Promega Corporation is pleased to announce that The Scientist has named the ADCC Reporter Bioassay to its 2013 Top 10 Innovations. The ADCC Reporter Bioassay is a surrogate assay for evaluating antibody-dependent, cell-mediated cytotoxicity (ADCC) of therapeutic mAbs, and it exhibits greatly reduced variability and is easier to perform than classic ADCC assays. ADCC is the primary mechanism of action of many mAb therapeutic drugs.
This innovation is transforming biologics drug development by allowing the biotech industry to more easily and reproducibly characterize mAb therapeutic drugs during manufacturing and lot release, as well as in earlier drug development stages such as clonal selection of antibodies.
The new ADCC Reporter Bioassay is available in kits with cells provided in frozen, thaw-and-use format, plus components to perform a homogeneous bioassay in a single day. The product replaces variable natural killer effector cells, typically primary in origin, with engineered effector cells that use a reporter gene readout approach. The effector cells, and control target cells, are ready to use without need for cell culture propagation.
The assay possesses all of the hallmarks of an optimal bioassay - excellent linearity, specificity, repeatability, precision and accuracy - and therefore can be used for potency lot release, stability indicating and antibody screening applications. Furthermore, the bioassay is sensitive enough to assess the impact of post-translational modifications, such as glycosylation and fucosylation, an area of intense exploration, on the potency of mAbs.