MARC details
| 000 -CABECERA |
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| campo de control de longitud fija |
05564nam a22003495i 4500 |
| 001 - NÚMERO DE CONTROL |
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81191 |
| 003 - IDENTIFICADOR DEL NÚMERO DE CONTROL |
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ES-MaUEC |
| 005 - FECHA Y HORA DE LA ÚLTIMA TRANSACCIÓN |
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| 007 - CAMPO FIJO DE DESCRIPCIÓN FÍSICA--INFORMACIÓN GENERAL |
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| 008 - DATOS DE LONGITUD FIJA--INFORMACIÓN GENERAL |
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150519s2015 xxu| s |||| 0|eng d |
| 020 ## - NÚMERO INTERNACIONAL ESTÁNDAR DEL LIBRO |
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| Número Internacional Estándar del Libro |
9781493923830 |
| 024 7# - IDENTIFICADOR DE OTROS ESTÁNDARES |
|---|
| Número estándar o código |
10.1007/978-1-4939-2383-0 |
| Fuente del número o código |
doi |
| 040 ## - FUENTE DE LA CATALOGACIÓN |
|---|
| Centro/agencia modificador |
ES-MaUEC |
| 050 #4 - SIGNATURA TOPOGRÁFICA DE LA BIBLIOTECA DEL CONGRESO |
|---|
| Número de clasificación |
RS199.F74 |
| Número de documento/Ítem |
L967 2015 |
| 245 10 - MENCIÓN DE TÍTULO |
|---|
| Título |
Lyophilized Biologics and Vaccines : |
| Resto del título |
Modality-Based Approaches |
| Mención de responsabilidad, etc. |
edited by Dushyant Varshney, Manmohan Singh. |
| 260 ## - PUBLICACIÓN, DISTRIBUCIÓN, ETC. |
|---|
| Lugar de publicación, distribución, etc. |
New York |
| Nombre del editor, distribuidor, etc. |
Springer International Publishing |
| Fecha de publicación, distribución, etc. |
2015 |
| 300 ## - DESCRIPCIÓN FÍSICA |
|---|
| Extensión |
1 recurso en línea (XI, 401 p.) |
| Otras características físicas |
99 ilustraciones, 68 ilustraciones en color |
| 336 ## - TIPO DE CONTENIDO |
|---|
| Término de tipo de contenido |
Texto (visual) |
| 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 |
| 505 0# - NOTA DE CONTENIDO CON FORMATO |
|---|
| Nota de contenido con formato |
Preface -- Part I â€{u0339}ophilization History and Fundamentals -- History of Lyophilization -- Heterogeneity of protein environments in frozen solutions and in the dried state -- Advance understanding of buffer behavior during lyophilization -- Advances in Instrumental Analysis Applied to the Development of Lyophilization Cycles -- New Developments in Controlled Nucleation: Commercializing VERISEQ® Nucleation technology -- Part II â€{u0339}ophilized Biologics and Vaccines â€{u036F}dality Considerations -- Lyophilized Biologics -- Lyophilization of Therapeutic Proteins in Vials - Process Scale-up and Advances in Quality by Design -- Advances in Process Analytical Technology in Freeze Drying -- Process Scale-up and Optimization of Lyophilized Vaccine Products -- Stabilization of Plasmid DNA and Lipid-based Therapeutics as Dehydrated Formulations -- Part III â€{u0064}vances in Alternate Drying -- Alternatives to Vial Lyophilization -- Spray Drying of Biopharmaceuticals -- Current Trends and Advances in Bulk Crystallization and Freeze Drying of Biopharmaceuticals -- Case Studies and Examples of Biopharmaceutical Modalities -- Processed by Bulk Crystallization or Bulk Freeze Drying -- Part IVâ€{u04A5}gulatory, Packaging and Technology Transfer Considerations -- Lyophilization of Biologics - An FDA Perspective -- Recent Trends in Lyophilized Delivery Devices and Packaging -- Lyophilization Technology Transfer towards Product Launch. |
| 520 ## - SUMARIO, ETC. |
|---|
| Sumario, etc. |
This book provides a detailed account of the most recent developments, challenges and solutions to seamlessly advance and launch lyophilized biologics or vaccine products, based on diverse modalities, ranging from antibodies (e.g., monoclonal, fusion), complex biologics (e.g., antibody drug conjugates,ÂЅGylated proteins) and vaccines (e.g., recombinant protein based). The authors adeptly guide you through everything you need to know, from biophysical and chemical stability considerations of proteins, to critical assessment during process scale-up, technology transfer, packaging, alternate drying and device selection for a successful process validation, regulatory submission and launch of a stable, safe and effective product. Lyophilized Biologics and Vaccines: Modality-Based Approaches serves as a reference to all critical assessments and steps from early pre-formulation stages to product launch: Provides recent understanding of heterogeneity of protein environment in frozen systems, buffer stabilization, instrumental analysis and controlled ice nucleation technology Details product development strategies based on diverse modalities of biologics and vaccines, including plasmid DNA and lipid-based therapeutics Recent updates on quality-by-design and process analytical technology approaches, illustrated by case studies and FDA perspective Provides theÂ{uC874}est account of alternate drying technologies including spray drying and bulk freeze-drying Chapters are written by one or more world-renowned leading authorities from academia, industry or regulatory agencies, whose expertise cover lyophilization of the diverse modalities of biopharmaceuticals.Their contributions are based on the exhaustive review of literature coupled with excellent hands-on experiences in laboratory or GMP setup, making this an exceptional guide to all stages of lyophilized or dehydrated product development and commercial manufacturing. Âĵshyant B. Varshney, Ph.D., has made significant contributions in manufacturing science and technology, due diligence, tech transfer, product and process development (including lyophilization), quality-by-design and process analytical technologies for biologics, vaccinesÂ{u1BA4} small molecules. He is currently a Director of Manufacturing Assessment, MS&T at Hospira Inc. Â{u0361}nmohan Singh, Ph.D., is a well-known expert in the area of vaccine formulations and adjuvant research and has been working in vaccine R&D for the last 20 years. He is currently the Head of Global Drug Product Development at Novartis Vaccines and Diagnostics in Holly Springs, NC. |
| 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 |
| 700 1# - PUNTO DE ACCESO ADICIONAL--NOMBRE DE PERSONA |
|---|
| Nombre de persona |
Varshney, Dushyant |
| Término indicativo de función/relación |
editor literario |
| 9 (RLIN) |
93480 |
| Número de control del registro de autoridad o número normalizado |
Local |
| 700 1# - PUNTO DE ACCESO ADICIONAL--NOMBRE DE PERSONA |
|---|
| Nombre de persona |
Singh, Manmohan |
| Término indicativo de función/relación |
editor literario |
| 9 (RLIN) |
84623 |
| Número de control del registro de autoridad o número normalizado |
Local |
| 856 40 - LOCALIZACIÓN Y ACCESO ELECTRÓNICOS |
|---|
| Identificador Uniforme del Recurso |
https://go.openathens.net/redirector/universidadeuropea.es?url=https://link.springer.com/book/10.1007/978-1-4939-2383-0 |
| Nota pública |
Acceso a este recurso digital (usuarios Universidad Europea de Madrid) |
| 999 ## - NÚMEROS DE CONTROL DE SISTEMA (KOHA) |
|---|
| -- |
1 |
| 907 ## - TRANSACCIONES MILLENIUM |
|---|
| id bib interno millenium |
.b12897814 |
| fecha actualizac reg bib |
10-10-17 |
| fecha creacion reg bib |
18-01-16 |
| 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 |
| 945 ## - ITEM MILLENIUM |
|---|
| Signatura |
RS199.F74 L967 2015 EB |
| Número de copia |
1 |
| Código de barras |
eBOOK |
| Agencia |
0 |
| Localización del ejemplar (ubicación) |
mae |
| Código 2 (categoría) |
- |
| Precio |
EUR0.00 |
| Mensaje (popup en cliente staff) |
- |
| Mensaje (visible en OPAC) |
- |
| Estado |
b |
| Tipo de ejemplar |
15 |
| Total de préstamos |
0 |
| Total de renovaciones |
0 |
| Préstamos del año en curso |
0 |
| Préstamos del año anterior |
0 |
| Identificador de la copia de ejemplar en Millennium |
.i11567430 |
| Fecha de creación del ejemplar |
06-04-17 |
| 988 ## - NOTA LOCAL 598 |
|---|
| Nota local 598 |
EBSPRINGER |
| 998 ## - FONDO MILLENIUM |
|---|
| Biblioteca |
m |
| -- |
_alco |
| -- |
_vill |
| Fecha creación |
- - |
| Tipo de registro |
m |
| Tipo de materia |
z |
| e |
- |
| Idioma |
eng |
| País |
xxu |
| h |
0 |