Erythropoietin (EPO) biologics generate substantial revenue for the biopharma industry and, as their patents expire, the market for EPO biosimilars is set to grow considerably.
Analysis of the glycosylation of EPO is a challenging requirement for drug developers because this glycoprotein hormone exhibits significant heterogeneity and its high degree of sialylation and accompanying acetylation can significantly affect its therapeutic properties (particularly the circulation half-life).
Ludger has developed accurate and reliable methods for analysis of EPO.
For example Ludger’s DMB sialic acid technology (LudgerTag DMB kit, Cat # LT-KDMB-A1) can be used to obtain information on the relative levels of the N-acetyl, N-glycolyl and O-acetyl sialic acids. This information can be used in QC to monitor batch-to-batch variation, or for comparability studies.
It can also execute detailed characterisation studies of EPO using LC and MS to give you the information you require. This includes site specific glycosylation analysis to determine the following:
* Percentage site occupancy for each N-glycan and O-glycan site
* Glycan profile for each glycosylation site, with GU and relative proportions
* Identification of glycans at each glycosylation site (by comparison to structures identified from released glycan analysis).
