Challenges in Protein Product Development 1st edition by Nicholas Warne 3319906034 9783319906034

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ISBN-10 :  3319906034 

ISBN-13 :  9783319906034

Author: Nicholas W. Warne 

  In this volume, the authors discuss the many significant challenges currently faced in biotechnology dosage form development, providing guidance, shared experience and thoughtful reflection on how best to address these potential concerns. As the field of therapeutic recombinant therapeutic proteins enters its fourth decade and the market for biopharmaceuticals becomes increasingly competitive, companies are increasingly dedicating resources to develop innovative biopharmaceuticals to address unmet medical needs. Often, the pharmaceutical development scientist is encountering challenging pharmaceutical properties of a given protein or by the demands placed on the product by stability, manufacturing and preclinical or clinical expectations, as well as the evolving regulatory expectations and landscape. Further, there have been new findings that require close assessment, as for example those related to excipient quality, processing, viscosity and device compatibility and administration,solubility and opalescence and container-closure selection. The literature varies widely in its discussion of these critical elements and consensus does not exist. This topic is receiving a great deal of attention within the biotechnology industry as well as with academic researchers and regulatory agencies globally. Therefore, this book is of interest for business leaders, researchers, formulation and process development scientists, analytical scientists, QA and QC officers, regulatory staff, manufacturing leaders and regulators active in the pharmaceutical and biotech industry, and expert reviewers in regulatory agencies.

Challenges in Protein Product Development 1st Table of contents:

Part I. Formulation Development of Biologics
1. Introduction into Formulation Development of Biologics
Part II. Challenges with Excipients
2. Polysorbate Degradation and Quality
3. Sucrose and Trehalose in Therapeutic Protein Formulations
Part III. High Concentration Proteins
4. Introduction to High-Concentration Proteins
5. Solubility, Opalescence, and Particulate Matter
6. Analytical Characterization and Predictive Tools for Highly Concentrated Protein Formulations
7. Practical Considerations for High Concentration Protein Formulations
Part IV. Container-Closure Systems
8. Parenteral Container Closure Systems
9. Development of Prefilled Syringe Combination Products for Biologics
10. Special Topics in Analytics of Pre-filled Syringes
11. C Mini-pumps
12. Container Closure Integrity Testing of Primary Containers for Parenteral Products
13. Chemical Durability of Glass—Delamination
14. Fogging
Part V. Processing Considerations
15. Bulk Protein Solution: Freeze–Thaw Process, Storage and Shipping Considerations
16. Leachables and Extractables: From Regulatory Expectations to Laboratory Assessment
17. Biotherapeutic Drug Product Manufacturing and Process Development
18. Line Sterilization Considerations and VHP
19. Lyophilization: Process Design, Robustness, and Risk Management
20. Scientific Approaches for the Application of QbD Principles in Lyophilization Process Development
21. Manufacturing of Highly Potent Drug Product in a Clinical Multi-Product Aseptic Facility and Transfer of Principles to Antibiotic Drug Product
Part VI. Novel Constructs
22. Introduction into Novel Constructs
23. Novel Constructs—Half-Life Extensions
24. “Fc Fusion Proteins”
Part VII. Lifecycle Management
25. Lifecycle Management of Biotherapeutic Dosage Forms
26. Switching from an IV to an SC Formulation—Considerations for Formulation Development and

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