Herceptin Fc-Gamma Receptor Binding Assays

BioOutsource provides a comprehensive portfolio of off-the-shelf Fc-Gamma Receptor (FcR) binding assays for Herceptin by Surface Plasmon Resonance using the Biacore T200 or 4000. These Herceptin Fc Receptor binding assays can be used to rapidly accelerate development and manufacture of biosimilar Herceptin in a cost effective manner. Our assays are used to support Herceptin biosimilar process development, assessing material produced from different clones, different production processes or prepared in different formulations. We offer industry leading Herceptin comparability and Herceptin characterization services and these can be adapted for your product, if required.

The Fc-Gamma Receptors (FcR) are members of the immunoglobulin superfamily and play a critical role in the function of Herceptin (trastuzumab). The Fc-Gamma Receptors (FcR) can be divided into three types, Fc-Gamma Receptor I (FcRI/CD64), Fc-Gamma Receptor II (FcRII/CD32) and Fc-Gamma Receptor III (FcRIII/CD16). Both the FcRII and FcRIII can be further divided into FcRIIa/FcRIIb and FcRIIIa/FcRIIIb. Historically, these receptors have been categorized based upon their affinity for specific IgG subclasses and whether their binding initiates activating or inhibitory signals. Following binding of Herceptin (trastuzumab) to Her2/neu, the subsequent binding of the FcRs is a crucial step for the initiation and control of cell-mediated effector functions of the immune system. Whilst FcRI is capable of binding monomeric IgG with high affinity, both FcRII and FcRIII have the capacity to bind IgG complexes and the binding can be affected by genetic polymorphisms of the receptors as well as different glycosylation patterns in the Fc region of the Herceptin molecule.

The Herceptin Fc-Gamma Receptor assays offered by BioOutsource are performed using the Biacore T200 or 4000, which are versatile, label-free systems with exceptional sensitivity. The Biacore T200 is the most sensitive SPR instrument available from GE Healthcare, and provides the optimal platform for evaluating both high affinity Fab binding characterization as well as Fc-Gamma Receptor binding, whereas the 4000 balances high levels of sensitivity with greater sample throughput. The following Herceptin (trastuzumab) Fc-Gamma Receptor assays are offered by BioOutsource:

  • Herceptin Fc-Gamma Receptor I (FcRI) binding assay by SPR
  • Herceptin Fc-Gamma Receptor IIa (FcRIIa) binding assay by SPR
  • Herceptin Fc-Gamma Receptor IIb (FcRIIb) binding assay by SPR
  • Herceptin Fc-Gamma Receptor IIIa (V) (FcRIIIa V) binding assay by SPR
  • Herceptin Fc-Gamma Receptor IIIa (F) (FcRIIIa F) binding assay by SPR
  • Herceptin Fc-Gamma Receptor IIIb (FcRIIIb) binding assay by SPR