001463544 000__ 06300cam\a22006137i\4500
001463544 001__ 1463544
001463544 003__ OCoLC
001463544 005__ 20230601003325.0
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001463544 007__ cr\cn\nnnunnun
001463544 008__ 230428s2023\\\\sz\\\\\\o\\\\\001\0\eng\d
001463544 019__ $$a1377816811
001463544 020__ $$a9783031126345$$q(electronic bk.)
001463544 020__ $$a3031126343$$q(electronic bk.)
001463544 020__ $$z3031126335
001463544 020__ $$z9783031126338
001463544 0247_ $$a10.1007/978-3-031-12634-5$$2doi
001463544 035__ $$aSP(OCoLC)1377621854
001463544 040__ $$aYDX$$beng$$erda$$cYDX$$dGW5XE$$dEBLCP$$dYDX
001463544 049__ $$aISEA
001463544 050_4 $$aRS199.F74$$bP75 2023
001463544 08204 $$a615.1/9$$223/eng/20230504
001463544 24500 $$aPrinciples and practice of the lyophilization process and product development /$$cFeroz Jameel, editor.
001463544 264_1 $$aCham, Switzerland :$$bSpringer,$$c[2023]
001463544 300__ $$a1 online resource
001463544 336__ $$atext$$btxt$$2rdacontent
001463544 337__ $$acomputer$$bc$$2rdamedia
001463544 338__ $$aonline resource$$bcr$$2rdacarrier
001463544 4901_ $$aAAPS Advances in the Pharmaceutical Sciences Series
001463544 500__ $$aIncludes index.
001463544 5050_ $$aOverview of Freeze Drying -- Characterization and Determination of Freeze Drying Properties of Frozen Formulations Case Studies -- Beyond pH: Acid/base relationships in frozen and freeze-dried pharmaceuticals -- Concepts and Strategies in the Design of Formulation for Freeze Drying -- Formulation Design for Freeze Drying - Case studies of Stabilization of Proteins -- Challenges and Considerations in the Development of a High Protein Concentration Lyophilized Drug Product -- Freeze-drying of thermosensible pharmaceuticals with organic co-solvent + water formulations -- Primary container closure system selection for lyophilized drug products -- Vial Breakage During Lyophilization -- The Nucleation of Ice -- Stresses, Stabilization, and Recent Insights in Freezing of Biologics -- Lyophilization Process Understanding and Scale-up using ab initio Vial Heat Transfer Modeling -- Secondary drying: Challenges and Considerations -- Design and Process Considerations in Spray Freeze Drying -- LyoPRONTO: Deterministic and Probabilistic Modeling. Tutorial and Case Study -- Utilizing Solid-State NMR Spectroscopy to Assess Properties of Lyophilized Formulations -- Design of Moisture Studies for a Lyophilized Product -- Laser-Based Headspace Moisture Analysis for Rapid Nondestructive Moisture Determination of Lyophilized Products -- Application of PAT in Real-time Monitoring and Controlling of Lyophilization Process -- Process Analytical Technology (PAT) for Lyophilization Process Monitoring and End Point Detection -- Advances in Process Analytical Technology A Small Scale Freeze-Dryer for Process Analysis, Optimization, and Transfer -- Overview of Heat and Mass Transfer Modeling in Lyophilization to Create Design Spaces and Improve Process Analytical Tool (PAT) Capability -- Application of QbD elements in the Development and Manufacturing of a Lyophilized product -- Characterization of Freeze Dryer -- Scale-up and Technology Transfer of a Lyophilization Process -- Lyophilization Validation: Process Design and Modeling -- Lyophilization Validation: Process Qualification and Continued Process Verification -- Homogeneity Assessment of Lyohilized Biological Drug Products During Process Performance Qualification -- Informed Manufacturing through the use of Big Data Analytics for Freeze Drying Process & Equipment -- Multivariate Analysis for Process Understanding, Continuous Process Verification and Condition Monitoring of Lyophilization Processes -- Lyophilized Drug Product Cake Appearance: What Is Acceptable?.
001463544 506__ $$aAccess limited to authorized users.
001463544 520__ $$aThe biotechnology/biopharmaceutical sector has tremendously grown which led to the invention of engineered antibodies such as Antibody Drug Conjugates (ADCs), Bispecific T cell engager ( BITES), Dual Variable Domain ( DVD), Chimeric Antigen Receptor - Modified Tcells (CART) that are currently being used as therapeutic agents for immunology and oncology disease conditions. In addition to other pharmaceuticals and biopharmaceuticals, all these novel formats are fragile with respect to their stability/structure under processing conditions meaning marginal stability in the liquid state and often require lyophilization to enhance their stability and shelf-life. This book contains chapters/topics that will describe every aspect of the lyophilization process and product development and manufacturing, starting from the overview of lyophilization process, equipment required, characterization of the material, design and development of the formulation and lyophilization process, various techniques for characterization of the product, scale-up/tech-transfer and validation. It also describes the application of CFD coupled with mathematical modeling in the lyophilization process and product development, scale-up, and manufacturing. Additionally, Principles and Practice of Lyophilization Process and Product Development contains an entire dedicated section on Preservation of Biologicals comprised of nine chapters written by experts and including case studies.
001463544 588__ $$aOnline resource; title from PDF title page (SpringerLink, viewed May 4, 2023).
001463544 650_0 $$aFreeze-drying.
001463544 650_0 $$aDrug development.
001463544 655_0 $$aElectronic books.
001463544 7001_ $$aJameel, Feroz,$$eeditor.
001463544 77608 $$iPrint version: $$z3031126335$$z9783031126338$$w(OCoLC)1333266347
001463544 830_0 $$aAAPS advances in the pharmaceutical sciences series.
001463544 852__ $$bebk
001463544 85640 $$3Springer Nature$$uhttps://univsouthin.idm.oclc.org/login?url=https://link.springer.com/10.1007/978-3-031-12634-5$$zOnline Access$$91397441.1
001463544 909CO $$ooai:library.usi.edu:1463544$$pGLOBAL_SET
001463544 980__ $$aBIB
001463544 980__ $$aEBOOK
001463544 982__ $$aEbook
001463544 983__ $$aOnline
001463544 994__ $$a92$$bISE