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.

Part 1. Formulation Development of Biologics

Introduction into Formulation Development of Biologics
Part 2. Challenges with Excipients
Polysorbate Degradation and Quality
Sucrose and Trehalose in Therapeutic Protein Formulations
Part 3. High Concentration Proteins
Introduction to High-Concentration Proteins
Solubility, Opalescence & Particulate Matter
Analytical Characterization and Predictive Tools for Highly Concentrated Protein Formulations
Practical Considerations for High Concentration Protein Formulations
Part 4. Container-Closure Systems
Parenteral Container Closure Systems
Development of Prefilled Syringe Combination Products for Biologics
Special Topics in Analytics of Pre-filled Syringes
C Mini-Pumps
Container Closure Integrity Testing of Primary Containers for Parenteral Products
Chemical Durability of Glass - Delamination
Part 5. Processing Considerations
Bulk Protein Solution: Freeze Thaw Process, Storage and Shipping Considerations
Leachables and Extractables: From Regulatory Expectations to Laboratory Assessment
Biotherapeutic Drug Product Manufacturing and Process Development
Line Sterilization Considerations and VHP
Lyophilization: Process Design, Robustness and Risk Management
Fogging
Scientific Approaches for the Application of QbD Principles in Lyophilization Process Development
Manufacturing of Highly Potent Drug Product in a Clinical Multi-Product Aseptic Facility and Transfer of Principles to Antibiotic Drug Product
Part 6. Novel Constructs
Introduction into Novel Constructs
Novel Constructs - Half-Life Extensions
Fc Fusion Proteins
Part 7. Lifecycle Management
Lifecycle Management of Biotherapeutic Dosage Forms
Switching from an IV to an SC Formulation - Considerations for Formulation Development and Formulation Bridging.