Remote Sampling Analysis of Immunosuppressant Drugs with LC-MS/MS

Traditional laboratory analysis of the immunosuppressant drugs cyclosporine, everolimus, sirolimus and tacrolimus is well-established in clinical research. However there remains a need for individuals to undergo an invasive, time-consuming and disruptive process under the supervision of trained staff in order to collect a sufficient volume of whole blood for laboratory analysis.

A reliable, remote sampling method may find utility in a clinical research setting. Here we describe the use of Capitainer® B Devices to obtain analytically sensitive, precise and accurate data for cyclosporine, everolimus, sirolimus and tacrolimus analysis using small sample volumes.

Using Capitainer® B devices and very sample small volumes (30 µL of whole blood resulting in a 10 µL dried blood spot), an in-house laboratory method was used on a LC-MS/MS system to meet validation goals for analytical sensitivity, linearity, precision and accuracy for cyclosporine, everolimus, sirolimus and tacrolimus. Furthermore, the advantages conferred by microsampling, notably removing the requirement for travel and a venous blood draw and facilitating home sampling, render this technique applicable to clinical research.

For Research Use Only. Not for Use in Diagnostic Procedures.

Learning objectives:

• Discover how the Xevo TQ Absolute can be used to achieve sufficient analytical sensitivity for a microsampling application
• Learn how to achieve fast sample throughput (~2 minute injection-to-injection), minimising time to first result
• Explore how MassTrak Immunosuppressant Calibrator and QC Sets can be included in the workflow

Presenter: Stephen Balloch (Senior Scientist, Clinical Scientific Operations, Waters Corporation)

Stephen Balloch graduated from the University of York (UK) with a Masters degree in Chemistry which included a strong focus on analytical chemistry and a year in industry, in which he gained experience in a range of analytical techniques.

His first permanent post was at Charles River Laboratories, a GLP compliant contract research laboratory in Edinburgh, in which he progressed to the role of Study Director and gained further exposure to LC-MS and LC-MS/MS instrumentation, including Waters instruments.

Since 2010, he has been part of the clinical team in the Scientific Operations group in Waters (Wilmslow, UK). His principal focus has been on the development and validation of bioanalytical methods according to CLSI guidelines, with a focus on therapeutic drug monitoring. Additionally, he has supported newborn screening, steroid and vitamin analysis.