Platform Switching from ELISA to Gyrolab™: A Novel Generic Reagent Omits The Need to Change Critical Reagents

Abstract

During development of biotherapeutics, availability of specific assay reagents is usually limited. The possibility to switch from one ligand binding assay technology to another, while using the same reagents, would be desirable. Here, we report on an Alexa647(®)-labeled monoclonal antibody against digoxigenin (mAb<Dig>-Alexa647(®)) that enables the detection of digoxigenylated analyte-specific ELISA reagents by Gyrolab(™). In an analysis of non-monoclonal antibody (mAb) and mAb drugs, this approach maintained the dynamic range, accuracy and precision of the standard Gyrolab™ approach using analyte-specific Alexa647(®)-labeled Ab. In a rat PK study, results of our approach, standard Gyrolab™ and ELISA were comparable, with difference values within the incurred sample reanalysis acceptance criteria. Therefore, mAb<Dig>-Alexa647(®) enables an easy switch between ELISA and Gyrolab™, providing an effective way to benefit from both platforms.

Use of a Microfluidic Platform To Evaluate and Predict Reagent Performance in Microtiter Plate-Based Immunoassays

“…Microfluidics-based immunoassays emerge as an attractive, complementary option to meet challenges as described above primarily due to its small-scale operating volumes, low consumption of precious reagents (and samples), and ease with which to automate the workflow of the multistep immunoassays. − Indeed, microfluidic components and designs are part of various formats of SPR-based techniques, including Biacore. While the landscape of microfluidic immunoassays in development and in commercial markets is highly diverse, − the relatively mature, commercial Gyrolab system is a versatile microfluidic technique that can potentially address most of these requirements outlined above to support the screening and generation of critical immunoassay reagents. − …”