Lyophilization of Biopharmaceuticals
Henry R. Costantino, Michael J. Pikal
Springer Science & Business Media, 2005年12月5日
目录
Lyophilization Equipment
Validation of Lyophilization Equipment and Process
Heat and Mass Transfer Issues in Freezedrying Process Development
Process and Formulation development and Product Characterization
Freezedrying Process Development for Protein Pharmaceuticals
Excipients for Use in Lyophilized Pharmaceutical Peptide Protein and other Bioproducts
The Role of Water in Physical Transformations in Freezedried Products
Thermal Analysis of Lyophilized Pharmaceutical Peptide and Protein Formulations
Physical Damage to Proteins During Freezing Drying and Rehydration
Degradation Pathways for Lyophillzed Peptides and Proteins
Nontraditional Freezedrying Applications
Stabilization of Lyophilized Proteins Encapsulated in Controlledrelease Polymers Overview and Case Studies Including Formaldehydetreated Vaccine...
Spray Freezedrying of Biopharmaceuticals Applications and Stability Considerations
Freezedrying of Liposomes A Critical Review of Mechanisms Involved in Lyoprotection and Solidstate Stability
Physical Stabilization of Plasmid DNAbased Therapeutics During Freezing and Drying
Dehydrated Protein Powders as Biocatalysts in Nonaqueous Solvents
Microscopy of Lyophilized Proteins
Physical Properties and Product Stability
Thermodynamics and Dynamics of Glassforming Systems