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Updated: May 9, 2026
High-throughput Protein Expression Generator Using a Microfluidic Platform
Published on: August 23, 2012
Rapid development of multiple 'fit-for-purpose' assays on an automatic microfluidic system using a streamlined
Rong Liu1, Renuka Pillutla, Binodh DeSilva
1Bioanalytical Sciences-Biologics, Analytical & Bioanalytical Development, Bristol-Myers Squibb, Princeton, NJ 08540, USA.
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.
