Gyros’ technology overcomes matrix effects in a Phase III PK assay
It is not unusual for a pharmacokinetics assay used early on in a study proves to lack the robustness needed to see the drug candidate through to more advanced clinical studies. A team at Genentech experienced just that and they solved the problem by transferring their ELISA to the Gyrolab platform.
Genentech’s success with a humanized monoclonal antibody (mAb) that induced clinical remission in a Phase II trial encouraged them to move on to Phase III and also include a new disease indication. But the Phase III trial was threatened by the poor performance of their pharmacokinetics (PK) assay. The ELISA they had relied on for human PK studies in Phase I and II lacked the robustness demanded for smooth transfer to a contract research organization (CRO). The team quickly solved this critical problem by transferring the assay to the Gyrolab platform, resulting in a robust assay that could be readily transferred to the CRO for validation.
You can find out how by downloading the case study.