Lyophilization is still a method of choice for preservation of the growing list of biopharmaceutical products. Lyophilization of Biopharmaceuticals covers a wide range of topics relevant to the formulation of peptide and protein drugs in the freeze-dried state.

Contents

Part 1: Freeze Dryers and the Fundamentals of Heat and Mass Transfer

1. Lyophilization Equipment
2. Validation of Lyophilization: Equipment and Process
3. Heat and Mass Transfer in Freeze-drying Process Development

Part 2: Process and Formulation Development and Product Characterization

4. Freeze-drying Process Development for Protein Pharmaceuticals
5. Excipients for Use in Lyophilized Pharmaceutical Peptide, Protein, and other Bioproducts
6. The Role of Water in Physical Transformations in Freeze-dried Products
7. Thermal Analysis of Lyophilized Pharmaceutical Peptide and Protein Formulations
8. Microscopy of Lyophilized Proteins

Part 3: Physical Properties and Product Stability

9. Thermodynamics and Dynamics of Glassforming Systems
10. Physical Damage to Proteins During Freezing, Drying and Rehydration
11. Degradation Pathways for Lyophilized Peptides and Proteins

Part 4: Non-traditional Freeze-drying Applications

12. Stabilization of Lyophilized Proteins Encapsulated in Controlled-release Polymers
13. Spray Freeze-drying of Biopharmaceuticals
14. Freeze-drying of Liposomes
15. Physical Stabilization of Plasmid DNA-based Therapeutics During Freezing and Drying
16. Dehydrated Protein Powders as Biocatalysts in Nonaqueous Solvents

Index

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