Emerging Technologies and Generic Assays for the Detection of Anti-Drug Antibodies
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...
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| Main Authors: | , , , |
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| Format: | Article |
| Language: | English |
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Wiley
2016-01-01
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| Series: | Journal of Immunology Research |
| Online Access: | http://dx.doi.org/10.1155/2016/6262383 |
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| author | Michael A. Partridge Shobha Purushothama Chinnasamy Elango Yanmei Lu |
| author_facet | Michael A. Partridge Shobha Purushothama Chinnasamy Elango Yanmei Lu |
| author_sort | Michael A. Partridge |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-aca4911d9c024008969ed88b3c85fe2e |
| institution | Kabale University |
| issn | 2314-8861 2314-7156 |
| language | English |
| publishDate | 2016-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of Immunology Research |
| spelling | doaj-art-aca4911d9c024008969ed88b3c85fe2e2025-02-03T01:00:36ZengWileyJournal of Immunology Research2314-88612314-71562016-01-01201610.1155/2016/62623836262383Emerging Technologies and Generic Assays for the Detection of Anti-Drug AntibodiesMichael A. Partridge0Shobha Purushothama1Chinnasamy Elango2Yanmei Lu3Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY 10591, USAUCB Pharma, Slough, Berkshire SL1 14EN, UKRegeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY 10591, USADepartment of Biochemical & Cellular Pharmacology, Genentech Inc., South San Francisco, CA 94080, USAAnti-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.http://dx.doi.org/10.1155/2016/6262383 |
| spellingShingle | Michael A. Partridge Shobha Purushothama Chinnasamy Elango Yanmei Lu Emerging Technologies and Generic Assays for the Detection of Anti-Drug Antibodies Journal of Immunology Research |
| title | Emerging Technologies and Generic Assays for the Detection of Anti-Drug Antibodies |
| title_full | Emerging Technologies and Generic Assays for the Detection of Anti-Drug Antibodies |
| title_fullStr | Emerging Technologies and Generic Assays for the Detection of Anti-Drug Antibodies |
| title_full_unstemmed | Emerging Technologies and Generic Assays for the Detection of Anti-Drug Antibodies |
| title_short | Emerging Technologies and Generic Assays for the Detection of Anti-Drug Antibodies |
| title_sort | emerging technologies and generic assays for the detection of anti drug antibodies |
| url | http://dx.doi.org/10.1155/2016/6262383 |
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