Skip to main content
SpringerLink
Log in

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

  • Review Article
  • Theme: Best Practices for Bioanalytical Methods: Recommendations from the Global Bioanalysis Consortium
  • Published:
The AAPS Journal Aims and scope Submit manuscript

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.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. Myler HA, Given A, Kolz K, Mora JR, Hristopoulos G. Biotherapeutic bioanalysis: a multi-indication case study review. Bioanalysis. 2011;3(6):623–43 [Review].

    Article  CAS  PubMed  Google Scholar 

  2. US Department of Health and Human Services, Food and Drug administration, CDER, CVM. Guidance for Industry, Bioanalytical Method Validation, 2001.

  3. DeSilva B, Smith W, Weiner R, Kelley M, Smolec J, Lee B, et al. Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules. Pharm Res. 2003;20(11):1885–900 [Guideline].

    Article  CAS  PubMed  Google Scholar 

  4. Fast DM, Kelley M, Viswanathan CT, O’Shaughnessy J, King SP, Chaudhary A, et al. Workshop report and follow-up–AAPS Workshop on current topics in GLP bioanalysis: assay reproducibility for incurred samples—implications of Crystal City recommendations. AAPS J. 2009;11(2):238–41 [Review].

    Article  PubMed Central  PubMed  Google Scholar 

  5. Smolec J, DeSilva B, Smith W, Weiner R, Kelly M, Lee B, et al. Bioanalytical method validation for macromolecules in support of pharmacokinetic studies. Pharm Res. 2005;22(9):1425–31 [Review Validation Studies].

    Article  CAS  PubMed  Google Scholar 

  6. Viswanathan CT, Bansal S, Booth B, DeStefano AJ, Rose MJ, Sailstad J, et al. Quantitative bioanalytical methods validation and implementation: best practices for chromatographic and ligand binding assays. Pharm Res. 2007;24(10):1962–73 [Consensus Development Conference].

    Article  CAS  PubMed  Google Scholar 

  7. European Medicines Agency. Guideline on Bioanalytical Method Validation, 2009.

  8. Leary BA, Lawrence-Henderson R, Mallozzi C, Fernandez Ocana M, Duriga N, O’Hara DM, et al. Bioanalytical platform comparison using a generic human IgG PK assay format. J Immunol Methods. 2013;397(1–2):28–36.

    Article  CAS  PubMed  Google Scholar 

  9. Soderstrom CI, Spriggs FP, Song W, Burrell S. Comparison of four distinct detection platforms using multiple ligand binding assay formats. J Immunol Methods. 2011;371(1–2):106–13 [Comparative Study Evaluation Studies].

    Article  CAS  PubMed  Google Scholar 

  10. Forster RJ, Bertoncello P, Keyes TE. Electrogenerated chemiluminescence. Annu Rev Anal Chem (Palo Alto Calif). 2009;2:359–85 [Review].

    Article  CAS  Google Scholar 

  11. Lewkowich IP, Campbell JD, HayGlass KT. Comparison of chemiluminescent assays and colorimetric ELISAs for quantification of murine IL-12, human IL-4 and murine IL-4: chemiluminescent substrates provide markedly enhanced sensitivity. J Immunol Methods. 2001;247(1–2):111–8 [Comparative Study Research Support, Non-U.S. Gov’t].

    Article  CAS  PubMed  Google Scholar 

  12. Sloan JH, Ackermann BJ, O’Dell M, Bowsher RR, Dean RA, Konrad RJ. Development of a novel radioimmunoassay to detect autoantibodies to amyloid beta peptides in the presence of a cross-reactive therapeutic antibody. J Pharm Biomed Anal. 2011;56(5):1029–34 [Research Support, Non-U.S. Gov’t Validation Studies].

    Article  CAS  PubMed  Google Scholar 

  13. Sickert D, editor. AlphaLISA - a “no wash” high-throughput alternative to ELISA for PK, PD and immunogenicity measurement during drug development? European Bioanalytical Forum, 3rd Focus Meeting; 2012; Brussels, Belgium.

  14. Fraley KJ, Abberley L, Hottenstein CS, Ulicne JJ, Citerone DR, Szapacs ME. The Gyrolab immunoassay system: a platform for automated bioanalysis and rapid sample turnaround. Bioanalysis. 2013;5(14):1765–74 [Research Support, Non-U.S. Gov’t Validation Studies].

    Article  CAS  PubMed  Google Scholar 

  15. Liu R, Pillutla R, DeSilva B, Zhang YJ. Rapid development of multiple ‘fit-for-purpose’ assays on an automatic microfluidic system using a streamlined process in support of early biotherapeutics discovery programs. Bioanalysis. 2013;5(14):1751–63 [Research Support, Non-U.S. Gov’t].

    Article  CAS  PubMed  Google Scholar 

  16. Liu XF, Wang X, Weaver RJ, Calliste L, Xia C, He YJ, et al. Validation of a Gyrolab assay for quantification of rituximab in human serum. J Pharmacol Toxicol Methods. 2012;65(3):107–14.

    Article  CAS  PubMed  Google Scholar 

  17. Mora JR, Obenauer-Kutner L, Vimal PV. Application of the Gyrolab platform to ligand-binding assays: a user’s perspective. Bioanalysis. 2010;2(10):1711–5.

    Article  CAS  PubMed  Google Scholar 

  18. Patel V, Leach D, Hornberger M, Williams K, Shih J, Ma M, et al. Automating bioanalytical sample analysis through enhanced system integration. Bioanalysis. 2013;5(13):1649–59 [Research Support, Non-U.S. Gov’t].

    Article  CAS  PubMed  Google Scholar 

  19. St Ledger K, Agee SJ, Kasaian MT, Forlow SB, Durn BL, Minyard J, et al. Analytical validation of a highly sensitive microparticle-based immunoassay for the quantitation of IL-13 in human serum using the Erenna immunoassay system. J Immunol Methods. 2009;350(1–2):161–70 [Comparative Study].

    Article  CAS  PubMed  Google Scholar 

  20. Todd J, Freese B, Lu A, Held D, Morey J, Livingston R, et al. Ultrasensitive flow-based immunoassays using single-molecule counting. Clin Chem. 2007;53(11):1990–5.

    Article  CAS  PubMed  Google Scholar 

  21. Dyleski L J, A., et al., editor. Method development and validation of an alternative immunoassay platform for PK studies in a regulated environment. AAPS NBC; 2011; San Francisco, CA, USA.

  22. Tarasow TM, Penny L, Patwardhan A, Hamren S, McKenna MP, Urdea MS. Microfluidic strategies applied to biomarker discovery and validation for multivariate diagnostics. Bioanalysis. 2011;3(19):2233–51 [Research Support, Non-U.S. Gov’t Review].

    Article  CAS  PubMed  Google Scholar 

  23. Huber R, Eisenbraun J, Miletzki B, Adler M, Scheer R, Klein R, et al. Pharmacokinetics of natural mistletoe lectins after subcutaneous injection. Eur J Clin Pharmacol. 2010;66(9):889–97 [Clinical Trial, Phase I Research Support, Non-U.S. Gov’t].

    Article  CAS  PubMed  Google Scholar 

  24. Spriggs F, Aggarwal P, Deng S, Soderstrom C, Donovan C. Comparison of an antibody capture and a cell capture ligand-binding assay to quantify a monoclonal therapeutic in serum. Bioanalysis. 2011;3(6):605–11 [Comparative Study Evaluation Studies].

    Article  CAS  PubMed  Google Scholar 

  25. Dula M. ea, editor. Development and validation of a pharmacokinetic assay on the Gyrolab platform for use in phase II/III clinical studies. AAPS NBC; 2012; San Diego, CA, USA.

  26. Lee JW, Kelley M, King LE, Yang J, Salimi-Moosavi H, Tang MT, et al. Bioanalytical approaches to quantify “total” and “free” therapeutic antibodies and their targets: technical challenges and PK/PD applications over the course of drug development. Aaps J. 2011;13(1):99–110 [Review].

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  27. Lofgren JA, Dhandapani S, Pennucci JJ, Abbott CM, Mytych DT, Kaliyaperumal A, et al. Comparing ELISA and surface plasmon resonance for assessing clinical immunogenicity of panitumumab. J Immunol. 2007;178(11):7467–72 [Comparative Study Controlled Clinical Trial Validation Studies].

    Article  CAS  PubMed  Google Scholar 

Download references

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.

Author information

Authors and Affiliations

  1. Novartis Pharma AG, Novartis Institute for Biomedical Research, 144 Klybeckstrasse, 4052, Basel, Switzerland

    Sherri Dudal

  2. F. Hoffmann-La Roche Ltd, Grenzacherstrasse 124, Basel, 4070, Switzerland

    Sherri Dudal

  3. Pfizer Inc., Eastern Point Road, Groton, Connecticut, 06340, USA

    Daniel Baltrukonis

  4. Janssen, Research & Development, LLC, 145 King of Prussia Road, Radnor, Pennsylvania, 19087, USA

    Rebecca Crisino

  5. Biogen Idec, Cambridge, Massachusetts, 02142, USA

    M. Jaya Goyal

  6. Pfizer Inc., 1 Burtt Road, Andover, Massachusetts, 01834, USA

    Alison Joyce

  7. Gyros AB, Uppsala Science Park, 751 83, Uppsala, Sweden

    Karolina Österlund

  8. UCB Parma S.A, Avenue de l’Industrie, 1420, Braine-l’Alleud, Belgium

    John Smeraglia

  9. Toray Research Center, Inc., 10-1, Tebiro 6-chome, Kamakura-shi, Kanagawa, 248-0036, Japan

    Yoshitaka Taniguchi

  10. Genentech, 1 DNA Way, South San Francisco, California, 94080, USA

    Jihong Yang

Authors
  1. Sherri Dudal
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Daniel Baltrukonis
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Rebecca Crisino
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. M. Jaya Goyal
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Alison Joyce
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Karolina Österlund
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. John Smeraglia
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Yoshitaka Taniguchi
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. Jihong Yang
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Sherri Dudal.

Additional information

Guest Editors: Binodh DeSilva and Philip Timmerman

Rights and permissions

Reprints and permissions

About this article

Cite this article

Dudal, S., Baltrukonis, D., Crisino, R. et al. Assay Formats: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team. AAPS J 16, 194–205 (2014). https://doi.org/10.1208/s12248-013-9552-9

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1208/s12248-013-9552-9

KEY WORDS

Search

Navigation