Gyros Protein Technologies AB has signed a distribution agreement with Euro Diagnostica, a full service assay solution company. The agreement will give Gyros Protein Technologies’ customers in Europe and North America direct access to the iLit assay ready cell lines from Euro Diagnostica, which help overcome limitations of conventional cell-based assays and improve productivity.
The iLite technology is based upon a unique reporter gene assay format, modified and adapted for applications through the whole drug development cycle as well as for monitoring of biological drugs. The applications addressed by iLite reporter gene assays are highly complementary to those addressed by Gyros Protein Technologies’ Gyrolab immunoassays systems, such as pharmacokinetics studies, detection of ADA (anti-drug antibodies) and bioprocess applications. The iLite dual reporter gene format allows for normalization of the response, eliminating unwanted matrix effects and compensating for differences in cell numbers, to achieve accurate and biologically relevant results. The cells are delivered frozen and assay ready, requiring no culture or maintenance, to enable cost reductions and time savings.
iLite assays have been designed to support screening of drug candidates, detection of neutralizing antibodies (NAb) as part of immunogenicity assessment, and potency measurements in manufacturing release tests. NAb are a subset of anti-drug antibodies (ADA) that bind to the therapeutic molecule resulting in its inhibition or complete neutralization, and affect the clinical efficacy of the drug. Detection and elimination of NAb is key to reducing the potential patient side effects of these unwanted drug components. The FDA recommends the use of cell-based neutralization assays over ligand-binding formats, when appropriate, as these more frequently provide physiologically relevant results.