Therapeutic Fc Characterization

Therapeutic antibody development and production are significant components of the biopharmaceutical sector and have had a significant positive impact on public health. To be clinically effective, therapeutic antibodies must perform two different types of functions: (i) target-specific binding via variable domains, and (ii) immune-mediated effector function via interaction of Fc (crystalllizable fragment) domains with cell receptors and complement proteins. By attaching to Fc-receptors (FcR) on immune cells or repairing complement, antibodies and antibody-based therapies have the potential to enhance immune function. The Fc region of the mAb must be described for IND and BLA submissions in accordance with the ICH Q6B and EMA mAb criteria. Therapeutic Fc characterisation was developed to promote the development of biobetter or biosimilar treatments after focusing on the development of antibody therapeutics for many years. In particular, we offer services for Fc engineering to control antibody function as well as cell-based functional tests for assessing antibody effector activities.

8888