Software Tools For Pharmaceutical Lyophilization Process Development

By Emily Gong, Senior Research Scientist

Lyophilization is a complex process, and development of optimized processes that are economical and robust can be costly and time-consuming. Lyophilization cycles must produce quality product across and between batches, and therefore, must account for process heterogeneity. Many companies lack the tools, staff, and experience in pharmaceutical freeze-drying which can lead to inefficient drying cycles, failed batches, increased costs, and delays in drug production. Accurate and easy-to-use software modeling tools can alleviate some of these issues and speed up the scale-up process.

Here we summarize a recent a webinar describing a software modeling tool developed to optimize conditions for the primary drying cycle and while accounting for heterogeneity within and between batches of drug products.