Current Advances and Strategies Towards Fully Automated Sample Preparation for Regulated LC–MS/MS Bioanalysis

Abstract

Robotic liquid handlers (RLHs) have been widely used in automated sample preparation for liquid chromatography–tandem mass spectrometry (LC–MS/MS) bioanalysis. Automated sample preparation for regulated bioanalysis offers significantly higher assay efficiency, better data quality and potential bioanalytical cost-savings. For RLHs that are used for regulated bioanalysis, there are additional requirements, including 21 CFR Part 11 compliance, software validation, system qualification, calibration verification and proper maintenance. This article reviews recent advances in automated sample preparation for regulated bioanalysis in the last 5 years. Specifically, it covers the following aspects: regulated bioanalysis requirements, recent advances in automation hardware and software development, sample extraction workflow simplification, strategies towards fully automated sample extraction, and best practices in automated sample preparation for regulated bioanalysis.

Financial & competing interests disclosure

The authors of this article are current employees of Bristol-Myers Squibb Company (BMS). All financial support for the studies reported herein was provided by BMS. The authors have no further relevant affiliations or financial involvement with any other organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties. No writing assistance was utilized in the production of this manuscript.

Acknowledgements

The authors would like to thank Mark E Arnold and Anne-Francoise Aubry (Analytical & Bioanalytical Development, Bristol-Myers Squibb Company, Princeton, NJ 08540, USA) for their review of this manuscript.