CHARACTERIZATION OF BIOTHERAPEUTICS

Presented by Diane McCarthy, PhD, Senior Scientific Liaison, Global Biologics, US Pharmacopeia followed by Dr Kai Scheffler, Product Manager at Thermo Fisher Scientific

Biotherapeutic products are typically characterized by multiple orthogonal methods to evaluate product quality and purity, including the assessment of aggregates, variants, and degradation products. For monoclonal antibodies and many other biotherapeutics, analysis of post-translational modifications, such as glycosylation, are also important since these modifications can impact the efficacy, stability, and safety of the final product. This presentation will provide an overview of methods and standards used during characterization, with an emphasis on monoclonal antibodies.