000			05259nam a2200337 i 4500
999			_c399358 _d399358
001			399358
003			ES-MaUEC
005			20240415170252.0
006			a||||fo|||| 00| 0
007			cr nn 008mamaa
008			230424s2023 sz | fo |||| 0|eng d
020			_a9783031126345
024	7		_a10.1007/978-3-031-12634-5 _2doi
040			_aES-MaUEC _bspa _cES-MaUEC _dES-MaUEC
050		4	_aRS192 _b2023 EB
245	0	0	_aPrinciples and Practices of Lyophilization in Product Development and Manufacturing _cedited by Feroz Jameel
250			_a1st ed. 2023
264		1	_aCham _bSpringer International Publishing _c2023
300			_a1 recurso en línea
336			_atexto _btxt _2rdacontent
337			_aelectrónico _bc _2rdamedia
338			_arecurso electrónico _bcr _2rdacarrier
490	0		_aAAPS Advances in the Pharmaceutical Sciences Series _x2210-738X _v59
505	0		_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?.
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.
988			_aSpringer_BiomedLife_2023
650		7	_2embne _9161127 _aTecnología farmacéutica
856	4	0	_uhttps://go.openathens.net/redirector/universidadeuropea.es?url=https://doi.org/10.1007/978-3-031-12634-5 _zAcceso a este recurso digital (usuarios Universidad Europea de Madrid)
942			_2lcc _cLE
998			_b04/2024 _dz _eb _zSI