Promega Launches Novel ADCC Reporter Bioassay for Biologics

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 optimized 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 cumbersome and 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 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.

Following extensive in-house studies and a successful alpha trial program, the ADCC Reporter Bioassay is now being adopted by global biologics companies as well as being offered as a service by Charles River Laboratories. The novel bioassay is linear, accurate, precise and stability indicating. Moreover, the bioassay shows good linear correlation between levels of glycosylation or fucosylation and ADCC activity. All of these features indicate the assay is suitable for use across biologic drug development programs.