Pure red-cell aplasia due to anti-erythropoietin antibodies

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Abstract
Biopharmaceuticals generated by expression of DNA in cell lines have great potential for the treatment of diseases, in which the endogenous production of a specific protein is inadequately low and/or its administration has beneficial modulating effects on disease processes. Although these drugs are designed as copies of endogenous molecules, immunogenicity is a recognized risk. Factors that have been associated with an immunogenic potential include subtle differences in protein structure and in glycosylation (which is inherently variable), contaminants of the production process, the formulation, storage conditions, patient associated variables and the mode of application, with the i.v. route usually carrying the lowest risk [1].