Principles and Practices of Lyophilization in Product Development and Manufacturing
The biotechnology/biopharmaceutical sector has tremendously grown which led to the invention of engineered antibodies such as Antibody Drug Conjugates (ADCs), Bispecific T cell engager ( BITES), Dual Variable Domain ( DVD), Chimeric Antigen Receptor - Modified Tcells (CART) that are currently being...
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| Format: | Elektronisch E-Book |
| Sprache: | Englisch |
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Springer International Publishing : Imprint: Springer,
2023.
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| Ausgabe: | 1st ed. 2023. |
| Schriftenreihe: | AAPS Advances in the Pharmaceutical Sciences Series,
59 |
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| Online-Zugang: | https://doi.org/10.1007/978-3-031-12634-5 |
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Inhaltsangabe:
- Overview of Freeze Drying
- Characterization and Determination of Freeze Drying Properties of Frozen Formulations – Case Studies
- Beyond pH: Acid/base relationships in frozen and freeze-dried pharmaceuticals
- Concepts and Strategies in the Design of Formulation for Freeze Drying
- Formulation Design for Freeze Drying - Case studies of Stabilization of Proteins
- Challenges and Considerations in the Development of a High Protein Concentration Lyophilized Drug Product
- Freeze-drying of thermosensible pharmaceuticals with organic co-solvent + water formulations
- Primary container closure system selection for lyophilized drug products
- Vial Breakage During Lyophilization
- The Nucleation of Ice
- Stresses, Stabilization, and Recent Insights in Freezing of Biologics
- Lyophilization Process Understanding and Scale-up using ab initio Vial Heat Transfer Modeling
- Secondary drying: Challenges and Considerations
- Design and Process Considerationsin Spray Freeze Drying
- LyoPRONTO: Deterministic and Probabilistic Modeling. Tutorial and Case Study
- Utilizing Solid-State NMR Spectroscopy to Assess Properties of Lyophilized Formulations
- Design of Moisture Studies for a Lyophilized Product
- Laser-Based Headspace Moisture Analysis for Rapid Nondestructive Moisture Determination of Lyophilized Products
- Application of PAT in Real-time Monitoring and Controlling of Lyophilization Process
- Process Analytical Technology (PAT) for Lyophilization Process Monitoring and End Point Detection
- Advances in Process Analytical Technology – A Small Scale Freeze-Dryer for Process Analysis, Optimization, and Transfer
- Overview of Heat and Mass Transfer Modeling in Lyophilization to Create Design Spaces and Improve Process Analytical Tool (PAT) Capability
- Application of QbD elements in the Development and Manufacturing of a Lyophilized product
- Characterization of Freeze Dryer
- Scale-up and Technology Transfer of a Lyophilization Process
- Lyophilization Validation: Process Design and Modeling
- Lyophilization Validation: Process Qualification and Continued Process Verification
- Homogeneity Assessment of Lyohilized Biological Drug Products During Process Performance Qualification
- Informed Manufacturing through the use of Big Data Analytics for Freeze Drying Process & Equipment
- Multivariate Analysis for Process Understanding, Continuous Process Verification and Condition Monitoring of Lyophilization Processes
- Lyophilized Drug Product Cake Appearance: What Is Acceptable?.