FcRn Affinity Column Chromatography for Therapeutic mAb Characterization

Fc receptor based affinity chromatography is a new emerging field of Fc functionality analytics. FcRn affinity columns separate antibody species that differ in their affinity to FcRn using conditions that closely resemble the physiological mechanism of IgG and FcRn interaction. This opens up a broad range of new applications using this technology.

 

Stability and pharmacokinetic properties are essential parameters for the successful design of therapeutic monoclonal antibodies (mAbs) because production and storage conditions can lead to mAb heterogeneity and reduced serum half-life.

 

Current methods to assess mAb homogeneity include mouse in vivo assays and biophysical characterizations, but these are often complicated and laborious, or a poor representation of human physiology. Roche Pharmaceuticals has developed a novel affinity column that uses immobilized neonatal Fc receptors (FcRn). In vivo, FcRn mediates a cellular recycling mechanism that salvages intact immunoglobulins from lysosomal degradation. Separation on the Roche FcRn affinity column mimics this physiological process in vitro to characterize antibody species based on their affinity to FcRn receptors.

 

FcRn chromatography conditions are designed to provide information on mAb homogeneity and stability over the entire range of physiologically relevant pH conditions in just a single experiment. In-house data obtained at Roche Pharmaceuticals show that the FcRn affinity column is a fast and robust tool to evaluate antibody pharmacokinetic properties.

 

Join us for this webinar to learn how Roche CustomBiotech FcRn affinity columns work, and how they can be easily implemented into your development workflow to support the design of new antibodies, mAb formats, or Fc fusion proteins.