720585Concentrating on Better HealthcareClosedGRD Development of PrototypeInnovate UKXstalBio is a protein medicine formulation and delivery company that seeks to enable better and more cost effective treatments for patients. The company has developed and patented technology for converting delicate therapeutic proteins into stable dry powders via a simple, fast and standardised manufacturing process. Prior to administration the dry protein particles may be rapidly re-dissolved to very high concentration so that protein drugs can be conveniently delivered to patients in a single monthly injection and preferably at home. XstalBio now need to develop a prototype plant that can demonstrate that the dry powders can be manufactured at a commercial scale safely and reproducibly. A key barrier until now has been finding a way to test different equipment options for a critical concentration step in the process because at pilot scale these are not available in a format that can handle processing of flammable solvents. This project will firstly enable XstalBio to develop an isolator facility that can be used to exclude oxygen from where the equipment is being tested, thus allowing the process to be run safely. The next step will be to compare a range of equipment supplied by vendors for continuously concentrating protein particles at pilot scale to determine which gives the best overall performance. Finally the selected concentrator will be integrated with the other process equipment in a fully operational prototype that is designed to be scaled-up further for manufacture. Once XstalBio has demonstrated a large scale process for preparing dry protein powders can be carried out safely and cost-effectively and without altering the potency of the drug, the company intend to compete aggressively for business with more expensive protein drying options such as freeze-drying or spray drying. In the longer term the project should lower the cost of medicines for healthcare providers and increase compliance and convenience for patients.