Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals is a real-world guide to the production and manufacturing of biopharmaceuticals.

This book examines all areas of biopharmaceuticals manufacturing, from development and formulation to production and packaging. It focuses on real-world methods for maintaining product integrity throughout the commercialization process, clearly explaining the fundamentals and essential pathways for all development stages.

Coverage includes:

• Research and early development phase–appropriate approaches for ensuring product stability
• Development of commercially viable formulations for liquid and lyophilized dosage forms
• Optimal storage, packaging, and shipping methods
• Case studies relating to therapeutic monoclonal antibodies, recombinant proteins, and plasma fractions
• Useful analysis of successful and failed products

Contents

Part I Preformulation and Development of Stability Indicating Assays: Biophysical Characterization Techniques

1. The Structure of Biological Therapeutics
2. Chemical Instability in Peptide and Protein Pharmaceuticals
3. Physical Instability in Peptide and Protein Pharmaceuticals
4. Immunogenicity of Therapeutic Proteins
5. Preformulation Research: Assessing Protein Solution Behavior Early During Therapeutic Development
6. Formulation Development of Phase I/II Biopharmaceuticals: An Efficient and Timely Approach
7. Late Stage Formulation Development and Characterization of Biopharmaceuticals
8. An Empirical Phase Diagram/ High Throughput Screening Approach to the Characterization and Formulation of Biopharmaceuticals
9. Fluorescence and Phosphorescence Methods to Probe Protein Structure and Stability in Ice: the Case of Azurin
10. Applications of Sedimentation Velocity Analytical Ultracentrifugation
11. Field Flow Fractionation with Multi-angle Light Scattering for Measuring Particle Size of Virus-like Particles
12. Light Scattering Techniques and their Application to Formulation and Aggregation Concerns

Part 2 Development of a Formulation for Liquid Dosage Form

13. Efficient Approaches to Formulation Development of Biopharmaceuticals
14. Prediction of Protein Aggregation Propensities from Primary Sequence Information
15. High Concentration Antibody Formulations
16. Development of Formulations for Therapeutic Monoclonal Antibodies and Fc Fusion Proteins
17. Reversible Self-Association of Pharmaceutical Proteins: Characterization and Case Studies

Part 3 Development of Formulation for Lyophilized Dosage Form.

18. Design of a Formulation for Freeze Drying
19. Protein Conformation and Reactivity in Amorphous Solids
20. The Impact of Buffer on Solid-State Properties and Stability of Freeze-Dried Dosage Forms
21. Stabilization of Lyophilized Pharmaceuticals by Control of Molecular Mobility: Impact of Thermal History
22. Structural Analysis of Proteins in Dried Matrices
23. The Impact of Formulation and Drying Processes on the Characteristics and Performance of Biopharmaceutical Powders

Part 4 Manufacturing Sciences

24. Manufacturing Fundamentals for Biopharmaceuticals
25. Protein Stability during Bioprocessing
26. Freezing and Thawing of Protein Solutions
27. Strategies for Bulk Storage and Shipment of Proteins
28. Drying Process Methods for Biopharmaceutical Products: An Overview
29. Spray Drying of Biopharmaceuticals and Vaccines
30. Development and Optimization of Freeze Drying Process
31. Considerations for Successful Lyophilization Process Scale-up, Technology Transfer and Routine Production
32. Process Robustness in Freeze-Drying of Biopharmaceuticals
33. Filling Processes and Technologies for Liquid Biopharmaceuticals
34. Leachables and Extractables
35. Primary Container/Closure Selection for Biopharmaceuticals
36. Pre-filled Syringes for Biopharmaceuticals
37. Impact of Manufacturing Processes on the Drug Product Stability and Quality

Index

click here to see books of related interest