Phenomenex has published a new method for the analysis of aggregates of erythropoietin (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 an increasing need for method development and validation.
Phenomenex's gel filtration chromatography (GFC) method quantifies aggregates in the recombinant therapeutics using a Biostep-SEC-S2000 series column, which is said to provide a superior separation window for low-molecular-weight proteins.