Production of biopharmaceutical dried-powders using supercritical CO₂ technology

The inability of many biopharmaceutical formulations to retain their structure and integrity when in solution represents a major issue for their transport and storage, reducing their shelf-life and activity/stability. The ability to efficiently produce dried solid dosage forms of biopharmaceuticals such as proteins and nucleic acids allows for many improvements in the way in which these sensitive materials are stored, transported, and administered. While freeze-drying is an established drying method implemented in the biopharmaceutical industry with well-understood challenges, there has been a distinct lack of uptake in the development and usage of spray drying and supercritical fluid drying. These technologies typically provide distinct particles sizes and morphologies, introducing an additional route to improve the final product performance. This review focuses on the key aspects of various supercritical fluid methods reported in the literature to produce dried biopharmaceutical powders with enhanced stability compared to those produced by more conventional methods.