Promega Corporation has announced the introduction of a novel bioluminescent assay for the quantification of Fc effector function of antibody-based molecules in the development and manufacture of biologic drugs.
The assay is ADCC mechanism of action (MOA)-based and features frozen, thaw-and-use effector cells, and optimised reagents and protocol to perform a reporter-based ADCC bioassay in a single day. The ADCC Reporter Bioassay correlates with classic cytotoxic ADCC assays and is a suitable replacement for these highly variable assays.
Antibody-dependent cell-mediated cytotoxicity (ADCC) is the main MOA of antibodies through which virus-infected or other diseased cells are targeted for destruction by components of the cell-mediated immune system, such as natural killer cells.
The ADCC Reporter Bioassay uses an alternative readout at an earlier point in the ADCC MOA pathway: the activation of gene transcription through the NFAT (nuclear factor of activated T-cells) pathway in the effector cell. In addition, the bioassay uses engineered Jurkat cells stably expressing the FcγRIIIa receptor V158 (high affinity) variant and an NFAT response element driving expression of firefly luciferase.
The novel bioassay is linear, accurate, precise and stability indicating. It shows good linear correlation between levels of glycosylation or fucosylation and ADCC activity. All these features indicate the assay is suitable for use across biologic drug development programs.
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