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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.
This course must be taught at a BioNetwork location.
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
- Discuss the principles and theory underlying lyophilization
- Perform freeze-dryer cycle development
- Relate product formulations to freeze-drying success
- Troubleshoot freeze-dried product failures
Technicians in pharmaceutical manufacturing including:
- Lyophilization specialists
- Validation Engineers
- Process Technicians
- Production Technicians
- Quality Control/Quality Assurance personnel