Hi Everyone,
I'm seeking some input on expectations for neutralizing antibody (NAb) assays in antibody–drug conjugate (ADC) programs based on your experiences.
1️⃣ For ADCs, is a cell-based NAb assay considered a requirement, or would a competitive ligand-binding assay (LBA) be acceptable to demonstrate neutralizing of binding for the antibody component?
2️⃣ (Not specific for ADCs) For studies conducted or submitted in China, what has been your experience regarding NAb assay expectations? Specifically, is there an expectation for a cell-based format, or have competitive LBAs been accepted by Chinese regulatory authorities?
Any insights you can share would be greatly appreciated!
Many thanks,
Rob
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Robert Nelson
Scientific Officer, Executive Director
BioAgilytix Laboratories
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer or other entities to which I am affiliated.
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