Lyophilized Biologics and Vaccines : Modality-Based Approaches /
| Autor Corporativo: | |
|---|---|
| Otros Autores: | , |
| Formato: | eBook |
| Lenguaje: | English |
| Publicado: |
New York, NY :
Springer New York : Imprint: Springer,
2015.
|
| Edición: | 1st ed. 2015. |
| Materias: |
Tabla de Contenidos:
- 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.