Document Detail

Epoetins: differences and their relevance to immunogenicity.
MedLine Citation:
PMID:  13678480     Owner:  NLM     Status:  MEDLINE    
Recombinant human erythropoietin (epoetin) is a highly active molecule and as such is used at very low therapeutic concentrations that require stabilisation. Commercially available epoetins differ in the stabilisers used in their formulations, which result in variations between epoetin preparations in storage and handling requirements. The stability and solubility of the epoetins are also affected by differences in the carbohydrate moieties that exist between them. However, it is the difference in stabilising agents that is thought to be the major cause of the upsurge in pure red cell aplasia (PRCA) cases observed predominantly with one epoetin alfa formulation, Eprex (Johnson & Johnson). In 1998 the European formulation of Eprex was changed with the replacement of human serum albumin (HSA), by polysorbate 80 and glycine. This formulation change coincided with an increased incidence of PRCA. In contrast, the incidence of PRCA has remained low with other HSA-containing epoetin alfa products and with epoetin beta. Therefore, it appears that the change in Eprex formulation has resulted in reduced protein stability and increased immunogenicity.
Anton Haselbeck
Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't; Review    
Journal Detail:
Title:  Current medical research and opinion     Volume:  19     ISSN:  0300-7995     ISO Abbreviation:  Curr Med Res Opin     Publication Date:  2003  
Date Detail:
Created Date:  2003-09-18     Completed Date:  2004-03-24     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  0351014     Medline TA:  Curr Med Res Opin     Country:  England    
Other Details:
Languages:  eng     Pagination:  430-2     Citation Subset:  IM    
Roche Diagnostics GmbH, D-82372 Penzberg, Germany.
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MeSH Terms
Antibody Formation / drug effects*
Chemistry, Pharmaceutical
Drug Administration Routes
Drug Stability
Drug Storage
Erythropoietin, Recombinant / adverse effects*,  chemistry,  immunology*
Red-Cell Aplasia, Pure / chemically induced*
Reg. No./Substance:
0/Erythropoietin, Recombinant; 0/Excipients

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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