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Immunogenicity of Biopharmaceuticals (Hardcover, 2008 ed.)
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Immunogenicity of Biopharmaceuticals (Hardcover, 2008 ed.)
Series: Biotechnology: Pharmaceutical Aspects, VIII
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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 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.
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