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Title Immunogenicity of biopharmaceuticals / [edited by] Marco van de Weert, Eva Horn Møller
Published New York : Springer ; Arlington, VA : AAPS Press, ©2008


Description 1 online resource (xi, 263 pages, 2 unnumbered pages of plates) : illustrations (some color)
Series Biotechnology : pharmaceutical aspects ; v. 8
Biotechnology (Arlington, Va.) ; v. 8.
Contents Front Matter; Immune Reactions Towards Biopharmaceuticals -- a General, Mechanistic Overview; Clinical Aspects of Immunogenicity to Biopharmaceuticals; Assessment of Unwanted Immunogenicity; Models for Prediction of Immunogenicity; Immunogenicity of Biopharmaceuticals: Causes, Methods to Reduce Immunogenicity, and Biosimilars; Case Study: Immunogenicity of rhEPO; Case Study: Immunogenicity of Interferon-Beta; Case Study: Immunogenicity of Insulin; Case Study: Immunogenicity of Factor VIII; Case Study: Immunogenicity of Natalizumab; Case Study: Immunogenicity of Anti-TNF Antibodies
Summary 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
Bibliography Includes bibliographical references and index
Notes Print version record
Subject Biopharmaceutics -- Immunology
Immunological tolerance.
Pharmaceutical biotechnology.
Immune Tolerance
MEDICAL -- Immunology.
Pharmaceutical biotechnology.
Biopharmaceutics -- Immunology.
Immunological tolerance.
Sciences de la vie.
Immunological tolerance
Pharmaceutical biotechnology
Form Electronic book
Author Weert, Marco van de, 1973-
Møller, Eva Horn
ISBN 9780387758411