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Immunogenicity of Biopharmaceuticals

  • Marco van de Weert
  • Eva Horn Møller

Part of the Biotechnology: Pharmaceutical Aspects book series (PHARMASP, volume VIII)

Table of contents

  1. Front Matter
    Pages I-XI
  2. Simona Malucchi, Antonio Bertolotto
    Pages 27-56
  3. Meenu Wadhwa, Robin Thorpe
    Pages 57-73
  4. Erwin L. Roggen
    Pages 75-95
  5. Arno Kromminga, Gilbert Deray
    Pages 113-126
  6. Klaus Bendtzen, Arno Kromminga
    Pages 127-136
  7. Henriette Mersebach, Fannie Smith, Thomas Sparre, Lisbeth Bjerring Jensen
    Pages 137-146
  8. Silke Ehrenforth, Stephanie Seremetis
    Pages 147-171
  9. Meena Subramanyam
    Pages 173-187
  10. Carmel A. Celestin, John R. Bartholomew
    Pages 205-238
  11. Back Matter
    Pages 259-263

About this book

Introduction

A particular issue for biopharmaceuticals that has not been addressed comprehensively in any book, is the potential of an immune response to the biopharmaceutical product. That is, the human body marks the drug as a foreign body, and develops antibodies against the drug. These antibodies may be relatively harmless, but may also cross-react with the endogenous compound, causing autoimmunogenicity. Recent adverse experiences in Europe with Janssen-Ortho’s blockbuster product Eprex has increased the attention towards potential immunogenicity of biopharmaceuticals, above all from the regulatory agencies.

This book is intended to give a broad overview of the current state-of-the-art regarding the immune response to biopharmaceuticals. The chapters range from an overview of the immune system and factors that may trigger the immune system, via detection of antibodies and clinical implications, to various case examples and the regulatory view on immunogenicity.

Keywords

Biosimilar drug interferon pharmaceutical reaction research

Editors and affiliations

  • Marco van de Weert
    • 1
  • Eva Horn Møller
    • 2
  1. 1.University of CopenhagenCopenhagenDenmark
  2. 2.University of CopenhagenCopenhagenDenmark

Bibliographic information