Increasing Throughput for High Analytical Sensitivity Bioanalysis of Human Insulin and Its Biotherapeutic Analogs Using Microflow LC-MS/MS for Clinical Research

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Anthony Marcello, Michael Donegan, James Murphy, and Erin E. Chambers
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Recombinant human insulin and its analogs are well known as the standard of care for insulin dependent diabetes. With the increasing incidence of type 2 diabetes and limited alternative treatments, numerous insulin biosimilars are being developed. LC-MS has emerged as a key platform for quantification across the drug discovery and development continuum, showing advantages over ligand binding assays (LBAs) which are challenged with specificity issues and multiplexing capabilities. Previous work has highlighted the ability of microflow LC-MS using the ionKey/MS system as an effective approach to obtaining ultimate analytical sensitivity for insulin and its analogs with low sample volume.

Microflow LC-MS as an alternative to analytical scale is well known to address high analytical sensitivity requirements, yet often with the compromise of longer cycle times. Recent work has shown that the ionKey/MS system can achieve 3 minute cycle times with up to a 6-fold increase in analytical sensitivity when moving from analytical scale to microflow scale.

This work described herein, demonstrates that analytically sensitive, accurate, robust and high throughput bioanalytical analysis can be achieved with microflow regimes using the ionKey/MS system and 300 μm I.D. iKey HT Separation Device for insulin and five of its analogs extracted from human plasma for clinical research.

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