Immunogenicity of therapeutic proteins.

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Abstract
A year ago Nicole Casadevall of the Hotel‐Dieu in Paris and her colleagues published their first 13 cases of pure red‐cell aplasia (PRCA) associated with the use of erythropoietin (Epo) in patients with chronic renal failure [1]. As of November 2002, the number of antibody‐mediated reported cases in Europe, Canada and Australia has increased to more than 175. The most likely explanation for this serious side effect is a subtle change in the Epo molecule that may occur during the manufacturing and formulation process, or in the handling and distribution processes.