Challenges in Protein Product Development

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.

Nicholas W. Warne is currently Senior Director of Formulations and Drug Product Process Development at Pfizer. Dr. Warne has 28 years of industrial experience focusing on biologics formulation development, dosage form design and manufacturing process development. He and his team have been fortunate to have contributed to the licensure of 10 biologics including clotting factors, growth proteins, mabs, vaccines and ADCs. Dr. Warne holds numerous protein formulation patents and, with his group, has made over 100 presentations at national meetings and in journals. Prior to his position at Pfizer, Dr. Warne had positions of increasing responsibility at Wyeth and Genetics Institute, and has been based in Andover, Massachusetts.