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150519s2015 xxu| s |||| 0|eng d |
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|a 9781493923830
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| 024 |
7 |
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|a 10.1007/978-1-4939-2383-0
|2 doi
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| 040 |
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|a Sistema de Bibliotecas del Tecnológico de Costa Rica
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| 245 |
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|a Lyophilized Biologics and Vaccines :
|b Modality-Based Approaches /
|c edited by Dushyant Varshney, Manmohan Singh.
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| 250 |
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|a 1st ed. 2015.
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| 260 |
# |
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|a New York, NY :
|b Springer New York :
|b Imprint: Springer,
|c 2015.
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| 300 |
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|a XI, 401 p. 99 illus., 68 illus. in color. :
|b online resource.
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| 336 |
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|a text
|b txt
|2 rdacontent
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| 337 |
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|a computer
|b c
|2 rdamedia
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| 338 |
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|a online resource
|b cr
|2 rdacarrier
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|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.
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| 650 |
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|a Vaccines.
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| 650 |
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|a Antibodies.
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| 650 |
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|a Pharmaceutical technology.
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| 650 |
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4 |
|a Vaccine.
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| 650 |
2 |
4 |
|a Antibodies.
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| 650 |
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4 |
|a Pharmaceutical Sciences/Technology.
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| 700 |
1 |
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|a Varshney, Dushyant.
|e editor.
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| 700 |
1 |
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|a Singh, Manmohan.
|e editor.
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| 710 |
2 |
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|a SpringerLink (Online service)
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| 773 |
0 |
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|t Springer eBooks
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