Evaluation of potential biotin interference in immunogenicity testing.

ABSTRACT

Aim: One-step bridging assays typically used for immunogenicity testing may be challenged by biotin interference (BI) caused by widely available dietary supplementation or medically prescribed high-dose therapies. We investigated BI in two one-step antidrug antibody assays. Results: Both assays showed biotin-related interference, with the peptide-based assay being less affected than the antibody-based assay. BI was reduced by minimum required dilution adaption from 10 to 1% and eliminated by a depletion-based sample pretreatment. Conclusion: Increased biotin levels have the potential to interfere with immunogenicity testing methods that use biotin technology. Since the extent of interference differs from assay to assay, assessment during development phase is recommended. Minimum required dilution adjustment or sample pretreatment are options to reduce or eliminate BI.