Freeze-drying/lyophilization of pharmaceutical and biological products /
| Other Authors: | , |
|---|---|
| Format: | Book |
| Language: | English |
| Published: |
New York :
Marcel Dekker,
[2004]
|
| Edition: | Second edition. |
| Series: | Drugs and the pharmaceutical sciences ;
137. |
| Subjects: |
Table of Contents:
- Glimpses into the realm of freeze-drying : fundamental issues
- Structural and dynamic properties of bulk and confined water
- Mechanisms of protein stabilization during freeze-drying and storage : the relative importance of thermodynamic stabilization and glassy state relaxation dynamics
- Freezing and annealing phenomena in lyophilization
- Freezing- and drying-induced perturbations of protein structure and mechanisms of protein protection by stabilizing additives
- Molecular mobility of freeze-dried formulations as determined by NMR relaxation, and its effect on storage stability
- Formulation characterization
- Practical aspects of freeze-drying of pharmaceutical and biological products using non-aqueous co-solvent systems
- Closure and container considerations in lyophilization
- Advanced glassware for freeze-drying
- Critical steps in the preparation of elastomeric closures for biopharmaceutical freeze-dried products
- Development of a new concept for bulk freeze-drying : LYOGUARD® freeze-dry packaging
- Regulatory control of freeze-dried products : importance and evaluation of residual moisture
- Freeze-drying of biological standards
- Industrial freeze-drying for pharmaceutical applications
- Development of process data in a pilot plant transferable to production
- Technical procedures for operation of cleaning-in-place/sterilization-in-place process for production freeze-drying equipment
- Global validation of freeze-drying cycle parameters by using integral HFT systems
- Lyophilizer qualification : some practical advice
- Lyophilizer process validation
- A new development : irradiation of freeze-dried vaccine and other select biological products
- Some leading edge prospects in lyophilization