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O’Sullivan et al – Production of biopharmaceutical dried-powders using supercritical CO2 technology, The Journal of Supercritical Fluids, 2022, 187, 2022, 105645.

Aaron O’Sullivan, Kevin M. Ryan and Luis Padrela*

SSPC Research Centre, Department of Chemical Sciences, Bernal Institute, University of Limerick, Limerick, Ireland
Corresponding Author: Luis Padrela (luis.padrela@ul.ie)

Received 14 February 2022; Received in revised form 28 April 2022; Accepted 22 May 2022
Available online 25 May 2022

Link: https://www.sciencedirect.com/science/article/pii/S0896844622001309?via%3Dihub

• 168 relevant publications, including more than 50 publications over the past 10 years are reviewed here.
• Biomolecules produced by various drying methods are compared on the basis of stability, morphology, and particle size.
• Supercritical CO2 offers a unique alternative to conventional methods by means of water removal and high activity retention.

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.

Production of biopharmaceutical dried-powders using supercritical
CO2 technology