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The clinical activity of numerous monoclonal antibodies is at least partly mediated through antibody-dependent cell-mediated cytotoxicity (ADCC). Traditional methods of quantifying ADCC activity are labor intensive and have high levels of inherent variability. Engineered effector cell lines have significantly lower variation between assays. However, there is a need for a controlled set of target cells to determine differences in ADCC activity with high specificity and precision.

Here, we present a comparative case study using a novel ADCC effector cell line expressing a reporter gene to compare a new target cell line overexpressing a constant high level of a specific antigen and a homologous wild-type target cell line.

In this poster, we present a method for the quantification of ADCC activity using a novel engineered effector cell line. In addition, novel target cells have been developed that express a constant high level of a specific antigen, HER2, as well as control target cells which allow differences in ADCC activity to be determined with precision and a high degree of specificity.

We tested the iLite® ADCC HER2 assay for the most critical parameters included in clinical bioassay characterization: Serum tolerance, cut-point determination, NAb assay sensitivity using different antibodies and drug tolerance evaluation at high NAb level.

In this poster, we present a method for quantification of ADCC activity based on the use of novel engineered effector cells carrying a reporter gene. In addition, novel target cells have been developed that express a constant high level of the specific antigen as well as the homologous control target cells which allows differences in ADCC activity to be determined with precision and a high degree of specificity.

Results are presented for the quantification of ADCC activity of Trastuzumab and Cetuximab in the presence of normal human serum.

Here we present a method for quantification of ADCC activity based on reporter gene-carrying engineered effector cells. iLite^® ADCC effector cells were assayed together with HER2 positive and negative iLite target cells and Trastuzumab. In addition, Infliximab ADCC activity was quantified with mTNF(+) and (-) target cells.