Humira FcRn Binding Assays

A key factor in the efficacy of therapeutic antibodies is the serum half-life and this is largely determined by the interaction between the antibody and the neonatal Fc receptor (FcRn). Evaluation and understanding of your antibody product’s ability to bind FcRn can play a pivotal role in developing a safe and efficacious molecule and is critical in demonstrating comparability between Humira biosimilar and innovator.

The neonatal Fc Receptor (FcRn) is an MHC class-I-like molecule associated with beta-2-microglobulin and prevents the degradation of IgG, prolonging the half life in vivo. FcRn functions include the mediation of bidirectional transcytosis of IgG across cell membranes as well enhancement of IgG mediated phagocytosis and antigen presentation. The binding affinity of FcRn for IgG is negligible at physiological pH and the binding interaction can only occur following pincytosis within the early endosome; the IgG/FcRn complex can then be returned to the cell surface.

BioOutsource provides off-the-shelf Humira FcRn binding assays by surface plasmon resonance (SPR) using the Biacore T200, which is a versatile, label-free system with exceptional sensitivity. As the most recent SPR machine from GE Healthcare, its increased sensitivity provides the optimal platform for evaluation of IgG/FcRn binding interactions. We have extensive experience analyzing Humira biosimilar and innovator material and our Humira FcRn binding assay services can be used to determine the Binding Affinity Constant (KD).

Our experience in the development and qualification of methods makes BioOutsource the perfect partner to support you as you progress from clone ranking and candidate selection through the clinical phases.

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