Immunology overlaps many therapeutic areas, and immunological processes in the body can often impact the pharmacokinetics of a therapeutic agents.
Many targeted immunotherapies and anticancer agents 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..
“Whether assisting clients in achieving compliance with regulatory requirements for assessing immunogenicity, hypersensitivity and adverse immune stimulation or in evaluating testing to aid with subject stratification, our extensive menu of more than two thousand assays distinguishes Viracor as your ideal partner.
Employing advanced technology platforms, together with our live cell handling capabilities, our experienced scientific staff has developed and supported clinical trials testing with a wide variety of assays including ADA, NAb, TAB, Immunogenicity and T-cell functional assays