Lyophilization of biopharmaceuticals (Biotechnology, pharmaceutical aspects, volume 2)

Humans have been experimenting with lyophilization, or freeze-drying, as a method to preserve biological structures for over a thousand year. These early efforts focused on food. In recent times, freeze-drying has advanced to the point where it is a common practice for biopharmaceuticals, including blood plasma and vaccines. Lyophilization is still a method of choice for preservation of the growing list of biopharmaceutical products. This comprehensive volume, intended for scientists in both academia and industry, covers a wide range of topics relevant to the formulation of peptide and protein drugs in the freeze-dried state.

Lyophilization Equipment.- Validation of Lyophilization.- Heat and Mass Transfer in Freeze-drying Process Development.- Freeze-drying Process Development for Protein Pharmaceuticals.- Excipients for Use in Lyophilized Pharmaceutical Peptide, Protein, and other Bioproducts.- The Role of Water in Physical Transformations in Freeze-dried Products.- Thermal Analysis of Lyophilized Pharmaceutical Peptide and Protein Formulations.- Microscopy of Lyophilized Proteins.- Thermodynamics and Dynamics of Glassforming Systems.- Physical Damage to Proteins During Freezing, Drying and Rehydration.- Degradation Pathways for Lyophilized Peptides and Proteins.- Stabilization of Lyophilized Proteins Encapsulated in Controlled-release Polymers.- Spray Freeze-drying of Biopharmaceuticals.- Freeze-drying of Liposomes.- Physical Stabilization of Plasmid DNA-based Therapeutics During Freezing and Drying.- Dehydrated Protein Powders as Biocatalysts in Nonaqueous Solvents.

Gives an indepth explaination of a wide range of topics related to the formulation of peptide and protein drugs in the freeze-dried state