Antidrug antibody (ADA) assessment may be challenged in studies that involve the administration of high doses of biotherapeutics and/or with long half-lives. In such cases, ADA assays with optimized drug tolerance are desired. We evaluated the use of MgCl to develop high ionic strength dissociation assays in two investigational examples (bridging enzyme-linked immunosorbent ADA assays) to attain high drug tolerance while maintaining best possible structural integrity of ADAs. Both ADA-bridging assays treated with MgCl showed improved drug tolerance and higher signal-to-blank values compared with overnight incubation or acid treatment. The use of MgCl treatment in ADA-bridging assays provides a sensitive, drug tolerant and easy-to-use alternative in cases where acid dissociation is not possible or unwanted.
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| http://dx.doi.org/10.4155/bio-2020-0138 | DOI Listing |
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