MARC details
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05259nam a2200337 i 4500 |
| 001 - NÚMERO DE CONTROL |
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399358 |
| 003 - IDENTIFICADOR DEL NÚMERO DE CONTROL |
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ES-MaUEC |
| 005 - FECHA Y HORA DE LA ÚLTIMA TRANSACCIÓN |
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20240415170252.0 |
| 006 - CÓDIGOS DE INFORMACIÓN DE LONGITUD FIJA--CARACTERÍSTICAS DEL MATERIAL ADICIONAL |
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230424s2023 sz | fo |||| 0|eng d |
| 020 ## - NÚMERO INTERNACIONAL ESTÁNDAR DEL LIBRO |
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| Número Internacional Estándar del Libro |
9783031126345 |
| 024 7# - IDENTIFICADOR DE OTROS ESTÁNDARES |
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| Número estándar o código |
10.1007/978-3-031-12634-5 |
| Fuente del número o código |
doi |
| 040 ## - FUENTE DE LA CATALOGACIÓN |
|---|
| Centro catalogador/agencia de origen |
ES-MaUEC |
| Lengua de catalogación |
spa |
| Centro/agencia transcriptor |
ES-MaUEC |
| Centro/agencia modificador |
ES-MaUEC |
| 050 #4 - SIGNATURA TOPOGRÁFICA DE LA BIBLIOTECA DEL CONGRESO |
|---|
| Número de clasificación |
RS192 |
| Número de documento/Ítem |
2023 EB |
| 245 00 - MENCIÓN DE TÍTULO |
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| Título |
Principles and Practices of Lyophilization in Product Development and Manufacturing |
| Mención de responsabilidad, etc. |
edited by Feroz Jameel |
| 250 ## - MENCIÓN DE EDICIÓN |
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| Mención de edición |
1st ed. 2023 |
| 264 #1 - PRODUCCIÓN, PUBLICACIÓN, DISTRIBUCIÓN, FABRICACIÓN Y COPYRIGHT |
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| Producción, publicación, distribución, fabricación y copyright |
Cham |
| Nombre del de productor, editor, distribuidor, fabricante |
Springer International Publishing |
| Fecha de producción, publicación, distribución, fabricación o copyright |
2023 |
| 300 ## - DESCRIPCIÓN FÍSICA |
|---|
| Extensión |
1 recurso en línea |
| 336 ## - TIPO DE CONTENIDO |
|---|
| Término de tipo de contenido |
texto |
| Código de tipo de contenido |
txt |
| Fuente |
rdacontent |
| 337 ## - TIPO DE MEDIO |
|---|
| Nombre/término del tipo de medio |
electrónico |
| Código del tipo de medio |
c |
| Fuente |
rdamedia |
| 338 ## - TIPO DE SOPORTE |
|---|
| Nombre/término del tipo de soporte |
recurso electrónico |
| Código del tipo de soporte |
cr |
| Fuente |
rdacarrier |
| 490 0# - MENCIÓN DE SERIE |
|---|
| Mención de serie |
AAPS Advances in the Pharmaceutical Sciences Series |
| Número Internacional Normalizado para Publicaciones Seriadas |
2210-738X |
| Designación de volumen o secuencia |
59 |
| 505 0# - NOTA DE CONTENIDO CON FORMATO |
|---|
| Nota de contenido con formato |
Overview 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 ## - SUMARIO, ETC. |
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| Sumario, etc. |
The 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 ## - NOTA LOCAL 598 |
|---|
| Nota local 598 (boletines) |
Springer_BiomedLife_2023 |
| 650 #7 - PUNTO DE ACCESO ADICIONAL DE MATERIA--TÉRMINO DE MATERIA |
|---|
| Fuente del encabezamiento o término |
embne |
| 9 (RLIN) |
161127 |
| Término de materia o nombre geográfico como elemento de entrada |
Tecnología farmacéutica |
| 856 40 - LOCALIZACIÓN Y ACCESO ELECTRÓNICOS |
|---|
| Identificador Uniforme del Recurso |
https://go.openathens.net/redirector/universidadeuropea.es?url=https://doi.org/10.1007/978-3-031-12634-5 |
| Nota pública |
Acceso a este recurso digital (usuarios Universidad Europea de Madrid) |
| 942 ## - ELEMENTOS DE PUNTO DE ACCESO ADICIONAL (KOHA) |
|---|
| Fuente del sistema de clasificación o colocación |
Library of Congress Classification |
| Tipo de ítem Koha |
LIBRO-E NO PRÉSTAMO |
| 998 ## - DATOS ESTADÍSTICOS |
|---|
| Fecha de catalogación |
04/2024 |
| Tipo de materia |
E-book |
| Catalogador |
Isabel Alonso |
| Catalogado |
Sí |