Immunogenicity of Biopharmaceuticals: VIII - Brossura

 
9781441926081: Immunogenicity of Biopharmaceuticals: VIII
Brossura
ISBN 10: 1441926089 ISBN 13: 9781441926081
Casa editrice: Springer, 2010

Sinossi

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.

Le informazioni nella sezione "Riassunto" possono far riferimento a edizioni diverse di questo titolo.

Contenuti

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.

Le informazioni nella sezione "Su questo libro" possono far riferimento a edizioni diverse di questo titolo.

Editore
Springer
Data di pubblicazione
2010
Lingua
Inglese
ISBN 10 
1441926089
ISBN 13 
9781441926081
Rilegatura
Copertina flessibile
Numero di pagine
280
Redattore
Weert Marco, Møller Eva Horn
Contatto del produttore
ProductSafety@springernature.com
ProductSafety@springernature.com

Poststr. 9
Darmstadt
64293
Germania

Altre edizioni note dello stesso titolo

9780387758404: Immunogenicity of Biopharmaceuticals: VIII

Edizione in evidenza

ISBN 10:  0387758402 ISBN 13:  9780387758404
Casa editrice: Springer-Verlag GmbH, 2008
Rilegato