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

The AAPS Journal
Sherri DudalJihong Yang

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.

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Citations

Nov 21, 2014·Bioanalysis·Nobuhiro Kobayashi
Jun 14, 2015·Journal of Computer-aided Molecular Design·Hermann WätzigSami El Deeb
Oct 3, 2014·The AAPS Journal·Philip TimmermanTatsuo Kurokawa
Oct 22, 2014·The AAPS Journal·Saloumeh K FischerAlvydas Mikulskis
May 11, 2017·Bioanalysis·Stéphanie Simon, Eric Ezan
Dec 13, 2019·Bioanalysis·Douglas DonaldsonLauren F Stevenson
Dec 2, 2020·Bioanalysis·Padmanabhan EangoorVincenzo Pucci
Jun 7, 2021·Veterinary Immunology and Immunopathology·Carol G Chitko-McKownBrian V Lubbers

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