Webinar:

FcRn Affinity Column

Sponsored by: Roche Diagnostics GmbH

Focused on:

  • Antibody
  • Novel Affinity Column

Date: 17 October

Days to go: 57

Time: 4PM London/11AM New York

A powerful tool for characterization of therapeutic monoclonal antibodies (mABs)

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.


FcRn Affinity Column is for use in quality control / manufacturing process only

Presented by

Dr. Tilman Schlothauer,

Senior Principal Scientist

Tilman Schlothauer joined Roche in 2004 as a Post-Doc in the Department of Biochemistry. He studied chemistry at the University of Marburg. He started his Ph.D. at the University of Freiburg at the Institute for Biochemistry and Molecular Biology and finished it at the Center of Molecular Biology Heidelberg (ZMBH) in 2004. Since 2006 Tilman is in a Group Leader position in the Department of Biochemical and Analytical Research and since 2008 also Project Leader in the Technology Project Immune Effector Functions.

In the Group Leader position he develops cell free functional assays for therapeutic protein characterization with respect to target binding and Fc functionality of mAb type API (active pharmaceutical ingredient).

Key Learning Objectives

  • Antibody Fc functionality, FcRn interaction of mAB, current FcRn interaction methods and their limitations
  • FcRn chromatography: how it mimics physiological conditions of antibody and albumin recycling
  • Case studies by Roche Pharma: How FcRn chromatography was used to increase quality and improve the drug development process

Audience

  • Biomanufacturing
  • Bioprocess Control
  • Bioprocess Analytics
  • Functional antibody characterization
  • Director
  • Manager
  • Technician
  • Scientist
  • Compliance
  • Engineering
  • Quality Assurance
  • Quality Control
  • Regulatory Affairs
  • Research and Development
  • Validation
  • Release Testing