We also understand the importance of assessing your drug for immunogenicity, whether a therapeutic is endogenous or exogenous.
Anti-drug antibody (ADA) assays detect ADA binding to therapeutic protein products. A variety of factors can trigger ADAs: the drug product itself (molecular structure and post-translational modification, aggregates, formulation, impurities, etc.), the host (immune status, genetics), and the study design (route of drug administration, dosing, etc.). The consequences of ADA formation range from non-impactful to life-threatening. Further evaluation of neutralizing antibody (nAb) formation can help clarify the type and magnitude of the impact.
Our team develops and validates different assay formats (direct, indirect, bridging, etc.) based on your needs and on the characteristics of your drug product. We employ a tiered approach to ADA testing, with potentially positive samples detected during screening tier, and then evaluated further in confirmatory and titration tiers. Additional characterization, such as isotyping and neutralization testing, is then performed as required.