Charles River Laboratories plays a key role in the discovery and nonclinical development of pharmaceuticals and our expertise in bioanalysis and biomarker measurement carries through to all stages of clinical development. Developing sensitive and specific biomarker, pharmacokinetic, and immunogenicity assays are required for success and Gyrolab platform has been valuable for the development and validation of the aforementioned assays to support both safe and efficacious therapies.
Leslie Kuiper, MS, Associate Scientist explains “Charles River has installed multiple Gyrolab workstations in many of our sites that perform bioanalytical assays for biologics in both North America and Europe to support global drug discovery and development. We have an extensive knowledge bank of experience and know-how in developing and validating (GLP-compliant) sensitive, selective, and reproducible methods for biotherapeutics of any size – peptides, recombinant proteins, monoclonal antibodies, and oligonucleotides, as well as anti-drug antibodies, cell therapies, and gene therapies – for nonclinical and clinical sample analysis.”
The automation of Gyrolab instrument helps to keep the assay results consistent over time and the automated liquid handlers greatly reduce the variability in steps critical to assay performance that would otherwise be done manually – capture, sample addition, and detection. In addition to reducing analyst-to-analyst variability, the liquid handler internal to Gyrolab systems also removes the possibility of inconsistent incubation times by injecting the appropriate reagents with the same timing to all segments on the CD. By minimizing inconsistencies associated with manual steps and incubation times, the use of Gyrolab systems limits two key sources in variability of results compared to data generated with manual assays and provides a more stable assay throughout pharmaceutical discovery and development.
Not only does automation lead to a more consistent assay, the automation of Gyrolab systems increases throughput compared to manual assays. As a CRO, the ability to increase throughput while reducing hands-on time is key to success. A single Gyrolab CD can provide up to 112 data points every 60 minutes! This far surpasses the typical plate-based ELISA, which can take 3 – 6 hours per run. By utilizing the full potential of a single Gyrolab workstation, 560 data points can be collected in an analyst’s shift with minimal hands-on time for the analyst. In addition to the large number of data points from a single run, due to the automated nature of Gyrolab systems, Charles River analysts can routinely set up a second round of analysis to be performed overnight, further increasing the throughput abilities compared to standard ELISA methods.
Gyrolab workstations are a valuable asset to Charles River for the development, validation and execution of biomarker, pharmacokinetic and immunogenicity assays for drug development. Robert Stachlewitz, PhD, DABT, CVP Global Lab Sciences notes “The Gyrolab system allows for improved assay consistency and throughput for therapeutic research compared to a plate-based ELISA. The Gyrolab platform enables Charles River to be one step ahead of many competitors and helps to keep us at the forefront of technology in drug development.”
About Charles River
Charles River provides essential products and services to help pharmaceutical and biotechnology companies, government agencies and leading academic institutions around the globe accelerate their research and drug development efforts. Our dedicated employees are focused on providing clients with exactly what they need to improve and expedite the discovery, early-stage development and safe manufacture of new therapies for the patients who need them. To learn more about our unique portfolio and breadth of services, visit www.criver.com.