Bioluminescent Bridging Immunoassay for Anti-Drug Antibody (ADA) Detection.

Autor:	Nath N; Promega Corporation, Madison, WI, USA. nidhi.nath@promega.com., Godat B; Promega Corporation, Madison, WI, USA., Flemming R; Promega Corporation, Madison, WI, USA., Urh M; Promega Corporation, Madison, WI, USA.
Jazyk:	angličtina
Zdroj:	Methods in molecular biology (Clifton, N.J.) [Methods Mol Biol] 2022; Vol. 2313, pp. 313-322.
DOI:	10.1007/978-1-0716-1450-1_20
Abstrakt:	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. (© 2022. Springer Science+Business Media, LLC, part of Springer Nature.)
Databáze:	MEDLINE
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