We are focusing development of all new assays towards sensitivity and high throughput analysis. Time and resource intensive processes of assay development and validation to FDA standards run alongside routine analysis of samples from small clinical studies in our development laboratory. High throughput methods are developed and implemented using automated sample preparation in combination with sensitive tandem mass spectrometry. The application of automated 96-well plates enables high-throughput approaches to biological sample preparation such as liquid-liquid extraction (LLE), solid-phase extraction (SPE), and protein precipitation (PPT). Sample preparation has always been a bottleneck for high-throughput especially when using manual extraction procedures. The implementation of our automated robotic liquid handling system Tecan Freedom EVO will speed up bioanalysis as measured by both the numbers of samples prepared per unit time and the analyst’s available time for other duties. All new assays are and will be implemented for analysis of samples from clinical studies and the capacity to handle large studies has grown each year since the start 2004 (see figure). The laboratory collaborates with many international research groups on analysis of the drugs in the biological sample and subsequent pharmacokinetic analysis. Non-proprietary methods that the laboratory can set-up are listed in the Assay List.

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