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000890457 019__ $$a1105176703
000890457 020__ $$a9783030137540$$q(electronic book)
000890457 020__ $$a3030137546$$q(electronic book)
000890457 020__ $$z9783030137533
000890457 0248_ $$a10.1007/978-3-030-13
000890457 035__ $$aSP(OCoLC)on1101779381
000890457 035__ $$aSP(OCoLC)1101779381$$z(OCoLC)1105176703
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000890457 049__ $$aISEA
000890457 050_4 $$aRS380$$b.G45 2019
000890457 08204 $$a615/.19$$223
000890457 1001_ $$aGeigert, J.$$q(John),$$d1948-
000890457 24514 $$aThe challenge of CMC regulatory compliance for biopharmaceuticals /$$cJohn Geigert.
000890457 2463_ $$aChallenge of chemistry, manufacturing, and control regulatory compliance for biopharmaceuticals
000890457 250__ $$aThird edition.
000890457 264_1 $$aCham, Switzerland :$$bSpringer,$$c[2019]
000890457 300__ $$a1 online resource
000890457 336__ $$atext$$btxt$$2rdacontent
000890457 337__ $$acomputer$$bc$$2rdamedia
000890457 338__ $$aonline resource$$bcr$$2rdacarrier
000890457 504__ $$aIncludes bibliographical references and index.
000890457 5050_ $$aComplexity of Biologics CMC Regulation -- Biopharmaceutics are Not Chemical Drugs -- An Effective CMC Strategy is Possible -- Challenge of Adventitious Agent Control -- Biopharmaceutical Source Materials -- Manufacturing of Biopharmaceutical APIs -- Manufacturing of the Drug Product -- Complex Process-Related Impurity Profiles -- Product Characterization is a Journey -- Priceless Potency (Therapeutic Activity) -- Quality Attributes of a Biopharmaceutical -- Designing the Stability Program -- The Art of Setting Specifications -- Demonstrating Product Comparability After Process Changes -- Invaluable CMC-Focused Meetings with Regulatory Authorities.
000890457 506__ $$aAccess limited to authorized users.
000890457 520__ $$aThis book since first published in 2004 has been a major resource providing insights and practical guidance for the CMC teams to develop an acceptable cost-effective, risk-based CMC regulatory compliance strategy for biopharmaceuticals (recombinant proteins, monoclonal antibodies, genetically engineered viruses and genetically engineered human cells) from early clinical stage development through market approval. The third edition of this book provides added coverage for the biosimilars, antibody drug conjugates (ADCs), bispecific antibodies, genetically engineered viruses, and genetically engineered cells. This third edition of the book also addresses the heightened pressure on CMC regulatory compliance timelines due to the introduction of expedited clinical pathways moving the clinical development closer to a seamless phase process (e.g., FDA Breakthrough Therapy designation, CBER Regenerative Medicine Advanced Therapy (RMAT) designation, EMA Priority Medicines (PRIME) designation). The Challenge of CMC Regulatory Compliance for Biopharmaceuticals is essential, practical information for all pharmaceutical development scientists, Manufacturing and Quality Unit staff, Regulatory Affairs personnel, and senior management involved in the manufacture of biopharmaceuticals.
000890457 588__ $$aDescription based on online resource; title from digital title page (viewed on June 25, 2019).
000890457 650_0 $$aPharmaceutical biotechnology industry$$xLaw and legislation.
000890457 650_0 $$aPharmaceutical biotechnology$$xQuality control.
000890457 77608 $$iPrint version:$$aGeigert, John$$tThe Challenge of CMC Regulatory Compliance for Biopharmaceuticals$$dCham : Springer,c2019$$z9783030137533
000890457 852__ $$bebk
000890457 85640 $$3SpringerLink$$uhttps://univsouthin.idm.oclc.org/login?url=http://link.springer.com/10.1007/978-3-030-13754-0$$zOnline Access$$91397441.1
000890457 909CO $$ooai:library.usi.edu:890457$$pGLOBAL_SET
000890457 980__ $$aEBOOK
000890457 980__ $$aBIB
000890457 982__ $$aEbook
000890457 983__ $$aOnline
000890457 994__ $$a92$$bISE