Case Study: Immunogenicity of rhEPO

  • Arno Kromminga
  • Gilbert Deray
Part of the Biotechnology: Pharmaceutical Aspects book series (PHARMASP, volume VIII)


Erythropoietin is an endogenous growth factor that is required for erythropoiesis. The hormone consists of a single acidic polypeptide chain of 165 amino acids and three N-linked and one O-linked carbohydrate side chains. Autoantibodies against endogenous EPO are extremely rare in humans. Since its introduction as a drug for the treatment of renal and non-renal anemia, antibodies against recombinant human erythropoietin were observed in low frequencies in single cases only. Due to a steep increase in the number of patients developing anti-erythropoietin antibodies during the course of therapy from 1999 to 2004 there is an increased interest in the observation of patients treated with erythropoietin. Moreover, new products as well as modified versions of the natural hormone have entered the market. In addition, modified versions with optimized features as well as peptides mimicking the erythropoietin action are under development and will enter clinical trials soon. These aspects make it essential to screen patients for the presence of anti-EPO antibodies. Despite the lack of a common calibrator, screening assays for the detection of anti-erythropoietin antibodies are available.


Chronic Kidney Disease Renal Anemia Common Calibrator Pharmacovigilance Plan EMEA Guideline 
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© American Association of Pharmaceutical Scientists 2008

Authors and Affiliations

  • Arno Kromminga
  • Gilbert Deray

There are no affiliations available

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