Integrity and efficiency: AbbVie’s journey of building an integrated nonregulated bioanalytical laboratory: Supplementary materials

While bioanalytical outsourcing is widely adopted in the pharmaceutical industry, AbbVie is one of the

few large biopharmaceutical companies having an internal bioanalytical unit to support nearly all its drug

metabolism and pharmacokinetic studies. This article highlights our experience and perspective in building

an integrated and centralized laboratory to provide early discovery and preclinical-stage bioanalytical

supportwith high operational efficiency, cost–effectiveness and data integrity. The advantages of in-house

nonregulated bioanalytical support include better control of data quality, faster turnaround times, realtime

knowledge sharing and troubleshooting, and lower near- and long-term costs. The success of an inhouse

model depends upon a comprehensively optimized and streamlined workflow, fueled by continuous

improvements and implementation of innovative technologies.