Recombinant human EPO

Neorecormon (tradename, also known as epoetin beta) is a recombinant human EPO first approved for medical use in the EU in 1997. It is indicated for the treatment of anaemia associated with various medical conditions, most commonly chronic renal failure and cancer patients receiving chemotherapy. Neorecormon is produced by recombinant DNA technology in a CHO cell line and is manufactured as outlined in Figure 10.5. It is presented in lyophilized format at various strengths (500-10 000 IU/vial) and contains phosphate buffer, sodium chloride, calcium chloride, urea, polysorbate and various amino acids as excipients. 

EPO was first used therapeutically in 1989 for the treatment of anaemia associated with chronic kidney failure. This anaemia is largely caused by insufficient endogenous EPO production by the diseased kidneys. Prior to EPO approval this condition could only be treated by direct blood transfusion. It responds well, and in a dose-dependent manner, to the administration of recombinant human EPO (rhEPO). The administration of EPO is effective, both in the case of patients receiving dialysis and those who have not yet received this treatment. 

Biopharmaceutical quantities of EPO are produced with recombinant cells. This is achieved through the isolation of the human gene that codes for EPO and transfection of the gene into cell lines such as Chinese hamster ovary cells (see Section 10.5). The product is called rhEPO—recombinant human EPO. EPO is normally administered subcutaneously and is generally well tolerated by patients. 

Glycoproteomics of AFP, Fibrinogen, and Recombinant Human EPO, Based On the Reverse Glycoblotting Protocol"... 

Epotein alpha or Epogen is an aqueous formulation of recombinant human EPO expressed in CHO cells. Erythropoietin is a 166-aa glycoprotein with an MW of 34kDa. It is heavily glycosylated with carbohydrates accounting for 38% of the Human EPO has... 

Thus far, at least two approved therapeutic proteins are engineered by modification of their glycocomponent Nespo (Aranesp in the US) is a recombinant human EPO molecule expressed in a CHO cell line. Native EPO harbors three N-linked carbohydrate side-chains, whereas the engineered recombinant product displays five... 

EU epoetin delta hematopoiesis Dynepo Recombinant human EPO expressed using Trans Kayrotic Therapies gene activation process. This protein, EPO delta, is currently held up by patent infringement suits Hematopoiesis... 

Abelian, R., Ventura, R., Pichini, S., et al. (2004) Evaluation of immunoassays for the measurement of erythropoietin (EPO) as an indirect biomarker of recombinant human EPO misuse in sport. Journal of Pharmaceutical and Biomedical Analysis, 35,1169-1177. 

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