Optimising Pharmaceutical Processes: A Guide To Lyophilisation Cycle Development

By Matt Bourassa, Manager, Process Development, PCI

Lyophilisation, or freeze-drying, is an essential technique in the pharmaceutical industry for preserving and stabilising drug products, particularly those sensitive to heat. This process involves freezing the product and then sublimating the solvent, resulting in a stable, solid matrix. Lyophilisation is crucial for extending the shelf life of biologics and small molecule drugs, enhancing their thermal stability, and simplifying storage and distribution logistics. As biopharmaceutical companies continue to develop innovative treatments, the demand for robust lyophilisation processes grows.

This application note provides a comprehensive guide to lyophilisation cycle development, detailing the critical steps and factors essential for successful product stabilisation.