BACKGROUND: With a rapid increase in the number of novel biotherapeutic programs in the pipelines, efficient development of ligand-binding assays for PK and PD studies in the early discovery stage has become more important than ever. METHODOLOGY: A four-step process was evaluated to quickly develop multiple 'fit-for-purpose' Gyrolab(®) ligand-binding assays in parallel. It covered the following four steps: reagent labeling, reagent screening, assay optimization; and, assay qualification. RESULTS: Eight assays for two programs were developed and qualified in less than 2 weeks. These assays met the specifications of sufficient sensitivity with LLOQ between 2 and 50 ng/ml, %CV <25% and recoveries between 75 and 125% for QC samples. CONCLUSION: The streamlined four-step process enabled timely development of multiple high-throughput assays in parallel with minimal hands-on time. Consequently, it dramatically increased assay development productivity to support the discovery programs.
BACKGROUND: With a rapid increase in the number of novel biotherapeutic programs in the pipelines, efficient development of ligand-binding assays for PK and PD studies in the early discovery stage has become more important than ever. METHODOLOGY: A four-step process was evaluated to quickly develop multiple 'fit-for-purpose' Gyrolab(®) ligand-binding assays in parallel. It covered the following four steps: reagent labeling, reagent screening, assay optimization; and, assay qualification. RESULTS: Eight assays for two programs were developed and qualified in less than 2 weeks. These assays met the specifications of sufficient sensitivity with LLOQ between 2 and 50 ng/ml, %CV <25% and recoveries between 75 and 125% for QC samples. CONCLUSION: The streamlined four-step process enabled timely development of multiple high-throughput assays in parallel with minimal hands-on time. Consequently, it dramatically increased assay development productivity to support the discovery programs.