Blog
About

0
views
0
recommends
+1 Recommend
1 collections
    0
    shares
      • Record: found
      • Abstract: found
      • Article: found

      Evaluation of Methods to Detect and Characterize Antibodies against Recombinant Human Erythropoietin

      Read this article at

      ScienceOpenPublisherPubMed
      Bookmark
          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

          Abstract

          Background: From May 1998 to November 2000, 13 European patients developed antibody-mediated pure red cell aplasia during treatment with recombinant human erythropoietin (rHuEPO), reinforcing the need for analytical testing for antibodies against erythropoietic agents. Specimens from 8 patients were provided for further antibody testing and characterization. Methods: We evaluated 4 analytical methods with these sera: radioimmune precipitation (RIP), enzyme-linked immunosorbent assay (ELISA), biosensor immunoassay, and a bioassay for identification of neutralizing antibodies. Results: The RIP, biosensor immunoassay, and biological assay performed equally to detect and quantify anti-rHuEPO antibodies. The ELISA failed to detect antibodies in 2 patient samples. The biosensor immunoassay could determine antibody isotypes, subclasses, and dissociation rates and the bioassay could determine whether these antibodies were able to neutralize the biological effect of the drug; the other assays could not make this determination. Conclusion: We recommend the use of the biosensor immunoassay followed by a bioassay to best identify and characterize anti-rHuEPO antibodies. The biosensor immunoassay allows for identification of all classes and subclasses of immunoglobulins and is a preferred method for the identification of lower-affinity antibodies. The bioassay is needed to determine if the antibodies identified have the capacity to neutralize a biological effect of the drug in a cell-based system.

          Related collections

          Most cited references 3

          • Record: found
          • Abstract: not found
          • Article: not found

          Autoantibodies against erythropoietin in a patient with pure red-cell aplasia.

            Bookmark
            • Record: found
            • Abstract: not found
            • Article: not found

            Pure red-cell aplasia and recombinant erythropoietin.

              Bookmark
              • Record: found
              • Abstract: not found
              • Article: not found

              Antibodies against Recombinant Human Erythropoietin in a Patient with Erythropoietin-Resistant Anemia

                Bookmark

                Author and article information

                Journal
                NEC
                Nephron Clin Pract
                10.1159/issn.1660-2110
                Nephron Clinical Practice
                S. Karger AG
                1660-2110
                2004
                March 2004
                17 November 2004
                : 96
                : 3
                : c88-c95
                Affiliations
                aAmgen Inc., Clinical Immunology Department, Thousand Oaks, Calif., USA; bInstitut Cochin, Département d’Hématologie, INSERM U567, Université René Descartes, Hôpital Cochin, and cHôpital de l’Hôtel-Dieu, Service d’Hématologie Biologique, INSERM U362, Paris, France
                Article
                76746 Nephron Clin Pract 2004;96:c88–c95
                10.1159/000076746
                15056991
                © 2004 S. Karger AG, Basel

                Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher. Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug. Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.

                Page count
                Figures: 1, Tables: 5, References: 12, Pages: 1
                Product
                Self URI (application/pdf): https://www.karger.com/Article/Pdf/76746
                Categories
                Original Paper

                Comments

                Comment on this article