Development and Manufacture of Protein Pharmaceuticals focuses on the development, manufacture, and commercialization of pharmaceutical protein dosage forms, and emphasizes GMP attributes of quality, safety, purity, and strength.

No other book on protein goes into such practical detail on the requirements, and how to meet them, for developing, manufacturing, and gaining regulatory approval of protein dosage forms.

Contents

Preformulation Studies as an Essential Guide to Formulation Development and Manufacture of Protein Pharmaceuticals

• Introduction
• Protein Structural Characterization and Conformational Stability
• Protein Size, Quaternary Structure, Aggregation State, and Solubility
• Degradative Covalent Reactions and Their First Effect on Physicochemical and Biological Properties of Proteins
• Conclusions

Formulation Development of Protein Dosage Forms

• Introduction
• Why Proteins Present Unique Challenges to the Development Scientist
• General Formulation Principles for Proteins
• Why Packaging, Processing, and Formulation are Interrelated
• Commercially Available Protein Dosage Forms
• Chemical Stabilization
• Physical Stabilization
• Formulation Approaches for Solving Physical Stability Problems
• Additives for Antimicrobial Preservation
• Other Additives
• Packaging
• Interface between Formulation Development and Manufacturing
• Quality Considerations during Formulation Development
• Examples of Formulation Problems

Aseptic Processing of Protein Pharmaceuticals

• Introduction
• Aseptic Processing of Solution, Lyophilized, and Suspension Dosage Forms
• Unique Challenges in the Aseptic Processing of Protein Pharmaceuticals
• Developing Aseptic Processes for Drug Product Manufacturing
• Conceptual Framework for Drug Product ProcessValidation

Fundamentals of Thermal Sterilization Processes

• Introduction
• Effects of Heat on Living Cells
• Factors Affecting Resistance of Microorganisms to Thermal Inactivation
• Thermal Inactivation of Microorganisms
• Sterility Assurance
• Thermal Inactivation Kinetics
• Sterilization Cycle Development
• Sterilization Engineering
• Parametric Release of Terminally Sterilized Drug Products
• Summary

Membrane Filtration

• Introduction
• Overview of Filtration Membranes
• Membrane Filtration Theory
• The Practice of Sterile Filtration

Fundamentals of Freeze-Drying

• Introduction
• Overview of the Freeze-Drying Process
• The Freezing Process
• Material Characterization
• The Drying Process
• Stability of Freeze-Dried Formulations
• Summary

Quality Assurance and Quality Control for Biopharmaceutical Products

• Introduction
• Defining Quality Assurance and Quality Control in Biopharmaceutical Companies
• Involvement of Quality in Biopharmaceutical Manufacturing Control
• Overall Quality Control Strategy for Biopharmaceutical Products
• Closing Comments on Quality in Biopharmaceutical Companies

Regulatory Considerations in the Development of Protein Pharmaceuticals

• Introduction
• Biotechnology Product Development
• Production Variables
• Manufacturing Process Issues
• Product Quality Attributes
• Evolution of the New Regulatory Paradigm

Index

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