Public-private research partnership announces £5M of projects to accelerate biopharmaceutical drug development
30 September 2008
Bioprocessing research in the UK has received a £5M boost following today’s announcement of nine projects to be funded by awards from the Bioprocessing Research Industry Club (BRIC). The projects aim to improve techniques for faster and more efficient development and manufacture of biological medicines.
BRIC is a BBSRC (Biotechnology and Biological Sciences Research Council)-led partnership with EPSRC (Engineering and Physical Sciences Research Council) and the UK biopharmaceutical industry, with support from bioProcessUK, and was established in 2005 to fund the very best UK academics to carry out research to underpin the rapidly growing field of biological medicines. The aim is to both understand the bioscience underpinning bioprocessing and also to improve the tools for bioprocessing and accelerate development in this field. Funding has been awarded to university scientists to investigate three main areas:
- Alternative Processes for the Recovery and Purification of Biopharmaceutical Products
- Bioprocess Integration and Intensification for Biopharmaceutical Manufacture
- Quantification and Characterisation of Products and Impurities in Biopharmaceutical Manufacture
The nine projects announced today are the third round of grants awarded by BRIC since it was launched and take the total value of research funded by the club to over £13M. The projects funded from the first round of grants have now been running for two years and will shortly be evaluated.
Dr Celia Caulcott, BBSRC Director for Innovation and Skills, said: "These projects will help UK science contribute to the important social and economic outcomes of research in the area of biological medicines. BRIC is an open and transparent collaboration between publicly funded science and the biopharmaceutical industry and is very well placed to ensure that new and existing biopharmaceutical treatments are underpinned by excellent science.
"The projects funded under the first rounds of BRIC are now well advanced. We will be evaluating how well they have done and the difference the projects will make and this will help us to determine the future direction of all BBSRC’s public-private research clubs."
Dr John Birch, Chairman of the BRIC steering group and Chief Scientific Officer at Lonza Biologics, said: "The UK is a leader in bioprocessing and we must ensure that we stimulate innovative research in our universities that is applicable to manufacture of biopharmaceuticals. BRIC’s funding of these nine projects will ensure that our academic capabilities are translated into real benefits for patients in the long run."
Catherine Coates, EPSRC Director of the Business Innovation Directorate, said: "Bioprocessing is a crucial area that can benefit from a multidisciplinary approach, encompassing engineering and the biosciences. By working together with industry to fund this club BBSRC and EPSRC can ensure that the best proposals from both our communities are successful, and can encourage scientists to work together in multidisciplinary teams."
A full list of projects funded by the BRIC third round can be found below. Amongst the highlights are:
- Large scale standardised manufacturing of stem cells – Researchers at Lougborough University and the University of Nottingham are developing scalable and standardised manufacturing methods for human therapeutic stem cells. The work will ultimately enable production of stem cells on a commercial scale
- Producing complete therapeutic proteins using bacteria – Recent research into a protein export system in bacteria called the ‘Tat’ system will be utilised by researchers at the University of Warwick and University College London. They aim to develop an entirely novel platform that will produce complete fully folded therapeutic proteins, thus bypassing major technical problems experienced with previous bacterial synthesis systems that can only produce unfolded protein
- Better freeze drying protocols – A team at Oxford University will improve protocols to minimise damage to, and potential deactivation of, therapeutic proteins by identifying and characterising changes in structure of proteins undergoing freeze drying. This will also help to identify the best carrier materials for therapeutic proteins going into e.g. pill or powder form
Notes to editors
About the projects
The nine funded projects are as follows:
- "An amphipathic reagent to extract, stabilize and purify proteins"
Dr Tim Dafforn, University of Birmingham The production of biopharmaceuticals has a number of significant technical challenges. Two of these are how to separate the biopharmaceutical product from the feedstock in which it is produced and then how to hold it in a stable state. This project will continue the development of a reagent that has unique properties which can be harnessed to overcome these problems
- "Bioprocess Intensification by MicroCapillary Separations Systems"
Professor Nigel Slater, University of Cambridge This project will implement the use of Cambridge-invented MicroCapillary Film. The film consists of parallel capillaries of just 410 microns in diameter, arranged in a flat polymer film. The films will be assembled into MicroFlow Devices and the project aims to demonstrate the advantages of this approach over conventional chromatography techniques. The researchers will use the system for the purification of monoclonal antibodies
- "A novel characterisation and separation technique for pluripotent human embryonic and hematopoietic stem cells"
Dr Nicholas Willoughby, Heriot-Watt University; Dr Paul De Sousa, University of Edinburgh Researchers will use BRIC funding to develop a scalable technique to separate and purify human stem cells. The project will investigate the innate electrical charge on the surface of different stem cells and also their surface topography. The scientists will use this knowledge to develop new techniques to separate and process stem cells
- "Integrating upstream host cell line selection and development with improved downstream bioprocessing"
Dr Mark Smales, University of Kent; Dr Daniel Bracewell, University College London An important step in producing therapeutic proteins inside mammalian cells in culture is the removal of other proteins and products that the cell produces. This project aims to develop improved knowledge and strategies to remove these contaminate proteins in downstream processing. By developing this approach the team believes that new, more efficient and cost effective processes for purifying proteins for therapeutic use can be designed
- "Developing scalable and standardised manufacturing methods for human pluripotent stem cells"
Professor Chris Hewitt, Loughborough University; Professor Lorraine Young, University of Nottingham Pluripotent human stem cells are a major emerging platform for new therapies and as pharmaceutical tools but there are major obstacles to commercial-scale production. BRIC funding will be used by this team to investigate the properties of human stem cells that may affect the ability to process them on a commercial scale and to optimise automated procedures to enable commercial scale production. The team will be using both embryonic stem cells and newly discovered induced pluripotent stem cells
- "Raman spectroscopy as a novel analytical bioprocessing tool for PAT"
Professor Royston Goodacre, University of Manchester Large scale biopharmaceutical production requires systems for the monitoring of quality control. This project at the University of Manchester aims to develop Raman spectroscopy as a tool for high-throughput monitoring of biopharmaceutical processes. Uniquely, this will provide a method of monitoring the structural integrity of biological therapies such as antibodies actually during synthesis
- "Non-invasive biophotonics tool for phenotypic identification of pluripotent stem cells and their progeny"
Dr Ioan Notingher, University of Nottingham Pluripotent stem cells for possible therapies or pharmaceutical development work will need to be derived from the inner cell mass of very early stage embryos or with the emerging technology of inducing pluripotency using viruses. Scientists then derive the type of cell they want from the pluripotent stem cell. However, derivation techniques are less than optimal and, in addition to creating the desired cell types, generate many other cell types. This project will develop non-invasive techniques to identify and separate the desired cell types, helping to remove bottlenecks that are slowing the progress of stem cells into the clinic
- "Lyophilization of proteins – an in-situ study on structural changes and molecular interactions"
Professor Zhanfeng Cui, University of Oxford Many approaches to using therapeutic proteins employ freeze drying or “lyophilisation” to increase their shelf life however this process can damage the protein and deactivate it. Using real-time functional and three dimensional imaging the group will study the molecular structures of the proteins and their interactions with carrier materials during the freeze drying process to develop better freeze drying protocols and guidance on formulations (including selection of the best carrier materials) for new and existing biopharmaceuticals
- "Exploitation of the Tat export machinery for protein production by bacteria"
Professor Colin Robinson, University of Warwick; Dr Eli Keshavarz-Moore Many recombinant proteins are currently produced in bacteria, and it is often desirable to export the product out of the bacteria. This project plans to exploit a recently discovered pathway out of the bacteria – Tat. The Tat pathway holds major advantages over current techniques because it can export fully folded proteins. The advantage of this is higher integrity of synthesised protein as compared with previously used systems that export the protein unfolded. The team plans to explore its characteristics with the aim of developing bacterial strains and export strategies with industrial potential
The Bioprocessing Research Industry Club (BRIC) was established in 2005 by BBSRC and EPSRC to focus on the delivery of investment into academic research in bioprocessing. Alongside BBSRC and EPSRC in BRIC are 18 industrial organisations: Antisoma, Avacta Ltd, Avecia Biologics, Centre of Excellence for Life Sciences, Cobra Biomanufacturing, Eden Biopharm, Glycoform, GlaxoSmithKline, HPA, Ipsen Limited, Lonza Biologics plc, MedCell Bioscience Ltd, MedImmune, NIBSC, Novozymes Delta Ltd, Pall Life Sciences, Stem Cell Sciences UK Ltd, and UCB Celltech. These organisations contribute to a joint research council-industry fund to support research projects. BRIC is managed by BBSRC, EPSRC and bioProcessUK.
The Biotechnology and Biological Sciences Research Council (BBSRC) is the UK funding agency for research in the life sciences. Sponsored by Government, BBSRC annually invests around £420M in a wide range of research that makes a significant contribution to the quality of life for UK citizens and supports a number of important industrial stakeholders including the agriculture, food, chemical, healthcare and pharmaceutical sectors. http://www.bbsrc.ac.uk
The Engineering and Physical Sciences Research Council (EPSRC) is the UK’s main agency for funding research in engineering and the physical sciences. The EPSRC invests around £800 million a year in research and postgraduate training, to help the nation handle the next generation of technological change. The areas covered range from information technology to structural engineering, and mathematics to materials science. This research forms the basis for future economic development in the UK and improvements for everyone’s health, lifestyle and culture. EPSRC also actively promotes public awareness of science and engineering. EPSRC works alongside other Research Councils with responsibility for other areas of research. The Research Councils work collectively on issues of common concern via Research Councils UK. Website address for more information on EPSRC: http://www.epsrc.ac.uk
bioProcessUK is the Technology Strategy Board-funded Knowledge Transfer Network dedicated to supporting the growth of the biological medicines development and processing sector in the UK. bioProcessUK is managed as a stand-alone business unit of the BioIndustry Association (BIA). bioProcessUK plays an important role in ensuring BRIC meets industry’s research and skill needs. http://www.bioprocessuk.org
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