The AAPS Journal

, Volume 16, Issue 2, pp 194–205 | Cite as

Assay Formats: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team

  • Sherri Dudal
  • Daniel Baltrukonis
  • Rebecca Crisino
  • M. Jaya Goyal
  • Alison Joyce
  • Karolina Österlund
  • John Smeraglia
  • Yoshitaka Taniguchi
  • Jihong Yang
Review Article Theme: Best Practices for Bioanalytical Methods: Recommendations from the Global Bioanalysis Consortium
Part of the following topical collections:
  1. Theme: Best Practices for Bioanalytical Methods: Recommendations from the Global Bioanalysis Consortium

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.

KEY WORDS

assay format biotherapeutic large molecule platform technology 

Notes

Acknowledgements

We would like to acknowledge the input of Katherine Mckay (Covance, UK) and Mahesh Kumar (Biocon, India) in the early team sessions and their contribution to discussions.

Conflict of Interest

A possible conflict of interest would be the role of Karolina Österland in terms of Gyrolab input, but as this was a group-driven workstream and feedback from the international community, her opinion was mixed amongst the opinion of the LBA community.

Disclaimer

This article is representative of the expert opinions of the co-authors and the international community in the field of large molecule bioanalysis. It does not represent a single company viewpoint.

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Copyright information

© American Association of Pharmaceutical Scientists 2013

Authors and Affiliations

  • Sherri Dudal
    • 1
    • 2
  • Daniel Baltrukonis
    • 3
  • Rebecca Crisino
    • 4
  • M. Jaya Goyal
    • 5
  • Alison Joyce
    • 6
  • Karolina Österlund
    • 7
  • John Smeraglia
    • 8
  • Yoshitaka Taniguchi
    • 9
  • Jihong Yang
    • 10
  1. 1.Novartis Pharma AGNovartis Institute for Biomedical ResearchBaselSwitzerland
  2. 2.F. Hoffmann-La Roche LtdBaselSwitzerland
  3. 3.Pfizer Inc.GrotonUSA
  4. 4.Janssen, Research & Development, LLCRadnorUSA
  5. 5.Biogen IdecCambridgeUSA
  6. 6.Pfizer Inc.AndoverUSA
  7. 7.Gyros ABUppsalaSweden
  8. 8.UCB Parma S.ABraine-l’AlleudBelgium
  9. 9.Toray Research Center, Inc.Kamakura-shiJapan
  10. 10.GenentechSouth San FranciscoUSA

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