A Platform Approach To Assess Lack Of Monoclonal Antibody Effector Function Using An iQue® Screener PLUS

Sartorius have developed two platform approaches to asses a lack of Antibody-dependent cellular cytotoxicity (ADCC) or Antibody-dependent cellular phagocytosis (ADCP) MoAs of monoclonal antibodies using the iQue® Screener PLUS. The iQue® Screener PLUS achieves a faster assay throughput than traditional flow cytometers by sampling only microliters from each well and delivering an air-gap-delimited flow of samples to the detectors. This technology transforms a low throughput, time-consuming flow cytometry approach into a high throughput process.

An increasing number of therapeutic antibodies are designed not to induce Fc effector functions such as ADCC and ADCP. One such molecule is nivolumab that targets the immune checkpoint protein PD-1. It is required during the development of these molecules to demonstrate that IgG MoAs do not occur. The key to a well designed lack of effector function assay is the identification of a suitable positive control molecule. The PC demonstrates that each individual assay run is capable of inducing the MoA under assessment. The data presented here was obtained from development studies performed at Sartorius Glasgow site.