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Details of Grant 

EPSRC Reference: EP/P006485/1
Principal Investigator: Titchener-Hooker, Professor N
Other Investigators:
Rafiq, Dr QA Szita, Professor N Wall, Professor I
Bracewell, Professor DG Dalby, Professor PA Aylott, Professor J
Brass, Dr I Branke, Professor J Thomas, Professor R
Morris, Professor S Veraitch, Dr FS Farid, Professor S
Lennox, Professor B Shah, Professor N Petersen, Professor A
Researcher Co-Investigators:
Project Partners:
Albumedix Ltd Allergan Limited (UK) Assoc of the British Pharm Ind (ABPI)
AstraZeneca Autolus Ltd BIA Separations
BioLogicB, LLC BioPharm Services Limited Cell Therapy Catapult (replace)
Centre for Process Innovation CPI (UK) deltaDOT Ltd ELI Lilly and Company
FloDesign Sonics Francis Biopharma Ltd FUJIFILM UK Ltd
GlaxoSmithKline plc (GSK) Knowledge Transfer Network Limited LGC Ltd
Lonza Biologics Medicines Manufacturing Ind Partnership Merck & Co., Inc. (Sharp & Dohme (MSD))
Merck KGaA Nat Inst for Bio Standards Novo Nordisk A/S
Oxford BioMedica (UK) Ltd Perceptive Engineering Ltd Pfizer
Puridify LTD Purolite Reneuron Ltd
Roche Sartorius Stedim UK Limited Sutro Biopharma
Tillingbourne Consulting Limited TrakCel UCB
UK BioIndustry Association (BIA) Wyatt Technology UK Ltd
Department: Biochemical Engineering
Organisation: UCL
Scheme: Standard Research
Starts: 01 January 2017 Ends: 31 December 2023 Value (£): 10,851,090
EPSRC Research Topic Classifications:
Bioprocess Engineering Macro-molecular delivery
Manufact. Enterprise Ops& Mgmt Manufacturing Machine & Plant
EPSRC Industrial Sector Classifications:
Manufacturing Healthcare
Pharmaceuticals and Biotechnology
Related Grants:
Panel History:
Panel DatePanel NameOutcome
14 Jul 2016 Manufacturing Hubs 2016 Interviews Announced
13 Jun 2016 Manufacturing Hubs 2016 Full Sift Announced
Summary on Grant Application Form
By 2025 targeted biological medicines, personalised and stratified, will transform the precision of healthcare prescription, improve patient care and quality of life. Novel manufacturing solutions have to be created if this is to happen. This is the unique challenge we shall tackle. The current "one-size-fits-all" approach to drug development is being challenged by the growing ability to target therapies to only those patients most likely to respond well (stratified medicines), and to even create therapies for each individual (personalised medicines). Over the last ten years our understanding of the nature of disease has been transformed by revolutionary advances in genetics and molecular biology.

Increasingly, treatment with drugs that are targeted to specific biomarkers, will be given only to patient populations identified as having those biomarkers, using companion diagnostic or genetic screening tests; thus enabling stratified medicine. For some indications, engineered cell and gene therapies are offering the promise of truly personalised medicine, where the therapy itself is derived at least partly from the individual patient. In the future the need will be to supply many more drug products, each targeted to relatively small patient populations. Presently there is a lack of existing technology and infrastructure to do this, and current methods will be unsustainable. These and other emerging advanced therapies will have a critical role in a new era of precision targeted-medicines. All will have to be made economically for healthcare systems under extreme financial pressure. The implications for health and UK society well-being are profound

There are already a small number of targeted therapies on the market including Herceptin for breast cancer patients with the HER2 receptor and engineered T-cell therapies for acute lymphoblastic leukaemia. A much greater number of targeted therapies will be developed in the next decade, with some addressing diseases for which there is not currently a cure. To cope, the industry will need to create smarter systems for production and supply to increasingly fragmented markets, and to learn from other sectors. Concepts will need to address specific challenges presented by complex products, of processes and facilities capable of manufacture at smaller scales, and supply chains with the agility to cope with fluctuating demands and high levels of uncertainty.

Innovative bioprocessing modes, not currently feasible for large-scale manufacturing, could potentially replace traditional manufacturing routes for stratified medicines, while simultaneously reducing process development time. Pressure to reduce development costs and time, to improve manufacturing efficiency, and to control the costs of supply, will be significant and will likely become the differentiating factor for commercialisation.

We will create the technologies, skill-sets and trained personnel needed to enable UK manufacturers to deliver the promise of advanced medical precision and patient screening. The Future Targeted Healthcare Manufacturing Hub and its research and translational spokes will network with industrial users to create and apply the necessary novel methods of process development and manufacture. Hub tools will transform supply chain economics for targeted healthcare, and novel manufacturing, formulation and control technologies for stratified and personalised medicines. The Hub will herald a shift in manufacturing practice, provide the engineering infrastructure needed for sustainable healthcare. The UK economy and Society Wellbeing will gain from enhanced international competitiveness.

Key Findings
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