Lyophilization Cycle Design – A Practical Guide to Process Optimization

Lyophilization is a difficult and expensive process.  However, simple steps can be taken to minimize risks and costs.  This course will cover the process and benefits of using an empirical approach to design an optimized lyophilization cycle, which will improve the quality and consistency of the product while also reducing the cycle time and associated costs.

Topics of discussion will include:

• Thermal characterization including DSC and FDM
• Understanding the effects of working with crystalline vs. amorphous components
• The problem with working with a metastable glassy system and the use of annealing to correct this problem
• Determining optimal shelf temperatures for the freezing step
• Determining optimal shelf temperatures and chamber pressures for the primary drying step
• Determining optimal shelf temperatures and chamber pressures for the secondary drying step
• Characterization of the finished lyophilized product