Standardized workflows for increasing efficiency and productivity in discovery stage bioanalysis.

Merck consolidated discovery stage bioanalytical functions into the Department of Pharmacokinetics, Pharmacodynamics & Drug Metabolism in 2007. Since then procedures and equipment used to provide important quantitative data to project teams have been harmonized and in many cases standardized. This approach has enabled movement of work across the network of laboratories and has resulted in a lean, flexible and efficient organization. The overall goal was to reduce time and resources spent on routine activities while creating time to perform research in new areas and technologies to support future scientific needs. The current state of discovery bioanalysis at Merck is discussed, including hardware and software platforms, workflow procedures and performance metrics. Examples of improved processes will be discussed for compound tuning, LC method development, analytical acceptance criteria, automated sample preparation, sample analysis platforms, data processing and data reporting.