Lyophilized Biologics and Vaccines : Modality-Based Approaches /

Detalles Bibliográficos
Autor Corporativo: SpringerLink (Online service)
Otros Autores: Varshney, Dushyant. (Editor ), Singh, Manmohan. (Editor )
Formato: eBook
Lenguaje:English
Publicado: New York, NY : Springer New York : Imprint: Springer, 2015.
Edición:1st ed. 2015.
Materias:
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020 |a 9781493923830 
024 7 |a 10.1007/978-1-4939-2383-0  |2 doi 
040 |a Sistema de Bibliotecas del Tecnológico de Costa Rica 
245 1 0 |a Lyophilized Biologics and Vaccines :  |b Modality-Based Approaches /  |c edited by Dushyant Varshney, Manmohan Singh. 
250 |a 1st ed. 2015. 
260 # # |a New York, NY :  |b Springer New York :  |b Imprint: Springer,  |c 2015. 
300 |a XI, 401 p. 99 illus., 68 illus. in color. :  |b online resource. 
336 |a text  |b txt  |2 rdacontent 
337 |a computer  |b c  |2 rdamedia 
338 |a online resource  |b cr  |2 rdacarrier 
505 0 |a Preface -- Part I - Lyophilization 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 - Lyophilized Biologics and Vaccines - Modality 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 - Advances 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 IV- Regulatory, 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. 
650 0 |a Vaccines. 
650 0 |a Antibodies. 
650 0 |a Pharmaceutical technology. 
650 1 4 |a Vaccine. 
650 2 4 |a Antibodies. 
650 2 4 |a Pharmaceutical Sciences/Technology. 
700 1 |a Varshney, Dushyant.  |e editor. 
700 1 |a Singh, Manmohan.  |e editor. 
710 2 |a SpringerLink (Online service) 
773 0 |t Springer eBooks