Integrity and efficiency: AbbVie's journey of building an integrated nonregulated bioanalytical laboratory

被引：5

作者：

Wang, Yue-Ting ^{[1
]}

Maes, Estelle M. ^{[1
]}

Heinle, Lance ^{[1
]}

Ruterbories, Kenneth ^{[1
]}

Doktor, Stella ^{[1
]}

Larsen, Mary ^{[1
]}

Olson, Amanda ^{[1
]}

Lee, Andrew ^{[1
]}

Van Handel, Cecilia ^{[1
]}

Ji, Qin C. ^{[1
]}

Desino, Kelly ^{[1
]}

Jenkins, Gary J. ^{[1
]}

机构：

[1] AbbVie, 1 North Waukegan Rd, N Chicago, IL 60064 USA

来源：

BIOANALYSIS | 2023年 / 15卷 / 03期

关键词：

ADME; automation; DMPK; nonregulated bioanalysis; pharmacokinetics; PK; process optimization; quality control; streamlined workflow; HIGH-THROUGHPUT; DRUG; ASSAY; DISCOVERY; AUTOMATION; ENTITIES; SUPPORT;

D O I：

10.4155/bio-2023-0012

中图分类号：

Q5 [生物化学];

学科分类号：

071010 ; 081704 ;

摘要：

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 support with 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, real-time knowledge sharing and troubleshooting, and lower near- and long-term costs. The success of an in-house model depends upon a comprehensively optimized and streamlined workflow, fueled by continuous improvements and implementation of innovative technologies.

引用

页码：161 / 176

页数：16

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