CENTRE FOR DOCTORAL TRAINING IN THE EPSRC CENTRE FOR INNOVATIVE MANUFACTURING IN EMERGENT MACROMOLECULAR THERAPIES

Lead Research Organisation: University College London
Department Name: Biochemical Engineering

Abstract

The focus of the proposed EPSRC CDT will be on manufacturing research and training required in the most rapidly
developing parts of the UK bio-centred pharmaceutical and healthcare biotechnology sector, that have major implications
for future medicine. The bioprocess industry manufactures novel macromolecular drugs, proteins, to address a broad range
of chronic and debilitating human diseases. The UK holds a leading position by virtue of its science base and has unique university capabilities underpinning the sector. Whilst revenues are large, ~£110bn in 2009 on a worldwide basis, there are
huge pressures on the industry for change if demands for cost reduction and waste minimisation are to be met, and
populations are to benefit from the potent drugs becoming available. A sea change in manufacturing will be needed over
the next decade if the potential of modern drugs are to make their way through to widespread distribution. Moreover this is
a widely accepted skills shortage of individuals with the manufacturing research training needed for the sector.
Alignment to the EPSRC Centre for Innovative Manufacturing in Emergent Macromolecular Therapies will deliver increased
national capability through training of the next generation of highly skilled and talented bioprocess manufacturing
researchers. Our aim is to train bioprocess engineering leaders of the future who will underpin translation of new scientific
advances into safely produced, more selective, therapies for currently intractable conditions at affordable costs. To achieve
this we will embed CDT PhDs within the vibrant research community of the top UK Institutions and that of the EPSRC
Centre for Innovative Manufacturing in Emergent Macromolecular Therapies, to ensure that they benefit in terms of impact
and knowledge transfer from the links to research led companies. The gearing in of these collaborations will enable the
CDT to explore new and emerging ideas in a training environment that draw on research excellence and to create strong
synergy between the Centre research programmes.

Planned Impact

The proposed EPSRC Centre for Doctoral Training (CDT) aligned to the EPSRC Centre for Innovative Manufacture of
Emergent Macromolecular Therapies will be significant. The CDT will address an acute skills storage of trained manpower
needed to take this industry forward for the benefit of the UK, and ultimately improve the levels of healthcare provision. This
is a radical new opportunity for the industry which suffers from a lack of joined up thinking and hence tends to operate in
discrete silos of expertise whereas an integrated approach, as offered by the CDT, would pay high dividends.UK-based
companies will benefit from access to highly skilled doctorates who will each have benefited from a wide and
interdisciplinary approach to their research and its application created by the CDT. The CDT studies will allow UK
companies to understand better likely routes for manufacturing of their medicines and to have, for the first time, a genuine
capacity to achieve robust control in spite of biological variability. Manufacturing efficiencies will be raised and waste
reduced. The CDT will create a network to provide a conduit for effective knowledge exchange from the very best academic
groups in the UK. A key metric of success will be retention of CDT graduates within the industry where they will be effective
in the application of Centre concepts with industrial practice and the adoption of the methods created. Potential patients will
benefit because the innovations created by the CDT research will significantly aid reduction in development times of
macromolecular medicines, which is particularly crucial for those addressing previously unmet clinical needs and the
treatment of severe conditions such as arthritis and cardiovascular disease, as well as vaccines for previously
unpreventable viral infections and cancers. By providing industry the capabilities and tools to achieve changes to
manufacturing processes we shall, for the first time, open up possibilities for major improvements to processes during
production and hence reduce costs to the NHS. The capacity to treat conditions such as rheumatoid arthritis more
effectively in ageing populations is vital but it still poses a problem with respect to stretched NHS budgets. A significantly
greater number of drugs will be capable of meeting NICE's thresholds and benefit extended patient populations.The UK
economy will benefit because the academic research and training offered by the CDT will complement the country's
strength in bioscience discovery. Collaboration between bioprocess engineers, process modellers manufacturing experts,
regulators and physical scientists will ensure effective knowledge and skills transfer between the science and engineering
base and UK industry and the regulating agencies. This will expand the UK position in the global healthcare market and
attract R&D investment from global business which recognises the UK as a place to conduct these activities.
Macromolecular medicines are complex and labile so that bioprocess development times and costs tend to be high due to
unforeseen issues that occur during scale-up of the manufacturing processes. Currently there is little scope to alter a
manufacturing processes because we cannot readily predict the effects that such changes will have. This is compounded
by lack of individuals skilled in the methods needed. This transformative research training agenda will allow for the first time
engineers and scientists to create the methods and approaches needed to control directly the quality of output during
manufacture. By creating and then testing manufacturing models and methods for whole bioprocesses using the resources
of a national EPSRC Centre we shall gain fundamental engineering insights crucial for more effective direction of
acquisitions of experimental data and also the improved design and operation of whole bioprocesses. These will together
raise manufacturing efficiencies and reduce waste.

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