Recombinant Production of Erythropoietin (EPO): Technical Principles, Challenges, and Advances in Biosimilar Development

Yifan Wang

doi:10.54097/n7dyqs59

Authors

Yifan Wang

DOI:

https://doi.org/10.54097/n7dyqs59

Keywords:

Erythropoietin (EPO) biosimilars; Recombinant DNA technology; Glycosylation; CHO cells.

Abstract

This paper reviews the application of recombinant technology in the production of erythropoietin (EPO), focusing on its production process, selection of expression systems, the critical role of glycosylation in drug activity, and the development and quality control of EPO biosimilars. EPO is a complex glycoprotein essential for anemia treatment; however, its chemical synthesis is highly challenging due to its structural complexity. Therefore, recombinant DNA technology is widely used for large-scale EPO production. The choice of expression system is particularly crucial, with mammalian cells, especially Chinese hamster ovary (CHO) cells, being preferred due to their ability to perform human-like glycosylation. Additionally, this paper analyzes the impact of glycosylation on EPO's stability and bioactivity, along with the limitations of different expression systems in achieving proper glycosylation. With the expiration of EPO patents, biosimilar development is gaining attention. Biosimilars face stringent quality control requirements, including assessments of purity, potency, stability, and immunogenicity, especially to ensure glycosylation patterns consistent with the original drug. Future research directions include optimizing glycosylation through gene editing technologies and employing advanced production techniques to increase yield and reduce costs, ultimately offering more cost-effective treatment options for patients.

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References

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