The Gyrolab™ immunoassay system: a platform for automated bioanalysis and rapid sample turnaround

Author:

Fraley Kristy J1,Abberley Lee2,Hottenstein Charles S2,Ulicne John J2,Citerone David R2,Szapacs Matthew E2

Affiliation:

1. BST, Drug Metabolism & Pharmacokinetics, GlaxoSmithKline, 709 Swedeland Road, King of Prussia, PA 19406, USA.

2. BST, Drug Metabolism & Pharmacokinetics, GlaxoSmithKline, 709 Swedeland Road, King of Prussia, PA 19406, USA

Abstract

Background: The Gyrolab™ workstation benefits from fully automated transfer of reagents and samples originating from a storage microplate onto a compact disc containing solid-phase microstructures composed of a 15 nl streptavidin-derivitized bead bed. Results: This paper describes the development, full validation and use of the method in a regulated environment to measure a humanized bispecific monoclonal antibody–domain antibody (GSK-A) molecule using the Gyrolab immunoassay system in cynomolgus nonhuman primate plasma ranging from 5 to 250 µg/ml. The method was subsequently used in support of the TK portion of a regulated preclinical study in monkeys. Conclusion: The Gyrolab immunoassay system proved to be a viable alternative to traditional immunoassays and was used to support a regulated preclinical TK study. The speed of analysis that the Gyrolab provides was beneficial in meeting timelines to complete this project as multiple assays and repeat sample analysis could be completed in the same day.

Publisher

Future Science Ltd

Subject

Medical Laboratory Technology,Clinical Biochemistry,General Pharmacology, Toxicology and Pharmaceutics,General Medicine,Analytical Chemistry

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