Over the last decades, the interest in therapeutic monoclonal antibody (mAb) development has led to a need for sensitive, reliable, and biologically relevant bioassays for measuring Fc-effector activity. Traditional methods closely resemble what happens in the body but have drawbacks. Reporter gene assays can overcome some of these drawbacks but have other challenges that must be overcome.
Classical methods typically use effector cells, either as peripheral blood mononuclear cells (PBMCs) or purified NK cells derived from individual human donors. These methods more closely resemble what happens in the body but are labor-intensive and have a high level of inherent variability due to the use of primary human cells from different donors.