BioNetwork Course: Freeze-Drying Fundamentals

Learn the principles and techniques of manufacturing lyophilized biopharmaceutical products. Biologics, vaccines, and other pharmaceutical ingredients may require freeze-drying and moisture analysis for product stabilization and long-term storage. This course gives you a theoretical foundation and practical experience in lyophilization.

Topics Include

The course is 20 hours, conducted in two 8-hour sessions and one 4-hour session on the third day and covers:

• Principles of lyophilization: primary drying, secondary drying, eutectic points, and collapse temperatures
• Lyophilization cycle set up and operation
• Thermal analysis of product formulations using Differential Scanning Calorimetry (DSC) and Freeze-Drying Microscopy
• Residual moisture content analysis of finished product
• Troubleshooting lyophilization failures

Learning Objectives

• Discuss the principles and theory underlying lyophilization
• Perform freeze-dryer cycle development
• Relate product formulations to freeze-drying success
• Troubleshoot freeze-dried product failures

Audience

Technicians in pharmaceutical manufacturing including:

• Lyophilization specialists
• Validation Engineers
• Process Technicians
• Production Technicians
• Quality Control/Quality Assurance personnel