High levels of pre-existing antibodies can require a different approach to immunogenicity testing.

Traditional anti-drug antibody (ADA) screening strategies may not be suitable for therapeutics with a high prevalence of pre-existing antibodies. This poster presents an alternative immunogenicity testing strategy that replaces conventional screening with confirmatory analysis, incorporating domain specificity testing and customized validation approaches to support reliable immune response assessments.

Key highlights include:

• An alternative immunogenicity testing strategy for therapeutics with high pre-existing antibody prevalence
• Use of confirmatory analysis in place of traditional screening assays
• Integration of domain specificity testing to improve result interpretation
• Customized assay validation approaches to support reliable ADA assessments
• Practical considerations for immunogenicity testing in highly reactive patient populations

As therapeutic modalities continue to evolve, immunogenicity testing strategies must adapt to increasingly complex biological challenges. See how alternative assay designs can help overcome the limitations of traditional screening approaches while supporting robust, fit-for-purpose immunogenicity assessments.