Lyophilization of Biopharmaceuticals

2004
ISBN: 978-0-9711767-6-8
Verlag: AAPS Press

Buch, Englisch, Band II, 686 Seiten, Book, Format (B × H): 178 mm x 254 mm, Gewicht: 3220 g

Reihe: Biotechnology: Pharmaceutical Aspects

Humans have been experimenting with lyophilization, or freeze-drying, as a method to preserve biological structures for over a thousand years.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.

Zielgruppe

Research

Autoren/Hrsg.

Costantino, Henry R.

Pikal, Michael J.

Inhaltsverzeichnis

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.