Lyophilization of Pharmaceuticals and Biologicals New Technologies and Approaches 1st Edition by Kevin Ward, Paul Matejtschuk ISBN 9781493989287 149398928X

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Product details:
ISBN 10: 149398928X
ISBN 13: 9781493989287
Author: Kevin Ward, Paul Matejtschuk

This detailed volume brings together leading practitioners in the freeze-drying community to address recent progress, not only in new analytical tools and applications of the data derived in cycle design but also in the manufacturing of lyophilized products in the healthcare sector – whether these be therapeutics, vaccines or diagnostic products – and indeed the equipment to deliver this scale of freeze-drying. Areas of focus include analytical and formulation issues, process monitoring and control, as well as post-lyophilization analysis. Written for the Methods in Pharmacology and Toxicology series, chapters include the type of expert advice that leads to superior results in the lab. 

Authoritative and practical, Lyophilization of Pharmaceuticals and Biologicals: New Technologies and Approaches serves as an ideal guide for researchers working in or just seeking an update on this rapidly changing field.

 Lyophilization of Pharmaceuticals and Biologicals New Technologies and Approaches 1st Edition Table of contents:

Chapter 1: Introduction to Lyophilization

• Definition and Principles of Lyophilization
• History and Evolution of Freeze-Drying Technology
• Applications of Lyophilization in Pharmaceuticals and Biologicals
• Key Benefits and Challenges of Lyophilization

Chapter 2: Fundamentals of Lyophilization Process

• Stages of Lyophilization: Freezing, Primary Drying, and Secondary Drying
• Physical and Chemical Processes During Freeze-Drying
• Thermodynamics and Heat Transfer in Lyophilization
• The Role of Ice Nucleation and Crystallization

Chapter 3: Lyophilization of Pharmaceutical Products

• Lyophilization of Small Molecule Drugs
• Challenges in Formulating Drugs for Freeze-Drying
• Impact of Lyophilization on Drug Stability and Bioavailability
• Process Optimization for Pharmaceutical Lyophilization

Chapter 4: Lyophilization of Biologicals

• Lyophilization of Proteins, Peptides, and Antibodies
• Stability Considerations in Lyophilizing Biologicals
• Lyophilization of Vaccines and Enzyme Products
• Impact on Biological Activity and Immunogenicity

Chapter 5: Formulation Development for Lyophilization

• Excipient Selection for Freeze-Drying Formulations
• Stabilizing Agents: Sugars, Polymers, and Amino Acids
• Formulation Strategies for Enhancing Stability
• Case Studies of Lyophilized Pharmaceutical Formulations

Chapter 6: Advances in Lyophilization Technology

• Freeze-Drying Equipment and Technologies
• Advances in Lyophilization Cycle Design and Control
• Continuous and Semi-Continuous Lyophilization Systems
• Innovations in Freeze-Drying for Large-Scale Production

Chapter 7: Analytical Techniques for Lyophilized Products

• Characterization of Lyophilized Products: Morphology and Physical Properties
• Analytical Methods: DSC, FTIR, NMR, and X-ray Diffraction
• Measuring Residual Moisture Content and Its Impact on Stability
• Assessing Product Quality and Integrity in Lyophilized Forms

Chapter 8: Stability and Shelf Life of Lyophilized Products

• Factors Affecting Stability of Lyophilized Pharmaceuticals and Biologicals
• Shelf Life Studies and Accelerated Testing for Lyophilized Products
• Packaging Considerations for Long-Term Storage
• Role of Lyophilization in Extending Shelf Life and Stability

Chapter 9: Regulatory Considerations and Standards

• Regulatory Guidelines for Lyophilized Products: FDA, EMA, ICH
• Good Manufacturing Practices (GMP) for Lyophilization
• Quality Control and Documentation Requirements
• Risk Management and Validation in Lyophilization

Chapter 10: Process Scale-Up and Commercialization

• Scaling Up the Lyophilization Process from Laboratory to Industrial Scale
• Challenges in Large-Scale Freeze-Drying Operations
• Technology Transfer and Process Validation
• Case Studies in the Commercialization of Lyophilized Drugs and Biologicals

Chapter 11: Lyophilization for Biopharmaceuticals: Emerging Trends

• Personalized Medicine and Lyophilization of Custom Biological Products
• Lyophilization of Cell-Based Therapies and Gene Therapy Products
• Advances in Lyophilization of RNA-based Therapeutics (e.g., mRNA Vaccines)
• Future Prospects and Innovations in Biopharmaceutical Freeze-Drying

Chapter 12: Future Directions in Lyophilization Research

• Next-Generation Lyophilization Technologies
• The Role of Artificial Intelligence and Machine Learning in Lyophilization Optimization
• New Materials and Techniques for Enhanced Stability and Efficiency
• Vision for the Future of Lyophilization in Drug Development

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