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001434041 001__ 1434041
001434041 003__ OCoLC
001434041 005__ 20230309003707.0
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001434041 008__ 210220s2021\\\\sz\\\\\\o\\\\\001\0\eng\d
001434041 019__ $$a1237558369$$a1241066357$$a1243389390$$a1244117636
001434041 020__ $$a9783030571771$$q(electronic bk.)
001434041 020__ $$a3030571777$$q(electronic bk.)
001434041 020__ $$z9783030571764
001434041 020__ $$z3030571769
001434041 0247_ $$a10.1007/978-3-030-57177-1$$2doi
001434041 035__ $$aSP(OCoLC)1237865866
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001434041 049__ $$aISEA
001434041 050_4 $$aRM301.25
001434041 08204 $$a615.1/9$$223
001434041 24500 $$aProtein instability at interfaces during drug product development :$$bfundamental understanding, evaluation, and mitigation /$$cJinjiang Li, Mary E. Krause, Raymond Tu, editors.
001434041 264_1 $$aCham :$$bSpringer :$$bAAPS,$$c[2021]
001434041 300__ $$a1 online resource (340 pages)
001434041 336__ $$atext$$btxt$$2rdacontent
001434041 337__ $$acomputer$$bc$$2rdamedia
001434041 338__ $$aonline resource$$bcr$$2rdacarrier
001434041 347__ $$atext file
001434041 347__ $$bPDF
001434041 4901_ $$aAAPS advances in the pharmaceutical sciences ;$$v43
001434041 500__ $$aIncludes index.
001434041 5050_ $$a1. Overview of the impact of protein interfacial instability on the development of biologic products -- 2. Protein adsorption at a gas-aqueous interface -- 3. Interfacial behaviors of proteins -- 4. Interfacial stresses during drug substance purification processes -- 5. Evaluation of interfacial stress during drug product development -- 6. Relating interfacial shear and dilatations stress-es to protein aggregation in mAbs -- 7. Analytical techniques for evaluating protein instability at interfaces -- 8. Analysis of aggregates and particles -- 9. Protein interfacial instability of mixing and lyophilization during drug product manufacturing process scale-up and tech transfer -- 10. Excipients: Characterization, purpose, and selection -- 11. Interfacial stress and proteins prepared in the solid state -- 12. Interfaces in protein drug delivery: device concern -- 13. Future perspectives.
001434041 506__ $$aAccess limited to authorized users.
001434041 520__ $$aProteins are exposed to various interfacial stresses during drug product development. They are subjected to air-liquid, liquid-solid, and, sometimes, liquid-liquid interfaces throughout the development cycle-from manufacturing of drug substances to storage and drug delivery. Unlike small molecule drugs, proteins are typically unstable at interfaces where, on adsorption, they often denature and form aggregates, resulting in loss of efficacy and potential immunogenicity. This book covers both the fundamental aspects of proteins at interfaces and the quantification of interfacial behaviors of proteins. Importantly, this book introduces the industrial aspects of protein instabilities at interfaces, including the processes that introduce new interfaces, evaluation of interfacial instabilities, and mitigation strategies. The audience that this book targets encompasses scientists in the pharmaceutical and biotech industry, as well as faculty and students from academia in the surface science, pharmaceutical, and medicinal chemistry areas.
001434041 588__ $$aDescription based on print version record.
001434041 650_0 $$aDrug development.
001434041 650_0 $$aProteins$$xTherapeutic use.
001434041 650_0 $$aBiological interfaces.
001434041 650_6 $$aMédicaments$$xDéveloppement.
001434041 650_6 $$aProtéines$$xEmploi en thérapeutique.
001434041 650_6 $$aSurfaces (Biologie)
001434041 655_0 $$aElectronic books.
001434041 7001_ $$aLi, Jinjiang,$$eauthor.
001434041 7001_ $$aKrause, Mary E.,$$eauthor.
001434041 7001_ $$aTu, Raymond,$$eauthor.
001434041 77608 $$iPrint version:$$aLi, Jinjiang.$$tProtein Instability at Interfaces During Drug Product Development.$$dCham : Springer International Publishing AG, ©2021$$z9783030571764
001434041 830_0 $$aAAPS advances in the pharmaceutical sciences series ;$$vv. 43.
001434041 852__ $$bebk
001434041 85640 $$3Springer Nature$$uhttps://univsouthin.idm.oclc.org/login?url=https://link.springer.com/10.1007/978-3-030-57177-1$$zOnline Access$$91397441.1
001434041 909CO $$ooai:library.usi.edu:1434041$$pGLOBAL_SET
001434041 980__ $$aBIB
001434041 980__ $$aEBOOK
001434041 982__ $$aEbook
001434041 983__ $$aOnline
001434041 994__ $$a92$$bISE