TSKgel FcR-IIIA-NPR is based on a recombinant Fc gamma IIIa receptor ligand immobilized on a non-porous polymer particle. It allows fast assessment of biologic activity of monoclonal antibodies.
Fc gamma IIIa receptor plays a key role in antibody-dependent cell mediated cytotoxicity (ADCC) which is a crucial mechanism of action of anti-tumor mAbs. These Fc-mediated effector functions are known to be related to Fc-glycans of antibodies. Hence, separation patterns of therapeutic antibodies on TSKgel FcR-IIIA-NPR can be correlated to both glycan pattern and the ADCC activity of immunoglobulins. Early eluting peaks of TSKgel FcR-IIIA-NPR represent glycoforms with low ADCC activity while late eluting peaks represent glycoforms with high ADCC activity.
The rapid thirty-minute separation allows the analysis of large numbers of mAb samples to gain valuable first information on the distribution of glycoforms and expected ADCC activity. This fast and efficient method can be applied to purified samples and supernatant alike and can therefore be used in many phases of development and production such as cell line screening in early R&D, biosimilar/originator comparison, upstream development and optimization, monitoring of glycoengineering, or lot-to-lot comparison in QC.