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Cell-based assays are used in clinical studies to assess many functional and biochemical effects, including: antibody dependent (ADCC) and complement dependent (CDC) cytoxicity, enzyme activity, cytokine secretion, and apoptosis.

Cell-based Assays (Immune Function & NAb)

The ability to deliver customized therapy to specific targets, at the cellular level, is an exciting development in the treatment of human disease. However, many therapeutic agents, especially biologics, can be immunogenic and have the potential to induce an anti-drug antibody (ADA) response reducing therapeutic efficacy. 

Cell-based assays, using technologies like flow cytometry and ELISpot, are frequently an important part of the FDA approval process for biopharmaceuticals. Our experts can help you determine the best way to assess the immunogenicity of your drug candidate.

• Flow cytometry (FC) applications involve immunogenicity assessment and immune response characterization. The specific assays include immunophenotyping, receptor occupancy, cytokine production and other functional studies
• The enzyme-linked immune absorbent spot (ELISPOT) assay measures cellular immune response. Specifically, the detection of antigen-specific T cells by visualization of cytokine secretion, following in vitro stimulation with antigen. The assay can be more sensitive than enzyme-linked immunosorbent assay (ELISA), and does not require in vitro expansion of specific T cells before testing.

Our clients rely on us for a comprehensive array of functional assays (ADCC & CDC), as well as neutralizing antibody assays (NAb) to characterize neutralizing activity of ADAs, due to their potential impact on pharmacokinetics, pharmacodynamics, safety, and efficacy