BioStaRT - Biopharmaceutical Stability at Room Temperature

BioStart aim is to produce lyophilised protein formulations that are stable at room temperature and which reconstitute without compromising product quality (esp. aggregation). Stability at room temperature will extend shelf life and reduce the cold chain costs of refrigerated transportation and storage. Current methods for the development of protein formulations for subsequent lyophilization are largely empirical with little understanding of the mechanistic relationships between the characteristics of the protein and the impact of formulation (esp. electrostatic parameters which influence the protein structure and aggregation state) in relation to the physical changes that occur on freeze-thawing and freeze-drying. THE INVENTIVE STEP in the Bio-StaRT programme is the development and implementation of a number of advanced measurement technologies that integrate microscale down strategies for formulation screening (based on fluorescence, midIR and NIR microwell analysis) with new methods (LyoDEA) for the development of process understanding in order to increase the success rate for developing room temperature stable biopharmaceuticals.