Platform switching from ELISA to Gyrolab™: a novel generic reagent omits the need to change critical reagents.

Bioanalysis

Roche Pharma Research & Early Development (pRED), Pharmaceutical Sciences, Global DMPK & Bioanalytical R&D, Roche Innovation Center Munich, Germany.

Published: April 2016

AI Article Synopsis

  • The study introduces a monoclonal antibody labeled with Alexa647(®) that can be used in both ELISA and Gyrolab™ assays, enhancing flexibility in biotherapeutics development.
  • This method maintains the accuracy, precision, and dynamic range typical of traditional Gyrolab™ assays.
  • In rat pharmacokinetic studies, this new approach yielded comparable results to both standard Gyrolab™ and ELISA methods, ensuring reliability across platforms.

Article 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-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-Alexa647(®) enables an easy switch between ELISA and Gyrolab™, providing an effective way to benefit from both platforms.

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Source
http://dx.doi.org/10.4155/bio-2015-0011DOI Listing

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