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.
Preface.- Antibody formation to biologicals - a general overview.- Clinical aspects of immunogenicity to biopharmaceuticals.- Assays to determine the immune response to biopharmaceuticals.- 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-b.- Case study: Immunogenicity of insulin.- Case study: Immunogenicity of Factor VIII.- Case study: Immunogenicity of Natalizumab.- Case study: Immunogenicity of anti-TNF antibodies.- Case study: Heparin-induced thrombocytopenia.- Presenting an immunogenicity risk assessment to regulatory agencies.
Immunogenicity of Biopharmaceuticals is the first book to comprehensively address the potential of an immune response to biopharmaceuticals. It is intended to give a broad overview of the current state-of-the-art regarding this subject. 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.
First book to address the potential of an immune response to the biopharmaceutical product