LyoPRONTO: an Open-Source Lyophilization Process Optimization Tool.

Area of Science:

• Pharmaceutical Sciences
• Chemical Engineering
• Biotechnology

Background:

• Lyophilization is a critical process for stabilizing pharmaceuticals and biologics.
• Optimizing lyophilization cycles is essential for reducing costs and ensuring product stability.
• Existing simulation tools can be complex and lack integrated optimization capabilities.

Purpose of the Study:

• To introduce LyoPRONTO, a user-friendly software tool for lyophilization simulation and process optimization.
• To validate the accuracy of LyoPRONTO's freezing and primary drying calculations against experimental data.
• To demonstrate the effectiveness of LyoPRONTO's optimization module in reducing primary drying times.

Main Methods:

• Development of LyoPRONTO, incorporating 0D lumped capacitance modeling for freezing and 1D heat and mass transfer analysis for primary drying.
• Implementation of a design-space generator and a primary drying optimizer that accounts for time-varying product resistance.
• Validation of simulation accuracy using experimental measurements for product temperature and drying time.

Main Results:

• The freezing calculator showed good agreement with experimental temperature variations.
• The primary drying calculator predicted drying times with an average deviation of 3% from experimental results.
• Optimized cycles using LyoPRONTO resulted in 62% faster primary drying for 5% mannitol and 50% for 5% sucrose solutions compared to typical conditions.

Conclusions:

• LyoPRONTO provides accurate simulations and effective optimization for lyophilization processes.
• The tool can significantly reduce primary drying times and operational costs.
• LyoPRONTO contributes to the development of advanced, potentially automated, freeze-dryer systems.