Details of Grant

EPSRC Reference:

EP/H028277/1

Title:

EPSRC Centre for Innovative Manufacturing in Regenerative Medicine

Principal Investigator:

Other Investigators:

Liu, Dr Y	Shakesheff, Professor K	Hewitt, Professor C
Denning, Professor C	Williams, Professor D	Alexander, Professor C
Richardson, Professor JB	Somekh, Professor M	Segal, Dr JI
Petzing, Dr J	Rose, Professor FRA	Thomas, Professor RJ
Johnson, Professor W	Crowe, Professor J	El Haj, Professor A
Ratchev, Professor SM	Mather, Professor ML

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	Medilink
MHRA Medicines & Healthcare pdts Reg Acy	Nat Inst for Bio Standards and Control	National Physical Laboratory
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 Date	Panel Name	Outcome
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

Description	This information can now be found on Gateway to Research (GtR) http://gtr.rcuk.ac.uk
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