000			03190nam a22004695i 4500
001			978-0-387-75841-1
003			DE-He213
005			20161121230752.0
007			cr nn 008mamaa
008			100301s2008 xxu| s |||| 0|eng d
020			_a9780387758411 _9978-0-387-75841-1
024	7		_a10.1007/978-0-387-75841-1 _2doi
050		4	_aRM1-950
072		7	_aMMG _2bicssc
072		7	_aMED071000 _2bisacsh
082	0	4	_a615 _223
245	1	0	_aImmunogenicity of Biopharmaceuticals _h[electronic resource] / _cedited by Marco van de Weert, Eva Horn Møller.
264		1	_aNew York, NY : _bSpringer New York, _c2008.
300			_aXII, 266 p. _bonline resource.
336			_atext _btxt _2rdacontent
337			_acomputer _bc _2rdamedia
338			_aonline resource _bcr _2rdacarrier
347			_atext file _bPDF _2rda
490	1		_aBiotechnology: Pharmaceutical Aspects ; _vVIII
505	0		_aImmune 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.
520			_aA 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.
650		0	_aMedicine.
650		0	_aImmunology.
650		0	_aPharmacology.
650	1	4	_aBiomedicine.
650	2	4	_aPharmacology/Toxicology.
650	2	4	_aImmunology.
700	1		_aWeert, Marco van de. _eeditor.
700	1		_aMøller, Eva Horn. _eeditor.
710	2		_aSpringerLink (Online service)
773	0		_tSpringer eBooks
776	0	8	_iPrinted edition: _z9780387758404
830		0	_aBiotechnology: Pharmaceutical Aspects ; _vVIII
856	4	0	_uhttp://dx.doi.org/10.1007/978-0-387-75841-1
912			_aZDB-2-SBL
950			_aBiomedical and Life Sciences (Springer-11642)
999			_c503696 _d503696