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 100ng/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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