Bioluminescent Bridging Immunoassay for Anti-Drug Antibody (ADA) Detection
In: Therapeutic Antibodies ISBN: 9781071614495; (2021-09-04)
Online
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Zugriff:
Any immune reaction to therapeutic antibodies will impact the drug efficacy and can have serious consequences for patient safety. Therefore, detection and reporting of anti-drug antibodies (ADA) during clinical trials is required by regulatory agencies during drug approval process. We have developed a bioluminescent bridging immunoassay for ADA detection, which uses an extremely bright NanoLuc enzyme as a reporter. The assay is sensitive with a wide dynamic range and meets the FDA drug tolerance guideline of detecting 100 ng/ml of ADA in the presence of 500-fold excess of free drug. We describe detailed protocols for development of ADA assays using therapeutic Trastuzumab as a model drug and an anti-Trastuzumab antibody as an example of immune response.
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Bioluminescent Bridging Immunoassay for Anti-Drug Antibody (ADA) Detection
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Autor/in / Beteiligte Person: | Urh, Marjeta ; Nath, Nidhi ; Godat, Becky ; Flemming, Rod |
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Quelle: | Therapeutic Antibodies ISBN: 9781071614495; (2021-09-04) |
Veröffentlichung: | Springer US, 2021 |
Medientyp: | unknown |
ISBN: | 978-1-0716-1449-5 (print) |
DOI: | 10.1007/978-1-0716-1450-1_20 |
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