Principles and Practices of Lyophilization in Product Development and Manufacturing

Overview of Freeze Drying .- Characterization and Determination of Freeze Drying Properties of Frozen Formulations - Case Studies.- Beyond pH: Acid/base relationships in frozen and freeze-dried pharmaceuticals.- Concepts and Strategies in the Design of Formulation for Freeze Drying.- Formulation Design for Freeze Drying - Case studies of Stabilization of Proteins.- Challenges and Considerations in the Development of a High Protein Concentration Lyophilized Drug Product.- Freeze-drying of thermosensible pharmaceuticals with organic co-solvent + water formulations.- Primary container closure system selection for lyophilized drug products.- Vial Breakage During Lyophilization.- The Nucleation of Ice.- Stresses, Stabilization, and Recent Insights in Freezing of Biologics.- Lyophilization Process Understanding and Scale-up using ab initio Vial Heat Transfer Modeling.- Secondary drying: Challenges and Considerations.- Design and Process Considerationsin Spray Freeze Drying.- LyoPRONTO: Deterministic and Probabilistic Modeling. Tutorial and Case Study.- Utilizing Solid-State NMR Spectroscopy to Assess Properties of Lyophilized Formulations.- Design of Moisture Studies for a Lyophilized Product.- Laser-Based Headspace Moisture Analysis for Rapid Nondestructive Moisture Determination of Lyophilized Products.- Application of PAT in Real-time Monitoring and Controlling of Lyophilization Process.- Process Analytical Technology (PAT) for Lyophilization Process Monitoring and End Point Detection.- Advances in Process Analytical Technology - A Small Scale Freeze-Dryer for Process Analysis, Optimization, and Transfer.- Overview of Heat and Mass Transfer Modeling in Lyophilization to Create Design Spaces and Improve Process Analytical Tool (PAT) Capability.- Application of QbD elements in the Development and Manufacturing of a Lyophilized product.- Characterization of Freeze Dryer.- Scale-up and Technology Transfer of a Lyophilization Process.- Lyophilization Validation: Process Design and Modeling.- Lyophilization Validation: Process Qualification and Continued Process Verification.- Homogeneity Assessment of Lyohilized Biological Drug Products During Process Performance Qualification.- Informed Manufacturing through the use of Big Data Analytics for Freeze Drying Process & Equipment.- Multivariate Analysis for Process Understanding, Continuous Process Verification and Condition Monitoring of Lyophilization Processes.- Lyophilized Drug Product Cake Appearance: What Is Acceptable?.