Translational Medicine

QPS Delaware offers GYROS Assay Platform for GLP Bioanalysis in Support of Biologic and Biosimilar Drug Development Programs

In October 2010, QPS Delaware became one of the first CROs in North America to acquire a GyrolabTM xP workstation, an automated nano-scale immunoassay workstation. The unit, including the computer system, was integrated with the Watson LIMS system and validated in early 2011 to comply with 21 CFR Part 11. This state-of-the-art equipment enables QPS to provide rapid and cost effective services with a shorter turnaround time to meet the increasing demands of preclinical and clinical bioanalytical studies in the (bio)pharmaceutical industry.

Utilizing microfluidics technology, the GyrolabTM xP workstation is an automated, fluorescence-based system that automatically handles the analytical process from addition of capture reagent to detection of reactions. At the core of the GyrolabTMxP workstation is a compact disc (CD) which contains streptavidin-coated affinity capture columns. This immobilized solid phase provides sufficient but minimal sample/reagents interaction time and allows the desired interactions to take place while minimizing non-specific binding. The GyrolabTM xP workstation provides several advantages over traditional plate-based immunoassays: reduced sample and critical reagent volume (sample requires less than 3 µL); broad dynamic range (3 to 4 order of magnitude); improved precision (typically CV is less than 15%), and significantly reduced assay run time from 4-5 hours for a typical ELISA to less than one hour for 112 data points.

Since the acquisition of the GyrolabTM xP workstation, QPS’ translational medicine department has successfully developed several Gyro lab assays, including a TNFα assay for biomarker analysis, and a generic human IgG detection assay for PK analysis in support of therapeutic monoclonal antibody screening and discovery. Our scientists are skilled and well-trained with extensive hands-on experience. To date, we have successfully converted various existing ELISA assays into Gyro lab assays in a time- and cost-effective manner. Our proven track record of Gyro lab capability and expertise is demonstrated in two recent publications: (1) a poster entitled “Assessing Effects of Freeze-Thaw on Biotinylated Protein Molecules Using Gyro lab™,” presented at the 2012 AAPS NBC meeting (Liu, XF et al.; May 2012), where the reagent stability of a Gyro lab assay performance was reported; and (2) an original article entitled “Validation of a Gyro lab™ Assay for Quantification of Rituximab in Human Serum” published in the Journal of Pharmacological and Toxicological Methods (Liu, XF et al.; March, 2012). 

As the technology advances, the GyrolabTM xP workstation provides an attractive bioanalytical tool for efficient method development during the assay building stage as well as an automated immunoassay platform suitable for late phase clinical sample analysis where sample numbers are high, data quality is critical, and timelines are tight. QPS will be the quality CRO partner you can count on to help push your development programs forward. 

For inquiries, please contact:

Xun Wang, Ph.D. at Tel: (302) 369-5974 or xun.wang@qps-usa.com, or LingSing Chen, Ph.D. at Tel: (302) 453-5904 or lingsing.chen@qps-usa.com.

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