Lyophilized Biologics and Vaccines Modality-Based Approaches /

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 conjugat...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor Corporativo: SpringerLink (Online service)
Otros Autores: Varshney, Dushyant (Editor ), Singh, Manmohan (Editor )
Formato: Electrónico eBook
Idioma:Inglés
Publicado: New York, NY : Springer New York : Imprint: Springer, 2015.
Edición:1st ed. 2015.
Temas:
Pharmacology.
Immunospecificity.
Pharmaceutical chemistry.
Adaptive Immunity.
Pharmaceutics.
Acceso en línea:Texto Completo
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.

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