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Details of Grant 

EPSRC Reference: EP/H028277/1
Title: EPSRC Centre for Innovative Manufacturing in Regenerative Medicine
Principal Investigator: Medcalf, Professor N
Other Investigators:
Richardson, Professor JB Liu, Dr Y Denning, Professor C
Rose, Professor FRA El Haj, Professor A Petzing, Dr J
Alexander, Professor C Hewitt, Professor C Mather, Professor ML
Somekh, Professor M Thomas, Professor R Segal, Dr JI
Johnson, Professor W Crowe, Professor J Williams, Professor D
Shakesheff, Professor K Ratchev, Professor SM
Researcher Co-Investigators:
Project Partners:
Assoc of British Healthcare bioProcessUK KTN British Standards Institution BSI
Cell Medica Critical Pharmaceuticals East Midlands Development Agency
East Midlands Strategic Health Authority EpiStem Ltd Future Health
Inst for Surface and Boundary Layers Intercytex Lonza Biologics
McGowan Inst for Regenerative Medicine MedCell Medicines & Healthcare pdts Reg Acy MHRA
Medilink Nat Inst for Bio Standards National Physical Laboratory NPL
NHS Pfizer Regentec Limited
RepRegen Sigma-Aldrich Group Smith & Nephew
TiGenix Ltd UK BioIndustry Association (BIA) University Hospitals of Leicester NHS
Wake Forest University
Department: Sch of Mechanical and Manufacturing Eng
Organisation: Loughborough University
Scheme: Standard Research
Starts: 01 September 2010 Ends: 29 February 2016 Value (£): 5,847,887
EPSRC Research Topic Classifications:
Manufact. Enterprise Ops& Mgmt Manufacturing Machine & Plant
Tissue Engineering
EPSRC Industrial Sector Classifications:
Healthcare Pharmaceuticals and Biotechnology
Related Grants:
Panel History:
Panel DatePanel NameOutcome
09 Dec 2009 IMRC Interview Panel Announced
Summary on Grant Application Form
Regenerative medicine (RM) is a convergence of conventional pharmaceutical sciences, medical devices and surgical intervention employing novel cell and biomaterial based therapies. RM products replace or regenerate damaged or defective tissues such as skin, bone, and even more complex organs, to restore or establish normal function. They can also be used to improve drug testing and disease modelling. RM is an emerging industry with a unique opportunity to contribute to the health and wealth of the UK. It is a high value science-based manufacturing industry whose products will reduce the economic and social impact of an aging population and increasing chronic disease.The clinical and product opportunities for RM have become clear and a broad portfolio of products have now entered the translational pipeline from the science bench to commercialisation and clinical application. The primary current focus for firms introducing these products is first in man studies; however, success at this stage is followed by a requirement for a rapid expansion of delivery capability - the 'one-to-many' translation process. This demands increasing attention to regulatory pathways, product reimbursement and refinement of the business model, a point emphasised by recent regulatory decisions demanding more clarity in the criteria that define product performance, and regulator initiatives to improve control of manufacturing quality. The IMRC will reduce the attrition of businesses at this critical point in product development through an industry facing portfolio of business driven research activities focussed on these translational challenges. The IMRC will consist of a platform activity and two related research themes. The platform activity will incorporate studies designed to influence public policy, regulation and the value system; to explore highly speculative and high value ideas (particularly clinically driven studies); and manufacturing-led feasibility and pilot studies using state of the art production platforms and control. The research themes will focus on areas identified as particular bottlenecks in RM product translation. The first theme will explore the delivery, manufacturing and supply processes i.e. the end to end production of an RM product. Specifically this theme will explore using novel pharmaceutical technology to control the packaged environment of a living RM product during shipping, and the design of a modular solution for manufacturing different cell based therapies to the required quality in a clinical setting. The second research theme will apply quality by design methods to characterise the quality of highly complex RM products incorporating cells and carrier materials. In particular it will consider optical methods for non-invasive process and product quality control and physicochemical methods for process monitoring.The IMRC will be proactively managed under the direction of a Board and Liaison Group consisting of leading industrialists to ensure that the Centre delivers maximum value to the requirements of the business model and assisting the growth of this emerging industry.
Key Findings
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Potential use in non-academic contexts
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Impacts
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Summary
Date Materialised
Sectors submitted by the Researcher
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Project URL: http://www.epsrc-regen-med.org/
Further Information:  
Organisation Website: http://www.lboro.ac.uk