title: Rapid development of multiple 'fit-for-purpose' assays on an automatic microfluidic system using a streamlined process in support of early biotherapeutics discovery programs.
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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Bioanalytical Sciences-Biologics, Analytical & Bioanalytical Development, Bristol-Myers Squibb, Princeton, NJ 08540, USA.
authors.forename: Rong
authors.initials: R
authors.lastname: Liu
authors.forename: Renuka
authors.initials: R
authors.lastname: Pillutla
authors.forename: Binodh
authors.initials: B
authors.lastname: DeSilva
authors.forename: Yan J
authors.initials: YJ
authors.lastname: Zhang
mesh_terms: D001331:Automation; D001688:Biological Products; D055808:Drug Discovery; D057230:Limit of Detection; D044085:Microfluidics / Q000295:instrumentation*
chemical_list: D001688:Biological Products