000			03586nam a2200337 i 4500
999			_c399354 _d399354
001			399354
003			ES-MaUEC
005			20240415160900.0
006			a||||fo|||| 00| 0
007			cr nn 008mamaa
008			230615s2023 sz | fo |||| 0|eng d
020			_a9783031319099
024	7		_a10.1007/978-3-031-31909-9 _2doi
040			_aES-MaUEC _bspa _cES-MaUEC _dES-MaUEC
050		4	_aRS380 _b2023 EB
100	1		_aGeigert, John _eautor _4aut _4http://id.loc.gov/vocabulary/relators/aut _984732
245	0	4	_aThe Challenge of CMC Regulatory Compliance for Biopharmaceuticals _cby John Geigert
250			_a4th ed. 2023
264		1	_aCham _bSpringer Nature Switzerland _c2023
300			_a1 recurso en línea
336			_atexto _btxt _2rdacontent
337			_aelectrónico _bc _2rdamedia
338			_arecurso electrónico _bcr _2rdacarrier
505	0		_aBiopharmaceutical Landscape -- Regulatory Pathways Impacting Biopharmaceuticals -- Differences in CMC Regulatory Compliance: Biopharmaceuticals Versus Chemical Drugs -- Risk Management of the Minimum CMC Regulatory Compliance Continuum -- Ever-Present Threat of Adventitious Agent Contamination -- Starting Materials for Manufacturing the Biopharmaceutical Drug Substance -- Upstream Production of the Biopharmaceutical Drug Substance -- Downstream Purification of the Biopharmaceutical Drug Substance -- Manufacturing the Biopharmaceutical Drug Product -- Complex Process-Related Impurity Profiles -- Seemingly Endless Biomolecular Structural Variants -- Indispensable Potency (Biological Activity) -- Biopharmaceutical Critical Quality Attributes -- The Art of Setting Biopharmaceutical Specifications - Release and Shelf-Life -- The Challenge of Demonstrating Biopharmaceutical Product Comparability -- Strategic CMC-Focused Interactions with Regulatory Authorities.
520			_aEach year for the past three years, there have been about 50 new molecular medicines approved by the United States Food & Drug Administration (FDA), of which approximately 25% were new biopharmaceuticals. Over 200 recombinant proteins, monoclonal antibodies, antibody drug conjugates, fusion proteins, and Fab fragments are now in the marketplace in both the United States of America (USA) and European Union (EU). There are also now over 60 biosimilars available for all major classes of recombinant proteins and monoclonal antibodies. In addition, gene therapies using genetically engineered viruses and genetically engineered cells are now in the marketplace, and continually growing. This degree of change is reflected in the over 400 CMC regulatory compliance references listed in this book that were either issued or updated since the release of the third edition. Deficiencies in biopharmaceutical CMC regulatory compliance rarely result in termination of a product, but in can readily cause months if not years of delay in initiating clinical trials, or advancing clinical development stages, or even market approval. In summary, this book: Updates real-world CMC deficiency examples with current examples; Addresses current FDA and EMA requirements and expectations for CMC regulatory compliance; Now includes CMC regulatory compliance for the new gene-based biopharmaceuticals.
988			_aSpringer_BiomedLife_2023
650		7	_2embne _9155839 _aBiotecnología farmacéutica
856	4	0	_uhttps://go.openathens.net/redirector/universidadeuropea.es?url=https://doi.org/10.1007/978-3-031-31909-9 _zAcceso a este recurso digital (usuarios Universidad Europea de Madrid)
942			_2lcc _cLE
998			_b04/2024 _dz _eb _zSI