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

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posted on 2023-03-24, 15:11 authored by Yue-Ting Wang, Estelle M Maes, Lance Heinle, Kenneth Ruterbories, Stella Doktor, Mary Larsen, Amanda Olson, Andrew Lee, Cecilia Van Hande, Qin C Ji, Kelly Desino, Gary J Jenkins

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.


This manuscriptwas sponsored by AbbVie. AbbVie contributed to the design, research and interpretation of data, writing, reviewing and approving the publication. All authors are employees of AbbVie. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.