title: Assay formats: Recommendation for best practices and harmonization from the global bioanalysis consortium harmonization team.
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.
authors.affiliation: Novartis Pharma AG, Novartis Institute for Biomedical Research, 144 Klybeckstrasse, 4052, Basel, Switzerland, sherri.dudal@roche.com.
authors.forename: Sherri
authors.initials: S
authors.lastname: Dudal
authors.forename: Daniel
authors.initials: D
authors.lastname: Baltrukonis
authors.forename: Rebecca
authors.initials: R
authors.lastname: Crisino
authors.forename: M Jaya
authors.initials: MJ
authors.lastname: Goyal
authors.forename: Alison
authors.initials: A
authors.lastname: Joyce
authors.forename: Karolina
authors.initials: K
authors.lastname: Osterlund
authors.forename: John
authors.initials: J
authors.lastname: Smeraglia
authors.forename: Yoshitaka
authors.initials: Y
authors.lastname: Taniguchi
authors.forename: Jihong
authors.initials: J
authors.lastname: Yang
mesh_terms: D003299:Cooperative Behavior; D004797:Enzyme-Linked Immunosorbent Assay; D008024:Ligands; D016133:Polymerase Chain Reaction; D017410:Practice Guidelines as Topic; D011863:Radioimmunoassay
chemical_list: D008024:Ligands