Complete and Rapic Characterization Candidate Biosimilars Part 3
Applying the European Pharmacopoeia Method for Quantitation of Recombinant Human Erythropoietin (rhEPO) Isoforms
Erythropoietin (EPO) is a naturally occurring hormone that stimulates red blood cell production and release from bone marrow. EPO was one of the first therapeutic recombinant glycoproteins commercialized for the treatment of anemia. It is known to have complex N- and O-linked glycosylation patterns and can exist as numerous protein isoforms. These glycosylation patterns play a critical role in the bioavailability, activity, potency and stability of EPO.
Proper characterization of EPO is extremely important in order to ensure its comparability and efficacy. This webinar provides guidance for the preparation of an EPO suitability standard and will show how the European Pharmacopoeia (Eu.Ph.) method is implemented. In addition, this webinar will discuss:
A collaborative study initiated by the European Directorate for the Quality of Medicine (EDQM) establishing Capillary Zone Electrophoresis (CZE) as the method of choice for the quantitation of EPO isoforms.
How the recent development of CESI-MS enabled the identification and quantitation of multiple glycoforms of rhEPO under native conditions as well as a middle-down approach to assess site-specific N- and O-glycosylation.
Key Learning Points
Learn how to correctly implement the European Pharmacopoeia (Eu.Ph.) standard method for quantitation of isoforms of recombinant human Erythropoietin (rhEPO)
Discover the latest mass spectrometry approaches for the characterization of EPO isoforms
Understand how site-specific N- and O- glycosylation may be quantified