BioStaRT - Biopharmaceutical Stability at Room Temperature
Lead Participant:
GEA PROCESS ENGINEERING LIMITED
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 |
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GEA PROCESS ENGINEERING LIMITED | £113,689 | £ 46,125 |
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Participant |
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BLUEFROG DESIGN LIMITED | ||
ONCOLYTIKA LTD | £22,212 | £ 13,328 |
BLUE FROG DESIGN | £182,709 | £ 101,700 |
DE MONTFORT UNIVERSITY HIGHER EDUCATION CORPORATION | £165,659 | £ 165,659 |
CYTOLYTIX LIMITED |
People |
ORCID iD |
John Hall (Project Manager) |