Innovate UK Project Biostart launches on August 1, 2014

Innovate UK Project Biostart launches on August 1, 2014 (Project Reference 101711)

The aim of this collaborative R&D programme is to produce lyophilised protein formulations which are stable at room temperature and which reconstitute without compromising product quality (esp. aggregation). The project was instigated in response to the UK government’s Innovate UK funding competition called “Formulated Products (CRD).Meeting the Product and Process Design Challenge”.

Enhanced 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 is the development and implementation of a number of advanced measurement technologies that integrate microscale down strategies for formulation screening with new methods for process understanding, in order to increase the success rate for developing room temperature stable biopharmaceuticals. Our partners are GEA, NIBSC, Sanofi, Blue Frog Design and OncoLytika.