New Method for EPO (Erythropoietin) Impurity Analysis

New Solution Meets Growing Method Development Needs as Patents Expire

Phenomenex Inc., a global leader in the research and manufacture of advanced technologies for the separation sciences, announces the publication of a new method for the analysis of aggregates of EPO, a widely manufactured recombinant biosimilar protein therapeutic. As patent protection expires for the original EPO drugs, many companies are working to produce generic versions, resulting in a skyrocketing need for method development and validation. The new gel filtration chromatography (GFC) method developed by Phenomenex quantifies aggregates in these recombinant therapeutics using a BioSep-SEC-s2000 series column, which provides a superior separation window for low-molecular-weight proteins.

“Our published data shows a clear advantage in using this BioSep column and our GFC method, over the columns used in the past,” explains Michael McGinley, HPLC product manager for Phenomenex. “This rugged yet simple method effectively analyzes the amount of aggregate and dimer in these low-molecular-weight samples.”

A technical note on the new Phenomenex EPO method has just been published and can be accessed at: www.phenomenex.com/epo

Phenomenex is a global technology leader committed to developing novel analytical chemistry solutions that solve the separation and purification challenges of researchers in industrial, clinical, government and academic laboratories. From drug discovery and pharmaceutical development to disease diagnosis, food safety and environmental analysis, Phenomenex chromatography solutions accelerate science and help researchers improve global health and well-being. For more information on Phenomenex, visit www.phenomenex.com