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Emerging Technologies to Increase Ligand Binding Assay Sensitivity

  • Review Article
  • Theme: Emerging Technologies in the BioAnalytical Space Applied to Large Molecule Determinations
  • Published:
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Abstract

Ligand binding assays (LBAs) have been the method of choice for protein analyte measurements for more than four decades. Over the years, LBA methods have improved in sensitivity and achieved larger dynamic ranges by using alternative detection systems and new technologies. As a consequence, the landscape and application of immunoassay platforms has changed dramatically. The introduction of bead-based methods, coupled with single molecule detection standardization and the ability to amplify assay signals, has improved the sensitivity of many immunoassays, in some cases by several logs of magnitude. Three promising immunoassay platforms are described in this article: Single Molecule Counting (SMC™) from Singulex Inc, Single Molecule Arrays (Simoa™) from Quanterix Corporation, and Immuno-PCR (Imperacer®) from Chimera Biotec GmbH. These platforms have the potential to significantly improve immunoassay sensitivity and thereby address the bioanalytical needs and challenges faced during biopharmaceutical drug development.

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Author information

Authors and Affiliations

  1. Department of BioAnalytical Sciences, Genentech, 1 DNA Way, South San Francisco, California, 94080-4990, USA

    Saloumeh K. Fischer

  2. Pharmacokinetics, Dynamics and Metabolism, Pfizer, Inc., 1 Burtt Road, Andover, Massachusetts, 01810, USA

    Alison Joyce

  3. Chimera Biotec GmbH, Emil-Figge Str. 76a, 44227, Dortmund, Germany

    Mark Spengler

  4. Biologics Clinical Pharmacology, Biotechnology Center of Excellence, Janssen R&D LLC, 1400 McKean Road, Spring House, Pennsylvania, 19477, USA

    Tong-Yuan Yang

  5. Clinical Immunology, Amgen Inc., One Amgen Center Drive, Thousand Oaks, California, 91320, USA

    Yao Zhuang

  6. Novo Nordisk A/S, Novo Nordisk Park, DK-2760, Måløv, Denmark

    Marianne Scheel Fjording

  7. Translational Sciences and Technology, Biogen Idec, Inc., 14 Cambridge Center, Cambridge, Massachusetts, 02142, USA

    Alvydas Mikulskis

Authors
  1. Saloumeh K. Fischer
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  2. Alison Joyce
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  3. Mark Spengler
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  4. Tong-Yuan Yang
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  5. Yao Zhuang
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  7. Alvydas Mikulskis
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Corresponding author

Correspondence to Saloumeh K. Fischer.

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Guest editors: Johanna Mora and Binodh DeSilva

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Fischer, S.K., Joyce, A., Spengler, M. et al. Emerging Technologies to Increase Ligand Binding Assay Sensitivity. AAPS J 17, 93–101 (2015). https://doi.org/10.1208/s12248-014-9682-8

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  • DOI: https://doi.org/10.1208/s12248-014-9682-8

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