Rapid development of multiple 'fit-for-purpose' assays on an automatic microfluidic system using a streamlined process in support of early biotherapeutics discovery programs. (July 2013)

• Record Type: Journal Article
• Authors: Liu, Rong; Pillutla, Renuka; DeSilva, Binodh; Zhang, Yan J
• Is Part Of: Bioanalysis. Volume 5:Number 14(2013)
• Page Start: 1751
• Page End: 1763
• Publication Date: 2013-07
• Subjects: Drugs -- Analysis -- Periodicals; 615.19005
• DOI: 10.4155/bio.13.152
• Languages: English
• ISSNs: 1757-6180

Abstract

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.