001469893 000__ 04554cam\\2200577\i\4500
001469893 001__ 1469893
001469893 003__ OCoLC
001469893 005__ 20230803003352.0
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001469893 008__ 230622s2023\\\\sz\\\\\\ob\\\\001\0\eng\d
001469893 020__ $$a9783031319099$$q(electronic bk.)
001469893 020__ $$a3031319095$$q(electronic bk.)
001469893 020__ $$z9783031319082
001469893 0247_ $$a10.1007/978-3-031-31909-9$$2doi
001469893 035__ $$aSP(OCoLC)1385303348
001469893 040__ $$aGW5XE$$beng$$erda$$epn$$cGW5XE$$dEBLCP$$dOCLCF
001469893 049__ $$aISEA
001469893 050_4 $$aRS380$$b.G45 2023
001469893 08204 $$a615/.19$$223/eng/20230622
001469893 1001_ $$aGeigert, J.$$q(John),$$d1948-$$eauthor.
001469893 24514 $$aThe challenge of CMC regulatory compliance for biopharmaceuticals /$$cJohn Geigert.
001469893 250__ $$aFourth edition.
001469893 264_1 $$aCham :$$bSpringer,$$c[2023]
001469893 264_4 $$c©2023
001469893 300__ $$a1 online resource (xxxv, 573 pages)
001469893 336__ $$atext$$btxt$$2rdacontent
001469893 337__ $$acomputer$$bc$$2rdamedia
001469893 338__ $$aonline resource$$bcr$$2rdacarrier
001469893 504__ $$aIncludes bibliographical references and index.
001469893 5050_ $$aBiopharmaceutical Landscape -- Regulatory Pathways Impacting Biopharmaceuticals -- Differences in CMC Regulatory Compliance: Biopharmaceuticals Versus Chemical Drugs -- Risk Management of the Minimum CMC Regulatory Compliance Continuum -- Ever-Present Threat of Adventitious Agent Contamination -- Starting Materials for Manufacturing the Biopharmaceutical Drug Substance -- Upstream Production of the Biopharmaceutical Drug Substance -- Downstream Purification of the Biopharmaceutical Drug Substance -- Manufacturing the Biopharmaceutical Drug Product -- Complex Process-Related Impurity Profiles -- Seemingly Endless Biomolecular Structural Variants -- Indispensable Potency (Biological Activity) -- Biopharmaceutical Critical Quality Attributes -- The Art of Setting Biopharmaceutical Specifications ⁰́b3 Release and Shelf-Life -- The Challenge of Demonstrating Biopharmaceutical Product Comparability -- Strategic CMC-Focused Interactions with Regulatory Authorities.
001469893 506__ $$aAccess limited to authorized users.
001469893 520__ $$aEach year for the past three years, there have been about 50 new molecular medicines approved by the United States Food & Drug Administration (FDA), of which approximately 25% were new biopharmaceuticals. Over 200 recombinant proteins, monoclonal antibodies, antibody drug conjugates, fusion proteins, and Fab fragments are now in the marketplace in both the United States of America (USA) and European Union (EU). There are also now over 60 biosimilars available for all major classes of recombinant proteins and monoclonal antibodies. In addition, gene therapies using genetically engineered viruses and genetically engineered cells are now in the marketplace, and continually growing. This degree of change is reflected in the over 400 CMC regulatory compliance references listed in this book that were either issued or updated since the release of the third edition. Deficiencies in biopharmaceutical CMC regulatory compliance rarely result in termination of a product, but in can readily cause months if not years of delay in initiating clinical trials, or advancing clinical development stages, or even market approval. In summary, this book: Updates real-world CMC deficiency examples with current examples; Addresses current FDA and EMA requirements and expectations for CMC regulatory compliance; Now includes CMC regulatory compliance for the new gene-based biopharmaceuticals.
001469893 588__ $$aOnline resource; title from PDF title page (SpringerLink, viewed June 22, 2023).
001469893 650_0 $$aPharmaceutical biotechnology industry$$xLaw and legislation.
001469893 650_0 $$aPharmaceutical biotechnology$$xQuality control.
001469893 655_0 $$aElectronic books.
001469893 852__ $$bebk
001469893 85640 $$3Springer Nature$$uhttps://univsouthin.idm.oclc.org/login?url=https://link.springer.com/10.1007/978-3-031-31909-9$$zOnline Access$$91397441.1
001469893 909CO $$ooai:library.usi.edu:1469893$$pGLOBAL_SET
001469893 980__ $$aBIB
001469893 980__ $$aEBOOK
001469893 982__ $$aEbook
001469893 983__ $$aOnline
001469893 994__ $$a92$$bISE