Abstract
Background: The development of immunogenicity assays for clinical drug candidates targeting soluble proteins is challenging when the soluble target might produce either false-positive or false-negative signals in bridging anti-drug antibody screening assays. A generic soluble target removal protocol that uses a pH-dependent depletion was evaluated. Results: An anti-drug antibody bridging assay with a pH-dependent soluble target depletion step was successfully developed. Endogenous target levels of ∼600nM could be depleted below 8pM. The assay was highly drug tolerant and met regulatory requirements. Conclusion: A reagent-independent target depletion protocol can be used for immunogenicity testing in the presence of a soluble target. The generic protocol circumvents common depletion or masking protocols.
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