a mass spectrometrist, doing bioanalytical and drug metabolism studies. Since then he has worked as a Principle Investigator and Head of Method Development at Covance (Alnwick, UK) and latterly for ARCINOVA as a method developer. The development of better insulin assays using hybrid MS approaches has been a major interest for about 10 years.