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336			_aTexto _btxt _2rdacontent
710	2		_aSpringerLink (Online service) _9106996
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008			190508s2019 gw | o |||| 0|eng d
020			_a9783030137540
024	7		_a10.1007/978-3-030-13754-0 _2doi
050		4	_aRS380 _b2019 EB
100	1		_aGeigert, John _eautor _4http://id.loc.gov/vocabulary/relators/aut _984732
245	1	4	_aThe Challenge of CMC Regulatory Compliance for Biopharmaceuticals _cby John Geigert.
250			_a3rd ed. 2019.
264		1	_aCham, Switzerland _bSpringer International Publishing _c2019
300			_a1 recurso en línea (XXVIII, 426 páginas) _b59 ilustraciones, 34 ilustraciones a color
337			_aelectrónico _bc
338			_arecurso electrónico _bcr
347			_atext file _bPDF
490	0		_aBiomedical and Life Sciences (Springer-11642)
505	0		_aComplexity of Biologics CMC Regulation -- Biopharmaceutics are Not Chemical Drugs -- An Effective CMC Strategy is Possible -- Challenge of Adventitious Agent Control -- Biopharmaceutical Source Materials -- Manufacturing of Biopharmaceutical APIs -- Manufacturing of the Drug Product -- Complex Process-Related Impurity Profiles -- Product Characterization is a Journey -- Priceless Potency (Therapeutic Activity) -- Quality Attributes of a Biopharmaceutical -- Designing the Stability Program -- The Art of Setting Specifications -- Demonstrating Product Comparability After Process Changes -- Invaluable CMC-Focused Meetings with Regulatory Authorities.
520	3		_aThis book since first published in 2004 has been a major resource providing insights and practical guidance for the CMC teams to develop an acceptable cost-effective, risk-based CMC regulatory compliance strategy for biopharmaceuticals (recombinant proteins, monoclonal antibodies, genetically engineered viruses and genetically engineered human cells) from early clinical stage development through market approval. The third edition of this book provides added coverage for the biosimilars, antibody drug conjugates (ADCs), bispecific antibodies, genetically engineered viruses, and genetically engineered cells. This third edition of the book also addresses the heightened pressure on CMC regulatory compliance timelines due to the introduction of expedited clinical pathways moving the clinical development closer to a seamless phase process (e.g., FDA Breakthrough Therapy designation, CBER Regenerative Medicine Advanced Therapy (RMAT) designation, EMA Priority Medicines (PRIME) designation). The Challenge of CMC Regulatory Compliance for Biopharmaceuticals is essential, practical information for all pharmaceutical development scientists, Manufacturing and Quality Unit staff, Regulatory Affairs personnel, and senior management involved in the manufacture of biopharmaceuticals.
988			_aPrimersemestre_2019_BiomedLife
650		7	_2embne _9155839 _aBiotecnología farmacéutica
650		7	_2embne _aToxicología _9140328
776	0	8	_iPrinted edition: _z9783030137533
776	0	8	_iPrinted edition: _z9783030137557
776	0	8	_iPrinted edition: _z9783030137564
856	4	0	_uhttps://go.openathens.net/redirector/universidadeuropea.es?url=https://doi.org/10.1007/978-3-030-13754-0 _zAcceso a este recurso digital (usuarios Universidad Europea de Madrid)
942			_2lcc _cLE
998			_aSI _cm _dz _feng _ggw _h0 _b09/2019 _ek _zSI