Laboratory automation of high-quality and efficient ligand-binding assays for biotherapeutic drug development

Bioanalysis. 2013 Jul;5(13):1635-48. doi: 10.4155/bio.13.141.


Background: Regulated bioanalytical laboratories that run ligand-binding assays in support of biotherapeutics development face ever-increasing demand to support more projects with increased efficiency. Laboratory automation is a tool that has the potential to improve both quality and efficiency in a bioanalytical laboratory. The success of laboratory automation requires thoughtful evaluation of program needs and fit-for-purpose strategies, followed by pragmatic implementation plans and continuous user support.

Results: In this article, we present the development of fit-for-purpose automation of total walk-away and flexible modular modes. We shared the sustaining experience of vendor collaboration and team work to educate, promote and track the use of automation.

Conclusion: The implementation of laboratory automation improves assay performance, data quality, process efficiency and method transfer to CRO in a regulated bioanalytical laboratory environment.

MeSH terms

  • Antibodies, Monoclonal, Humanized / pharmacology
  • Automation, Laboratory / methods*
  • Biological Products / pharmacology*
  • Biomarkers / analysis*
  • Chemistry Techniques, Analytical / methods*
  • Denosumab
  • Drug Monitoring / methods*
  • Humans
  • Ligands
  • Quality Control


  • Antibodies, Monoclonal, Humanized
  • Biological Products
  • Biomarkers
  • Ligands
  • Denosumab