QPS has extensive experience in developing and validating methods and assays for large molecules and gene therapies utilized in clinical and nonclinical sample analysis. Our vast experience is demonstrated in 21 validated methods using the Gyrolab immunoassay platform across more than 71 studies and over 106,000 samples. Our level of excellence in utilizing this equipment is evident in the >90% Run pass rate, and the >90% ISR pass rate.
Stacey Gottschall, QPS (Senior Team Lead) explains, “QPS has installed multiple Gyrolab workstations in our global drug development sites across both North America and Europe. We have continued to partner with Gyros Protein Technologies for the past 11 years, installing our first Gyrolab xP workstation in 2010, and the second one in 2018. We were the first CRO to partner with Gyros Protein Technologies and validate Gyrolab for GLP work in 2011. In addition, QPS added two Gyrolab xPlores in 2016 and we keep expanding, adding a Gyrolab xPand in 2020. We have also developed Standard Operating Procedures (SOPs) specifically for operation of the Gyrolab machines to ensure consistent results.”
QPS specializes in assay development and troubleshooting. Our typical process includes the following: testing multiple conditions, concurrently and in a short time period, to determine the best antibody pair and concentration using the binding profile images to gain a better understanding. The subsequent decrease in assay time allows data to be generated and reviewed, enabling additional experiments to be planned and tested within the same day. All of this ensures that we can qualify or validate the assay with optimal conditions.
A key specialty that QPS continues to refine is the ELISA to Gyrolab assay conversion. The similar format makes for a quick and easy conversion and validation. This capability also makes it easy to transfer the assay between QPS and the sponsor, while generating consistent results. It also significantly decreases assay time, improves and expands the assay range, while reducing potential matrix interference over multiple populations.
The improvements that have been observed with the Gyrolab assay conversion due to the systems automation include precision over time using multiple lots of CDs and reagents, reducing variability between operators by removing manual steps in the assay process and standardizing incubation times and sample and reagent volumes.
The high throughput is also a key to the success of the Gyrolab systems. When the system is used at full capacity, one analyst can generate 560 data points during their shift, and set up another run to be performed after-hours, resulting in a sustainable increase in efficiency and time savings. In addition, the results can be easily integrated into the Watson data collection system, further streamlining our processes.
Xun Wang, QPS Senior Director for Translational Medicine, says “Using Gyrolab methods to support clinical and nonclinical studies has many benefits for our Global Bioanalytical Teams. The Gyrolab workstations improve the efficiency of our analysts in the Lab and they help to keep us on the cutting edge of drug development techniques and ahead of the competition.”
QPS is a GLP- and GCP-compliant contract research organization (CRO) delivering the highest grade of discovery, preclinical, and clinical drug development services. Since 1995, it has grown from a tiny bioanalysis shop to a full-service CRO with 1,100+ employees in the U.S., Europe and Asia. Today, QPS offers expanded pharmaceutical contract R&D services with special expertise in neuropharmacology, DMPK, toxicology, bioanalysis, translational medicine and clinical development.
An award-winning leader focused on bioanalytics and clinical trials, QPS is known for proven quality standards, technical expertise, a flexible approach to research, client satisfaction, and turnkey laboratories and facilities. Through continual enhancements in capacities and resources, QPS stands tall in its commitment to delivering superior quality, skilled performance and trusted service to its valued customers. For more information, visit www.qps.com or email firstname.lastname@example.org.