Stabilisation of therapeutic proteins by supercritical fluid drying technologies II
01 / 2007 - unknown
In modern pharmacy and therapy, proteins have become an important category of drugs. Considering that proteins are complex molecules in sense of their size and structure, one of the biggest challenges in the development of modern pharmaceutical therapies is the formulation and stabilisation of the labile proteins. To preserve adequate chemical and physical stability during storage, many proteins are formulated as dry powder. For this purpose, traditional drying techniques such as lyophilisation and spray-drying have been applied. However, they are only moderately suitable for proteins as they cause harmful stresses such as ice crystal formation, high temperature and interfaces. Alternative supercritical fluid drying techniques are therefore explored to overcome these issues. This multidisciplinary research is performed in a joint project of Utrecht University (protein formulation expertise) and Delft University of Technology (process engineering expertise). This project is a good opportunity for students to learn more about protein formulation challenges and also about basic principles of industrial pharmacy and process engineering. Supercritical drying of proteins process design Only few supercritical drying techniques are applicable to prepare dry protein formulations. Up to now, a limited amount of research was achieved on aqueous solutions and only few people investigated the characteristics of the protein formulations upon drying and re-dissolution. The aim of this project is to develop a supercritical fluid drying process for appropriate formulations to preserve the native structure and function of therapeutic proteins dried from aqueous solutions.