“Transferring the assay to Gyrolab workstation gave us the robustness we needed to pass validation and rescue a GLP study.”
MPI Research acquired their first Gyrolab workstation in 2011, and the technology has since been used primarily for biomarker assays in pre-clinical studies. By the end of the first year, the CRO had already developed 25 novel assays using the system, and appreciated the small sample volumes and speed of assay development. This prompted them to acquire a second system in 2012.
Gyros technology has proved to be invaluable for MPI Research as Mark Cameron, Senior Manager Department of Biomarkers, Discovery Pharmacokinetics and Immunoassay Development, explains: “We had, for example, a PK study in monkeys that we were running on another vendor’s platform. The results were very variable and did not pass validation. Transferring the assay to Gyrolab workstation and using the same reagents gave us a robust assay that passed validation and rescued the GLP study. We ran 660 samples in 3 days. The original problems may well have been caused by matrix effects that are minimized by using Gyros technology”.
Speed in the CRO business is, of course, essential, so accelerated assay development is a real bonus. “There is a lot of labor associated with assay development. The assays run on Gyrolab workstation takes only about 70 minutes, compared with 3 – 5 hours on other platforms. Gyrolab workstation helps us to run several assay development experiments per day to shorten the time from assay concept to starting validation.”
Mark also greatly values the automation. “It’s a walk-away technology, while the other platforms we use are manual and very labor-intensive. The automation removes variability caused by the analyst and provides a very good statistical basis for our work. We like to run five CDs in a row if when possible. Set up takes a couple of hours in the morning and we then run the system for the day, collecting the data next morning. The data is fed into our Watson LIMS, which makes reporting and data management so much easier.”
Like many other CROs, MPI Research is finding that access to Gyros technology is often a prerequisite for business success. As Mark concludes, “Many of our clients have Gyrolab workstation and need to be able to readily transfer assays to us”.
MPI Research present themselves:
MPI Research, with global headquarters in Mattawan, Michigan, provides discovery, safety evaluation, bioanalytical, surgical services, medical device evaluation, and analytical services to the biopharmaceutical, biotech, medical device, animal health, and chemical industries. We exceed expectations through consistency and quality, with a commitment to communication and innovation, delivering benefits throughout all phases of development. Our key strengths are: single site facility, on-time reporting, experienced scientists, broad-scope of services, industry-leading animal welfare and enrichment, robust historical control database, real-time communication, and on-site pathologists. MPI Research is a high-quality organization that is committed to bringing safer and more effective products to the world.
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