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Immunogenicity of Biopharmaceuticals

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 rela...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor Corporativo: SpringerLink (Online service)
Otros Autores: Weert, Marco (Editor ), Møller, Eva Horn (Editor )
Formato: Electrónico eBook
Idioma:Inglés
Publicado: New York, NY : Springer New York : Imprint: Springer, 2008.
Edición:1st ed. 2008.
Colección:Biotechnology: Pharmaceutical Aspects ; VIII
Temas:
Acceso en línea:Texto Completo
Tabla de Contenidos:
  • 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
  • Heparin-Induced Thrombocytopenia
  • Presenting an Immunogenicity Risk Assessment to Regulatory Agencies.