title: The Gyrolab™ immunoassay system: a platform for automated bioanalysis and rapid sample turnaround.
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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: BST, Drug Metabolism & Pharmacokinetics, GlaxoSmithKline, 709 Swedeland Road, King of Prussia, PA 19406, USA. kristy.j.fraley@gsk.com
authors.forename: Kristy J
authors.initials: KJ
authors.lastname: Fraley
authors.forename: Lee
authors.initials: L
authors.lastname: Abberley
authors.forename: Charles S
authors.initials: CS
authors.lastname: Hottenstein
authors.forename: John J
authors.initials: JJ
authors.lastname: Ulicne
authors.forename: David R
authors.initials: DR
authors.lastname: Citerone
authors.forename: Matthew E
authors.initials: ME
authors.lastname: Szapacs
mesh_terms: D000818:Animals; D001331:Automation; D007118:Immunoassay / Q000379:methods*; D008252:Macaca fascicularis; D012015:Reference Standards; D015203:Reproducibility of Results