Case Study: Implementing Robust & Reproducible KILR® Ready-to-Use Bioassays from Screening to Lot Release: Applications for Measuring Direct Cytotoxic Cell Death
- Version:
- 21364
- Year:
- 2022
Therapeutic regulators require assay data on the impact of Fc effector-mediated function of antibodies during their development as therapeutics. The antibodies are required to demonstrate immune cell-mediated target cell killing via Antibody Dependent Cell-Mediated Cytotoxicity (ADCC) and/ or Antibody Dependent Cellular Phagocytosis (ADCP) rather than measuring a surrogate endpoint that exhibit antibody engagement of antigen on target cells. The Eurofins DiscoverX KILR® cytotoxicity assay platform specifically measures antibody-mediated killing of antigen-expressing target cells in co-culture with effector cells. This platform has been developed into a ready-to-use (RTU) bioassay format for several tumor models, including Raji and Daudi, for use in screening and lot-release applications. The KILR assay platform is robust and flexible and can be used for analyzing multiple mechanism-of-actions (MOAs), including ADCC, ADCP, complement-dependent cytotoxicity (CDC), and T-cell redirection. Abzena, a leading partner research organization that offers integrated discovery, development, and cGMP manufacturing services for biologics and bioconjugates, independently evaluated the bioassay format for KILR Raji target cell model in ADCC and ADCP assays to offer clients a robust platform for ranking and characterization studies. This case study demonstrates the ability of these bioassays to provide a quantitative readout for ADCC, ADCP, and CDC applications that produce large assay windows and excellent reproducibility (key aspects that help accelerate potency testing to QC lot release) when used with KILR CD16 Effector Cells