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A new microfluidic tool for rapid analysis of protein stability and integrity in bioprocesses

ReferenceBB/E005942/1
Principal Investigator / Supervisor Professor Paul Dalby
Co-Investigators /
Co-Supervisors		 Professor Gabriel Aeppli, Professor Daniel Bracewell, Professor Quentin Pankhurst
Institution University College London
DepartmentBiochemical Engineering
Funding typeResearch
Value (£) 424,203
StatusCompleted
TypeResearch Grant
Start date 08/01/2007
End date 07/01/2010
Duration36 months

Abstract

Analysis of protein stability is currently too slow and requires too much of an exceedingly valuable biopharmaceutical to be useful in guiding bioprocess development or control. Introducing the first microfluidic method for protein stability testing will reduce sample use and cost of analysis by up to 108-fold over microwell-based analysis. Combined expertise from biochemical engineering and the London Centre for Nanotechnology will enable this analysis with parallelism for up to 1000 samples per day. The new generation of protein-based medicines has rapidly become a $30billion-a-year industry addressing previously untreatable diseases. They have the potential for much further growth but a principal constraint is the high cost of the manufacturing methods required to preserve the structural integrity of proteins with limited stability. The ability to perform rapid and parallel protein stability characterisation experiments, at the microfluidic scale, is essential to enable: a) the rapid optimisation of therapeutic protein formulations; and b) the real-time monitoring of protein product quality in process-, microwell- and microfluidic scale bioprocess development experiments. Our preliminary research has demonstrated protein stability determination using fluorescence measurements at the microwell scale (Aucamp et al., 2005). The aims of this proposal are to a) explore the fundamentals that impact on measurement accuracy and sensitivity at the microfluidic scale, so as to significantly decrease the sample volumes required for protein stability measurement; b) establish a microfluidic denaturation technique; c) overcome the challenges that will enable broad application to bioprocessing and formulation of biopharmaceutical protein products.

Summary

Analysis of protein stability is currently too slow and requires too much of an exceedingly valuable biopharmaceutical to be useful in guiding bioprocess development or control. Introducing the first microfluidic method for protein stability testing will reduce sample use and cost of analysis by up to 108-fold over microwell-based analysis. Combined expertise from biochemical engineering and the London Centre for Nanotechnology will enable this analysis with parallelism for up to 1000 samples per day. The new generation of protein-based medicines has rapidly become a $30billion-a-year industry addressing previously untreatable diseases. They have the potential for much further growth but a principal constraint is the high cost of the manufacturing methods required to preserve the structural integrity of proteins with limited stability. The ability to perform rapid and parallel protein stability characterisation experiments, at the microfluidic scale, is essential to enable: a) the rapid optimisation of therapeutic protein formulations; and b) the real-time monitoring of protein product quality in process-, microwell- and microfluidic scale bioprocess development experiments. Our preliminary research has demonstrated protein stability determination using fluorescence measurements at the microwell scale (Aucamp et al., 2005). The aims of this proposal are to a) explore the fundamentals that impact on measurement accuracy and sensitivity at the microfluidic scale, so as to significantly decrease the sample volumes required for protein stability measurement; b) establish a microfluidic denaturation technique; c) overcome the challenges that will enable broad application to bioprocessing and formulation of biopharmaceutical protein products.
Committee Closed Committee - Engineering & Biological Systems (EBS)
Research TopicsIndustrial Biotechnology, Pharmaceuticals, Technology and Methods Development
Research PriorityX – Research Priority information not available
Research Initiative Bioprocessing Research Industry Club (BRIC) [2006-2012]
Funding SchemeX – not Funded via a specific Funding Scheme
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