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Immunogenicity of biopharmaceuticals

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Author: Search for this author Weert, Marco van de; Möller, Eva Horn
Year: 2008
Publisher: New York, NY, Springer
Media group: Ausleihbestand
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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 have 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.

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Author: Search for this author Weert, Marco van de; Möller, Eva Horn
Statement of Responsibility: Marco van de Weert ; Eva Horn Moeller
Year: 2008
Publisher: New York, NY, Springer
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Classification: Search for this systematic ME-30, ZB-90
Subject type: Search for this subject type Monographien
ISBN: 9780387758404
ISBN (2nd): 0-387-75840-2
Description: Xi, 263 S. : Ill., graph. Darst.
Tags: Pharmazie; Immunbiologie
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Language: englisch||
Footnote: Literaturangaben
Media group: Ausleihbestand