Drug developers continue to be challenged by the development and application of immunogenicity assays. The FDA has advocated a more stringent approach for cut point setting and assay validation creating further difficulties. Questions arise about when neutralizing antibody assays should be applied and which type is the best.
There may also be challenges around drug and target interference, as well as how to address pre-existing antibodies, and data interpretation.
Many targeted anticancer agents and immunotherapies are biological drugs, that may trigger immune responses leading to the formation of antidrug antibodies (ADAs). ADAs are directed against immunogenic parts of the drug and may affect efficacy and safety. In order to determine this relevance, the possible effects of ADAs on pharmacokinetics, efficacy, and safety parameters need to be investigated. We understand the challenges in ADA detection and are skilled at developing, validating, standardizing, and transferring these assays.
Cell-based Assays (Functional & NAb)
The ability to deliver customized therapy to specific targets, at the cellular level, is an exciting development in the treatment of human disease. And cell-based assays are frequently an important part of the FDA approval process for biopharmaceuticals.
Our clients rely on us for a variety of functional assays (ADCC & CDC), as well as neutralizing antibody assays (NAb).