In:
Bioanalysis, Future Science Ltd, Vol. 5, No. 14 ( 2013-07), p. 1765-1774
Kurzfassung:
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.
Materialart:
Online-Ressource
ISSN:
1757-6180
,
1757-6199
Sprache:
Englisch
Verlag:
Future Science Ltd
Publikationsdatum:
2013
SSG:
15,3
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