Table of Contents Author Guidelines Submit a Manuscript
Journal of Immunology Research
Volume 2016 (2016), Article ID 6262383, 6 pages
http://dx.doi.org/10.1155/2016/6262383
Review Article

Emerging Technologies and Generic Assays for the Detection of Anti-Drug Antibodies

1Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY 10591, USA
2UCB Pharma, Slough, Berkshire SL1 14EN, UK
3Department of Biochemical & Cellular Pharmacology, Genentech Inc., South San Francisco, CA 94080, USA

Received 20 April 2016; Revised 26 May 2016; Accepted 9 June 2016

Academic Editor: Eyad Elkord

Copyright © 2016 Michael A. Partridge et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Anti-drug antibodies induced by biologic therapeutics often impact drug pharmacokinetics, pharmacodynamics response, clinical efficacy, and patient safety. It is critical to assess the immunogenicity risk of potential biotherapeutics in producing neutralizing and nonneutralizing anti-drug antibodies, especially in clinical phases of drug development. Different assay methodologies have been used to detect all anti-drug antibodies, including ELISA, radioimmunoassay, surface plasmon resonance, and electrochemiluminescence-based technologies. The most commonly used method is a bridging assay, performed in an ELISA or on the Meso Scale Discovery platform. In this report, we aim to review the emerging new assay technologies that can complement or address challenges associated with the bridging assay format in screening and confirmation of ADAs. We also summarize generic anti-drug antibody assays that do not require drug-specific reagents for nonclinical studies. These generic assays significantly reduce assay development efforts and, therefore, shorten the assay readiness timeline.