This training program will discuss each of the critical aspects of freeze drying and the related effects of variables. The course will also discuss sublimation rate variability, heat transfer, loss of protein activity, and freezing effects on primary drying.
Why Should You Attend:
The fundamental principles and technology are coupled with practical aspects of lyophilization in this training program. The principles and concepts presented will form the basis to discuss real world practical applications. The webinar will address critical aspects of freeze drying to ensure compliance, validation and minimization of patient risk based on the development of the product proven to have been during the clinical trials before the product was transferred into commercial scale operations.Areas Covered in the Webinar:
- Lyophilization 101 - Comprehension on each step of the freeze drying/lyophilization process
- Understanding why various steps of the process become more advantageous and cost effective
- Sublimation rate variability
- Heat transfer
- Loss of protein activity
- Freezing effects on primary drying
- Optimization of primary drying and proof of the effectiveness of secondary drying
- Effects of freezing method and excipients on protein surface
- Influence of packing density and the container selection
- Residual moisture regulatory considerations by the FDA
Who Will Benefit:
- Development
- Operations
- Engineering
- Technical services
- Quality
- Validation
- Regulatory affairs
Course Provider
Jerry Dalfors,
