Preclinical immunogenicity studies to clinical trials

Anti-drug antibodies (ADA) / Neutralizing antibodies (NAb)

The extend of anti-drug-antibody formation can be dependent on the individual patient, type of administration or the biological molecule itself. Thus, an understanding of potential immune responses is crucial.

High drug concentrations, due to high-level dosing or long half-life, can complicate ADA detection – especially in ADA-bridging assays, where labeled drug conjugates and free drug are competing for ADAs. In such cases, breaking up drug-ADA-complexes can optimize drug tolerance.

Development of valid and selective assays to measure ADA responses is a key aspect of therapeutic protein product development. An assessment of immunogenicity is dependent on key operating parameters of the assays: sensitivity (detection of clinically relevant levels of ADAs), specificity (interference of on-board drug, matrix, soluble drug target)

Our team is highly experienced in the development of immunoassays that ensure immunogenicity testing with extreme drug and target tolerance.