New webinar: optimizing analytics for biosimilars

How providing comprehensive data can accelerate drug development.

During the one-hour webinar, Dr Martin De Cecco, and Dr Terry Gray will explore the impact of differing glycan structures on antibody function using a case study comparing biosimilar infliximab to the innovator molecule Remicade. Drawing on real-life examples, both experts will discuss a variety of orthogonal methods, including glycan analysis by LCMS, CD16a and SPR binding, as well as ADCC activity that will highlight the benefits of performing combined structural and functional analysis. They will also be discussing the importance of choosing appropriate analytical assays at each stage of the product’s development and how utilizing a comprehensive testing package can provide evidence suitable for regulatory submissions to enable biosimilars to enter clinical programs more rapidly.

Dr Daniel Galbraith, Chief Scientific Officer of Sartorius Stedim BioOutsource, stated: “The complex nature of monoclonal antibodies often results in differences between the biosimilar and innovator molecule and the key to regulatory acceptance is understanding the potential clinical significance of those residual differences. We’re delighted to be hosting a webinar during which our experts will explain how generating comprehensive characterization data for the regulators can overcome reservations about a new monoclonal, to deliver faster and more cost-effective biosimilar drug development.”