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Nephrol Dial Transplant (2003) 18: 1257-1259
© 2003 European Renal Association-European Dialysis and Transplant Association

Editorial Comment

Immunogenicity of therapeutic proteins

Huub Schellekens

Central Laboratory Animal Institute and Department of Innovation Studies, Utrecht University, Utrecht, The Netherlands

Keywords: biopharmaceuticals; Epo; erythropoietin; immune tolerance; immunogenicity

The first 10% of the full text of this article appears below.

Introduction

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.

Apparently a change in the product leads to the induction of antibodies neutralizing the endogenous Epo in these patients causing a complete block in the differentiation of red blood cells. The increased s.c. use and self administration with inappropriate use, handling and storage . . . [Full Text of this Article]

History of the use of therapeutic proteins

Immunization or breaking tolerance

Factors influencing the incidence of antibody induction

Consequences of antibodies

Conclusion


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