Simple, Reproducible & Robust Bioassays In Cryopreserved Ready-To-Assay Format
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Cell-based bioassays often pose a hurdle during a rapidly moving biologics development program. High standards for assay accuracy, precision, reproducibility and robustness are additionally put to the test by the use of continuous culture cells that can add to assay variability and increase the cost and complexity of each assay. Advent of new technology platforms can enable rapid development of cell-based bioassays that are simple, accurate, precise and robust. Here, we discuss the development and application of diverse PathHunter® cell-based assays that cover distinct cellular mechanisms either distal from or proximal to the receptor. These quantitative assays are highly specific, scalable, robust and utilize a homogenous mix-and-read protocol, which facilitates rapid and reproducible detection of drug potency. In order to increase the reproducibility and reduce the complexity of the assay by eliminating cell culture, these assays are developed as cryopreserved ready-to-assay cells that can be plated directly from the frozen state onto the assay plate. The cell preparation, bioassay protocol and reagents have been optimized to provide superior bioassay performance with high reproducibility (<10%RSD). Examples discussed here include assays for Bevacizumab, human growth hormone, and GLP1 receptor agonists.