BioStaRT - Biopharmaceutical Stability at Room Temperature

Abstract

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.

Lead Participant

Project Cost

Grant Offer

Gea Process Engineering Limited, WARRINGTON £113,689 £ 46,125
 

Participant

De Montfort University, United Kingdom £165,659 £ 165,659
Blue Frog Design £182,709 £ 101,700
National Instiute for Biological standards and controls, Potters Bar £40,764 £ 40,764
Oncolytika Ltd, Ely £22,212 £ 13,328

Publications

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