Assay Formats: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team
- 886 Downloads
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 WORDSassay format biotherapeutic large molecule platform technology
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.
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.
- 2.US Department of Health and Human Services, Food and Drug administration, CDER, CVM. Guidance for Industry, Bioanalytical Method Validation, 2001.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].PubMedCentralPubMedCrossRefGoogle Scholar
- 7.European Medicines Agency. Guideline on Bioanalytical Method Validation, 2009.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].PubMedCrossRefGoogle 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].PubMedCrossRefGoogle 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.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].PubMedCrossRefGoogle 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].PubMedCrossRefGoogle 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.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.Google Scholar
- 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].PubMedCentralPubMedCrossRefGoogle 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].PubMedCrossRefGoogle Scholar