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Ligand Binding Assays in the 21st Century Laboratory: Platforms

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  • Theme: Ligand Binding Assays in the 21st Century Laboratory
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Abbreviations

ADA:

Anti-drug antibody

CFR:

Code of federal regulations

LBA:

Ligand binding assay

PK:

Pharmacokinetics

REFERENCES

  1. Li J, Schantz A, Schwegler M, Shankar G. Detection of low-affinity anti-drug antibodies and improved drug tolerance in immunogenicity testing by Octet(R) biolayer interferometry. J Pharm Biomed Anal. 2011;54:286–94.

    Article  PubMed  CAS  Google Scholar 

  2. Liang M, Klakamp SL, Funelas C, Lu H, Lam B, Heri C, et al. Detection of high- and low-affinity antibodies against a human monoclonal antibody using various technology platforms. Assay Drug Dev Technol. 2007;5(5):655–62.

    Article  PubMed  CAS  Google Scholar 

  3. Mikulskis A, Yeung D, Subramanyam M, Amaravadi L. Solution ELISA as a platform of choice for development of robust, drug tolerant immunogenicity assays in support of drug development. J Immunol Methods. 2011;365:38–49.

    Article  PubMed  CAS  Google Scholar 

  4. Pan J, Small T, Qin D, Li S, Wang L, Chen D, et al. Comparison of the NIDS(R) rapid assay with ELISA methods in immunogenicity testing of two biotherapeutics. J Pharmacol Toxicol Methods. 2011;63:150–9.

    Article  PubMed  CAS  Google Scholar 

  5. 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.

    Article  PubMed  CAS  Google Scholar 

  6. Wu X, Glickman JF, Bowen BR, Sills MA. Comparison of assay technologies for a nuclear receptor assay screen reveals differences in the sets of identified functional antagonists. J Biomol Screen. 2003;8:381.

    Article  PubMed  CAS  Google Scholar 

  7. Magana I, Thway T, Soto M, Ponce M, Salyers K, Ma M. A combined bioanalytical-serial sampling approach to support large molecule discovery studies in mice. American Association of Pharmaceutical Scientists Annual Meeting. Washington D.C. 2011.

  8. Roussis M, Beard E, Prakash K, Strouse R, Washabaugh M. High throughput process-related impurity testing using a Gyrolab(TM) workstation. Well-characterized biologic products. Washington D.C. 2011.

  9. Chappell J, Raha N, Durham R, Sharma V, Lawrence J, Tew Z, et al. Validation of alzheimer biomarkers assays using various analytical techniques in CSF and plasma. American Association of Pharmaceutical Scientists Annual Meeting. Atlanta, Georgia. 2008.

  10. Gibbs J. Selecting the detection system—colorimetric, fluorescent, luminescent methods. Corning Life Sciences ELISA Technical Bulletin 2001:14.

  11. Adler M, Schulz S, Spengler M. Cytokine quantification in drug development: A comparison of sensitive immunoassay platforms. Chimera Biotec GmbH, Dortmund Germany. http://www.chimera-biotec.de/data/pdf/Cytokine_Quant_Comp_Final.pdf. Report retreived on July 22, 2011.

  12. 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):16.

    Article  Google Scholar 

  13. Shankar GDV, Amaravadi L, Barrett YC, Bowsher R, Finco-Kent D, et al. Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products. J Pharm Biomed Anal. 2008;48(5):14.

    Article  Google Scholar 

  14. Lee JW, Devanarayan V, Barrett YC, Weiner R, Allinson J, Fountain S, et al. Fit-for-purpose method development and validation for successful biomarker measurement. Pharm Res. 2006;22(2):17.

    Google Scholar 

  15. ICH. ICH-Q2(R1): Validation of analytical procedures: text and methodology. International Conference on Harmonization 1995:9.

  16. Food Drug and Cosmetics Act. 21CFR32029. United States of America 2010.

  17. Mire-Sluis AR, Barrett YC, Devanarayan V, Koren E, Liu H, Maia M, et al. Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products. J Immunol Methods. 2004;289:16.

    Article  Google Scholar 

  18. Entzeroth M, Flotow H, Condron P. Overview of high-throughput screening. New York: Wiley; 2001.

    Google Scholar 

  19. Ullman EF, Kirakossian H, Switchenko AC, Ishkanian J, Ericson M, Wartchow CA, et al. Luminescent oxygen channeling assay (LOCI): sensitive, broadly applicable homogeneous immunoassay method. Clin Chem. 1996;42(9):1518–26.

    PubMed  CAS  Google Scholar 

  20. 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):12.

    Article  Google Scholar 

  21. Hack C, Groot ED, Felt-Bersma R, Nuijens J, Schijndel RSV, Eerenberg-Belmer A, et al. Increased plasma levels of interleukin-6 in sepsis. Blood. 1989;75(5):1704–11.

    Google Scholar 

  22. 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. 2007;178:7467–72.

    CAS  Google Scholar 

  23. Sickert D, Kroeger K, Zickler C, Chokote E, Winkler B, Grenet J-M, et al. Improvement of drug tolerance in immunogenicity testing by acid treatment on biacore drug target interference. J Immunol Methods. 2008;334:7.

    Article  Google Scholar 

  24. Patton A, Mullenix MC, Swanson SJ, Koren E. An acid dissociation bridging ELISA for detection of antibodies directed against therapeutic proteins in the presence of antigen. J Immunol Methods. 2005;304(1–2):189–95.

    Article  PubMed  CAS  Google Scholar 

  25. Ray CA, Zhou L, Tsoi J, Uy L, Gu J, Malella J, et al. A strategy for improving comparability across sites for ligand binding assays measuring therapeutic proteins. J Pharmacol Biomed Anal. 2010;53:6.

    Article  Google Scholar 

  26. Wild D, editor. The immunoassay handbook. 3rd ed. Kidlington: Elsevier Ltd.; 2005. p. 364–70.

    Google Scholar 

  27. Kricka LJ, Wild D. The immunoassay handbook. 3rd ed. Amsterdam: Elsevier Science; 2005. p. 192–209.

    Google Scholar 

  28. Yohrling J. Ligand-binding assays: risk of using a platform supported by a single vendor. Bioanalysis. 2009;1(3):8.

    Article  Google Scholar 

  29. Anderson J, Narasimhan R. Assessing project implementation risk: a methodological approach. Manag Sci. 1979;25(6):10.

    Article  Google Scholar 

  30. Covello VT. Decision analysis and risk management decision making: issues and methods. Risk Anal. 1987;7(2):131–9.

    Article  PubMed  CAS  Google Scholar 

  31. Klinke A, Renn O. A new approach to risk evaluation and management: risk-based, precaution-based, and discourse-based strategies. Risk Anal. 2002;22(6):24.

    Article  Google Scholar 

  32. Macmillan IC, Siegel R, Narasimha PNS. Criteria used by venture capitalists to evaluate new venture proposals. J Bus Ventur. 1985;1(1):119–28.

    Article  Google Scholar 

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Author information

Authors and Affiliations

  1. Department of Pharmacokinetics, Dynamics, and Metabolism, Pfizer, Inc., 1 Burtt Road, MS G2002, Andover, Massachusetts, 01810, USA

    Franklin P. Spriggs

  2. Department of Medical Sciences–Clinical Immunology, Amgen, Inc., 1 Amgen Center Drive, Thousand Oaks, California, 91320, USA

    Zhandong Don Zhong

  3. Department of Bioanalytical Operations, BioAgilytix Labs, 2300 Englert Drive, Suites G-J, Research Triangle Park, North Carolina, 27713, USA

    Afshin Safavi

  4. Department of Translational Sciences, Biogen Idec Inc., 14 Cambridge Center, Cambridge, Massachussets, 01748, USA

    Darshana Jani

  5. Department of Analytical Research and Development, Celgene Corp, 86 Morris Ave, Summit, New Jersey, 07901, USA

    Narasaiah Dontha

  6. Department of BioResearch Marketing, Molecular Devices, LLC, 1311 Orleans Dr, Sunnyvale, California, 94089, USA

    Anita Kant

  7. Department of Scientific Support, Meso-Scale Discovery, 9238 Gaither Road, Gaithersburg, Maryland, 20877, USA

    Jenny Ly

  8. Department of Project Services, WIL Research Company, LLC, Skokie, Illinois, 60077, USA

    Lia Brilando

  9. Department of Field Applications, Gyros AB, Uppsala Science Park, SE-751 83, Uppsala, Sweden

    Karolina Österlund

  10. Department of Bio-discovery, Perkin Elmer Biosignal, Inc., 1744 Rue William, Montreal, Canada, QC H3J 1R4

    Nathalie Rouleau & Martin Boissonneault

  11. Department of Bioanalytical Research and Development, Genentech, 1 DNA Way, South San Francisco, California, 94080, USA

    Saloumeh Kadkhodayan Fischer

  12. Department of Pharmacokinetics, Dynamics, and Metabolism, Pfizer, Inc., 10628 Science Center Drive, San Diego, California, 92122, USA

    Chad Ray

Authors
  1. Franklin P. Spriggs
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  2. Zhandong Don Zhong
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  3. Afshin Safavi
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  4. Darshana Jani
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  5. Narasaiah Dontha
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  6. Anita Kant
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  7. Jenny Ly
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  8. Lia Brilando
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  9. Karolina Österlund
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  10. Nathalie Rouleau
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  11. Saloumeh Kadkhodayan Fischer
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  12. Martin Boissonneault
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  13. Chad Ray
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Corresponding author

Correspondence to Franklin P. Spriggs.

Additional information

Guest Editors: William Nowatzke, Ago Ahene and Chad Ray

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Spriggs, F.P., Zhong, Z.D., Safavi, A. et al. Ligand Binding Assays in the 21st Century Laboratory: Platforms. AAPS J 14, 113–118 (2012). https://doi.org/10.1208/s12248-012-9321-1

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  • DOI: https://doi.org/10.1208/s12248-012-9321-1

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