Lyophilization of Pharmaceuticals and Biologicals : New Technologies and Approaches /

Detalles Bibliográficos
Autor Corporativo: SpringerLink (Online service)
Otros Autores: Ward, Kevin R. (Editor ), Matejtschuk, Paul. (Editor )
Formato: eBook
Lenguaje:English
Publicado: New York, NY : Springer New York : Imprint: Humana, 2019.
Edición:1st ed. 2019.
Colección:Methods in Pharmacology and Toxicology,
Materias:
Tabla de Contenidos:
  • Characterization of Formulations for Freeze Drying
  • Formulation and Process Development for Lyophilized Biological Reference Materials
  • Controlled Ice Nucleation Using ControLyo® Pressurization-Depressurization Method
  • Alternative Methods of Controlling Nucleation in Freeze Drying
  • Tunable Diode Laser Absorption Spectroscopy in Lyophilization
  • Containment Options for the Freeze-Drying of Biological Entities and Potent Materials
  • Freeze Drying Systems: Freeze Dryer Design Requirements & Automatic Loading and Unloading Systems (ALUS™)
  • Regulatory Aspects of Freeze Drying
  • Container and Reconstitution Systems for Lyophilized Drug Products
  • Scale-Up of Freeze-Drying Cycles, the Use of Process Analytical Technology (PAT) and Statistical Analysis
  • Through Vial Impedance Spectroscopy (TVIS): A Novel Approach to Process Understanding for Freeze-Drying Cycle Development
  • Lyophilization of High-Concentration Protein Formulations
  • Mechanical Behavior and Structure of Freeze Dried Cakes
  • High Resolution Mass Spectrometric Methods for Proteins in Lyophilized Solids.