Biological drug products often elicit an immune response in patients that can lead to clinical consequences of the presence of anti-drug antibodies (ADA) varying from mild to serious adverse events. Therefore, the presence of ADA is a major safety and efficacy concern and should be evaluated and correlated with any pharmacological or toxicological observations.
The development of rapid and sensitive assay platforms for ADA detection is an essential step of the drug development process. In this application note, we demonstrate that the AlphaLISA® mix-and-read homogeneous assay permits the sensitive detection of ADA.