Assay formats: Recommendation for best practices and harmonization from the global bioanalysis consortium harmonization team

AAPS J. 2014 Mar;16(2):194-205. doi: 10.1208/s12248-013-9552-9. Epub 2013 Dec 17.

Abstract

As part of the GBC (Global Bioanalysis Consortium), the L3 assay format team has focused on reviewing common platforms used to support ligand binding assays in the detection of biotherapeutics. The following review is an overview of discussions and presentations from around the globe with a group of experts from different companies to allow an international harmonization of common practices and suggestions for different platforms. Some of the major platforms include Gyrolab, Erenna, RIA, AlphaLISA, Delfia, Immuno-PCR, Luminex, BIAcore, and ELISAs. The review is meant to support bioanalysts in taking decisions between different platforms depending on the needs of the analyte with a number of recommendations to help integration of platforms into a GLP environment.

Publication types

  • Review

MeSH terms

  • Cooperative Behavior*
  • Enzyme-Linked Immunosorbent Assay
  • Ligands
  • Polymerase Chain Reaction
  • Practice Guidelines as Topic*
  • Radioimmunoassay

Substances

  • Ligands