Immunogenicity & Bioassay Summit 2026

How can drug and target interference affect ADA assay performance?

Drug and target interference can reduce an assay’s ability to reliably detect anti-drug antibodies and may complicate interpretation of immunogenicity results. The appropriate strategy depends on factors such as therapeutic concentration, target biology, assay format, and the expected characteristics of the immune response. Evaluating these risks early can help guide assay design and determine whether additional approaches are needed to improve drug or target tolerance.

What should be considered when developing immunogenicity assays for peptide therapeutics?

Peptide therapeutics can present distinct immunogenicity challenges related to their size, structure, endogenous counterparts, therapeutic concentrations, and expected antibody responses. Assay development should consider these characteristics alongside sensitivity, specificity, drug tolerance, and the clinical context in which the resulting immunogenicity data will be interpreted.

When should drug tolerance be evaluated during ADA assay development?

Drug tolerance should be considered early in assay development, particularly when circulating therapeutic concentrations could interfere with ADA detection. Understanding expected drug exposure and the assay’s intended application can help establish appropriate tolerance requirements and inform whether sample pretreatment or alternative assay approaches should be evaluated.

How do you determine the appropriate approach for a neutralizing antibody assay?

The appropriate NAb assay strategy depends on the therapeutic's mechanism of action, biological activity, target, and stage of development. Cell-based assays may provide a biologically relevant assessment of neutralizing activity, while other approaches may be appropriate depending on the molecule and program. The assay format should ultimately be selected based on scientific rationale, regulatory expectations, and the intended use of the data.

How should immunogenicity strategy evolve as a therapeutic moves through development?

Immunogenicity assessment should evolve with the program rather than remain static. Early studies can help characterize potential immune responses and assay performance, while later clinical development may require increasingly robust, validated methods and an integrated assessment of ADA, NAb, PK, safety, efficacy, and relevant biomarker data.

Why is it important to evaluate immunogenicity data alongside PK and biomarker results?

ADA results alone do not always explain the clinical significance of an immune response. Evaluating immunogenicity alongside PK, biomarkers, safety, and efficacy can provide greater context for determining whether an immune response is affecting therapeutic exposure, biological activity, or clinical outcomes.