“Gyrolab® presents a robust platform for studies that require high throughput, have low sample volume, or have challenging analytes and matrices that are not easily analyzed with a traditional ELISA.”

 

ICON’s Bioanalytical Solutions takes very difficult targets in difficult matrices and develops highly robust and sensitive assays to support Sponsor programs. Gyrolab xP workstation helps ICON to achieve this, providing high throughput, phenomenal precision, and an open system to support method optimization and validation.

 

ICON Laboratory Services and Gyrolab

 ICON bioanalytical laboratories have a long history of supporting client’s precise immunoassay needs, including analysis on the Gyrolab xP system. The Gyrolab system strikes a good balance between automating the steps of an immunoassay for throughput and robustness, whilst still allowing flexibility to adjust methods to accurately quantitate a wide array of analytes in a variety of matrices.

Supporting all phases of drug development

ICON's team has supported numerous studies through all phases of drug development.

  • In one example, over the course of two weeks ICON analyzed 2,756 PK samples in a Phase 3 bioequivalence study using two Gyrolab xP workstations, running up to 20 CDs per day.
  • The inter-run %CV was less than or equal to 7.5%, and %RE ranged from 0.73% to 7.7%, 117/118 passed, and all ISRs met acceptance criteria.

Advantages of Gyrolab at ICON

Another clear advantage of the Gyrolab system is the ability to minimize the amount of sample volume used. ICON has used the Gyrolab to measure a biomarker with pg/mL sensitivity in nasosorption samples. They have also been able to take advantage of the Gyrolab’s low sample volume requirement for PK analysis of samples collected using dried blood spot micro-sampling techniques. The Gyrolab is an effective platform for conserving the limited volume of these types of samples.

About ICON Bioanalytical Laboratories:

ICON has earned a reputation for innovative method development and timely, high-quality analytical services that are personalized to meet each client’s specific application. Across laboratories in Assen, Netherlands, Lenexa, Kansas, and Whitesboro, New York, they provide both stand-alone immunoassay and mass spectrometry services, flow cytometry, qPCR, CMC, PD Biomarkers (LC-MS/MS & ELISA) as well as the bioanalytical component of full-service packages across all phases of development.

Find out more at www.iconplc.com/labs