Abstract
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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Nath, N., Godat, B., Flemming, R., Urh, M. (2022). Bioluminescent Bridging Immunoassay for Anti-Drug Antibody (ADA) Detection. In: Houen, G. (eds) Therapeutic Antibodies. Methods in Molecular Biology, vol 2313. Humana, New York, NY. https://doi.org/10.1007/978-1-0716-1450-1_20
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DOI: https://doi.org/10.1007/978-1-0716-1450-1_20
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Publisher Name: Humana, New York, NY
Print ISBN: 978-1-0716-1449-5
Online ISBN: 978-1-0716-1450-1
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