Understanding, control and design of freeze drying processes for pharmaceutical and food application

Freeze drying (lyophilisation) is an important liquid-solid separation technique that consists of freezing a solution and then removing the solvent via its sublimation. It is particularly suitable for biological samples and biopharmaceuticals (e.g. therapeutic proteins) since it conducted at low temperatures that prevent molecular product degradation. Lyophilized biomolecules are more stable than their aqueous solutions and, therefore, they can be stored for longer times. This process is also used for several food products (e.g. fruits, coffee) for their longer preservation.

Lyophilisation is a very complex processe that is currently performed mainly at small scales because of the difficulty to both monitor and scale up. The aim of this project is to obtain a deep understanding of freezing processes for lyophilization for pharmaceuticals and bio-therapeutics, by analyzing the effect of different operating conditions and formulations on the quality of the final product in terms of crystallinity, stability, purity and mechanical properties.

This project will involve the use of several analytical techniques (e.g., polarized hot stage microscopy and Raman spectroscopy, cryo-SEM and DSC, acoustic attenuation measurement, x-ray scattering and solid state NMR) for the study of nucleation and growth phenomena during freezing processes and for the determination of the crystalline structure of the final dried powders.