Erythropoietin-Alpha Fc-Chimera (Human Recombinant), often abbreviated as EPO-α/Fc, is a recombinant form of EPO that has been engineered to include the Fc region of human IgG1. This fusion enhances the stability and half-life of the protein in the bloodstream . The Fc component contains the CH2 domain, the CH3 domain, and the hinge region, which contribute to the extended half-life by interacting with the neonatal Fc receptor (FcRn) and protecting the protein from lysosomal degradation .
The recombinant EPO-α/Fc is produced in Chinese hamster ovary (CHO) cells, which are commonly used in biotechnology for the production of therapeutic proteins due to their ability to perform complex post-translational modifications, including glycosylation . Glycosylation is essential for the biological activity and stability of EPO, as it affects the protein’s solubility, resistance to proteolysis, and receptor binding affinity .
Recombinant human EPO and its analogs, including EPO-α/Fc, are widely used as erythropoiesis-stimulating agents (ESAs) in the treatment of anemia associated with chronic kidney disease (CKD), cancer, and other conditions . By stimulating erythropoiesis, these agents help to increase red blood cell counts and improve oxygen delivery to tissues, thereby alleviating the symptoms of anemia .
In addition to its role in erythropoiesis, EPO has been found to have neuroprotective and anti-apoptotic effects in various tissues . These properties have sparked interest in the potential use of EPO and its derivatives in the treatment of neurological disorders and other conditions involving cell death and tissue damage .
The production of recombinant EPO-α/Fc involves the transfection of CHO cells with the human EPO gene or cDNA linked to an expression vector . The transfected cells are then cultured, and the recombinant protein is secreted into the culture medium. The protein is subsequently purified using techniques such as affinity chromatography, which exploits the Fc region’s affinity for protein A or protein G, commonly used ligands in purification processes .
The purified EPO-α/Fc is typically lyophilized (freeze-dried) for stability and ease of storage. It is recommended to reconstitute the lyophilized protein in sterile water and store it at low temperatures to maintain its stability and biological activity .