EPSRC Centre for Innovative Manufacturing in Regenerative Medicine

Lead Research Organisation: Loughborough University
Department Name: Sch of Mechanical and Manufacturing Eng

Abstract

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.

Planned Impact

The impact of the research will be in three key areas: improved public health, improved business and national economic performance, and better informed public policy. Public health will be improved through the IMRC's facilitation of new therapies for unmet clinical needs. The focus of RM on chronic diseases and aging related conditions mean that these innovations will affect the population with highest levels of morbidity and therefore have maximum impact on population health. The research will have many levels of economic impact through supporting the growth of a high value industry. Key industrial collaborations will assist UK located large companies and SME's in understanding of the commercial value of their therapies and other enabling technology products, product development, and in developing cost effective manufacturing approaches. Realisation of more products in a shorter timescale will directly support both national and global economic growth but also ultimately contribute to improved public finances through reducing the escalating long term costs associated with aging and chronic disease. The establishment of a UK based centre of enabling technology in RM translation will assist in attracting inward investment to the UK from product developers who are suffering from a global skill deficit. It will create skilled employment opportunities and boost product, technology and knowledge based exports. Policy forming and regulatory bodies will benefit from our industrially informed influencing studies and focus groups. Public policy will be influenced by the preparation and dissemination of evidence documents to key stakeholders and by active participation by IMRC partners in key national and international fora and networks. The NHS are well represented in the IMRC and this involvement will be critical in any UK led clinical adoption of advanced RM therapies. The IMRC approach directly complements the public regulators' mission to drive quality and safety into product development. The clear economic, health and policy impacts will only be realised if the IMRC transforms the product development and manufacturing status of the RM industry. We are in a unique position to achieve this through the internationally competitive lead established by the remedi Grand Challenge and our extensive commercial sector engagement with a track record of focussing academic teams on solving real problems presented through our industrial collaborators. This momentum will ensure early impact from the IMRC. The Liaison Group and Board will ensure continued impact by representing the voice of industrial stakeholders and guiding the research, as well as providing a direct route back to industrial application. The timing of the impact will be three phased. The technological impact to improve product development and manufacturing process will be rapid as the IMRC builds on the momentum and work established with partners under the remedi Grand Challenge. The economic benefit will build over the first few years as technological and methodological development enable industrial partners to meet milestones, reduce risk and therefore attract investment. Health benefits and the additional associated economic benefits of lower morbidity have longer term impact due to regulatory approval and clinical adoption times. We anticipate the IMRC's activities will have visible impact in this area within a decade through traceable contributions to key product successes in this emerging industry.

Organisations

Publications

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Farrugia M (2014) Ultrasonic monitoring of drug loaded Pluronic F127 micellular hydrogel phase behaviour. in Materials science & engineering. C, Materials for biological applications

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Foster NC (2015) Dynamic 3D culture: models of chondrogenesis and endochondral ossification. in Birth defects research. Part C, Embryo today : reviews

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Gerges I (2016) A Tailor-Made Synthetic Polymer for Cell Encapsulation: Design Rationale, Synthesis, Chemical-Physics and Biological Characterizations. in Macromolecular bioscience

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Ghita A (2012) Cytoplasmic RNA in undifferentiated neural stem cells: a potential label-free Raman spectral marker for assessing the undifferentiated status. in Analytical chemistry

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Ginai M (2013) The use of bioreactors as in vitro models in pharmaceutical research. in Drug discovery today

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Ginty PJ (2011) Regenerative medicine, resource and regulation: lessons learned from the remedi project. in Regenerative medicine

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Gleadall A (2018) VOLCO: A predictive model for 3D printed microarchitecture in Additive Manufacturing

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Glen KE (2013) Production of erythrocytes from directly isolated or Delta1 Notch ligand expanded CD34+ hematopoietic progenitor cells: process characterization, monitoring and implications for manufacture. in Cytotherapy

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Gomes NM (2011) Comparative biology of mammalian telomeres: hypotheses on ancestral states and the roles of telomeres in longevity determination. in Aging cell

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Gould TW (2013) Development of a porous poly(DL-lactic acid-co-glycolic acid)-based scaffold for mastoid air-cell regeneration. in The Laryngoscope

 
Description The EPSRC Centre for Innovative Manufacturing in Regenerative Medicine is one of the primary national interventions supporting the growth of the UK regenerative medicine industry. Its role is to define, deliver and disseminate world-leading, high impact, fundamental and translational manufacturing research building upon its original funding from the EPSRC. Significant additional funding (approximately nine times the original grant received) has been secured from diverse sources. EPSRC Centre members participate significantly in hubs and projects funded by the UK Regenerative Medicine Platform. The recent re-funding of our Centre for Doctoral Training by both EPSRC and the MRC sustains our training pipeline for over 100 PhD students.
Exploitation Route The EPSRC Centre for Innovative Manufacturing (CIM) in Regenerative Medicine has come to a conclusion at the end of February 2016. The portfolio of projects that are managed by the participants at Keele, Nottingham and Loughborough continues to evolve and to enlarge. The engagement with the regulatory authorities and with the international community has increased during 2015 with initiative undertaken with the European Medicines Agency and the international Standards Organisation that will outlive the CIM. Opportunities have been identified to work in new collaborations in the USA (via MIT), France (through I-STEM), Italy (with IBSL) and Japan (through Sasakawa Foundation initiatives). Two unsuccessful bids have been made for Future Manufacturing hubs and the content of these will be re-developed for focused research projects with the industrial and academic partners concerned. As noted last year engagement goes from strength to strength through the development of new consortia-led projects, the promotion of the UK academic community in Europe and the communication of regenerative medicine science and engineering to school-age learners and their teachers. The wider EPSRC Centre has a focus on people development through EPSRC-funded Early Career, Career Acceleration and Manufacturing Fellowships. Support for early career researchers is provided through fellowships from a variety of funders, including the EPSRC-funded Engineering, Tissue Engineering and Regenerative Medicine (ETERM) Fellowship Programme and host university programmes. The research funded by the EPSRC Centre during the second half of its term was focused on the cross-institution challenge project where key manufacturing technology themes are integrated using a framework based on regulatory science to facilitate translation. We are now working actively with the Cell Therapy Catapult on industry projects and partnering strategically on research and translational projects. The work here has led to new initiatives in the area of distributed manufacturing. The relationship with the Cell and Gene Therapy Manufacturing Centre has been strengthened. Work on policy and standards and to inform regulation continues with contributions to the work of the Department of Health Regenerative Medicine Expert Group and international standards groups. Regenerative medicine manufacturing remains a key focus nationally and internationally. We are planning for success against this opportunity-rich background. We seek the ongoing support of community members, as both advocates for the importance of EPSRC funding for manufacturing research and in particular as collaborators in research that enables the new industry of regenerative medicine to grow and deliver increasing healthcare benefits. To this end the CIM has worked on policy influence as well as research output and the findings underscore the importance of a systems-level approach to manufacturing research for these advanced products. Without a thorough understanding of how to make regenerative medicines safely, economically and in sufficient quantity, these therapies will never reach their full potential.
Sectors Healthcare,Manufacturing, including Industrial Biotechology,Pharmaceuticals and Medical Biotechnology,Other
URL http://www.epsrc-regen-med.org/
 
Description Centre's impact on Industry: Quotes from Collaborators giving examples of the Centre's impact on Industry. The Centre has made significant impact within the Regenerative Medicine Industrial community as evidenced by the following quotes: From Dr Amr Abid, Head of Strategic Growth & Development, Life Sciences, GE Healthcare: "GE Healthcare Life Sciences had the opportunity to experience first-hand the uniqueness of the EPSRC Centre for Innovative Manufacturing in Regenerative Medicine at Loughborough University by working on industrial process development for our human cardiomyocytes differentiation from human stem cells. The Centre has combined in one team different capabilities, skills and talent in engineering and biology coming from industry and academia. This unique and rare blend of people, expertise and capabilities has been, and is still, extremely valuable for the project we have been working on." From David Newble, CEO, TAP Biosystems: "I am writing to endorse the collaborative support we have received from the EPSRC Centre for Innovative Manufacturing in Regenerative Medicine. In particular they have highlighted regulatory changes required to remove barriers to establishing cell therapy processing capabilities in hospital environments - a major hurdle for the adoption of certain cell therapies." From Guy Parkes, Head of Special Projects, Anthony Nolan: "The automated process that we use to extract stem cells from an umbilical cord blood collection is one of the major limiting factors in our processing chain. Our work with the team at Loughborough analysing our existing protocols and experimenting with new solutions has allowed us to both understand the limitations of our current processing system with regard to cellular yields and to identify a new method to substantially improve those yields." Hermann Hauser, 'Review of the Catapult Network: Recommendations on the future shape, scope and ambition of the programme' November 2014: "The CTC is able to work with Loughborough's recognised experts in the manufacture and quality control of cells and tissues used in cell therapy, as well as linking with the University's Engineering and Physical Sciences Research Council (EPSRC) Centre for Innovative Manufacturing and its Doctoral Training Centre in Regenerative Medicine." 1. Introduction (The items listed here that are cited under the individual output sections of ResearchFish are included in order to provide a continuous narrative only. The references given in square brackets may be found in the 'Publications' section.) As one of sixteen EPSRC Centres for Innovative Manufacturing, the EPSRC Centre for Innovative Manufacturing (CIM) in Regenerative Medicine was created in 2010 and was led from Loughborough University in the UK, in partnership with complementary groups at Keele University and The University of Nottingham. Each university brought its own expertise to create a unique partnership combining leadership in regulated manufacturing, tissue engineering and clinical science. As a National Centre, the EPSRC Centre has had an engagement programme that brought together the UK regenerative medicine manufacturing community to create a distributed centre of excellence. The EPSRC Centre was closely aligned with the EPSRC-MRC Centre for Doctoral Training in Regenerative Medicine and the E-TERM Landscape Fellowships Programme providing an integrated platform of fundamental and translational research. The EPSRC Centre for Innovative Manufacturing in Regenerative Medicine has worked to equip the industry with manufacturing tools, technologies and platforms by considering the supply chain from end to end. We have utilised a systems approach to draw together the many processes involved in transferring the right therapies to the right patient at the right time. The CIM builds on synergies between the three main universities. Keele University has provided an especially close connection with clinical application though its work with the RJAH Orthopaedic Hospital at Oswestry. The practical, logistical and clinical insight that this collaboration brings has made it possible to ensure that the CIM innovation and regulatory insights are grounded in the practical realities of the hospital setting. Nottingham has a strong materials background. The work by the group under Prof Kevin Shakesheff in thermoreversible scaffold polymers to allow integration of cell manufacture and administration reflects this. During the last three years the especial emphasis of the Nottingham work has been on integrating cell and polymer bioprinting as described below. The role of Loughborough has been twofold. On the one hand Loughborough has brought the application of automated solutions to cell processing into applications-based research. On the other hand Loughborough has focused on the regulatory context of the manufacturing research, leading to a succession of papers on the business, regulatory and quality assurance challenges and how these might be addressed. The CIM was originally structured with three major research themes: manufacturing and automation, characterisation and control, and delivery and 3D constructs. These reflected the capability of the Centre partners and the key requirements of industry. The CIM went through its international mid-stage review in April 2013. The review panel for this was chaired by Michael May, President and CEO of the Centre for Commercialization of Regenerative Medicine (CCRM), Toronto, and included international and national academic and industrial members in addition to EPSRC and TSB observers. The mid-stage review had a positive outcome with recognition of the role and potential of the Centre nationally and internationally. In summary, the review identified the Centre as "..one of a few that understands and addresses cell manufacturing bottlenecks - a critical gap in regenerative medicine commercialization". Underpinning this, the review identified the following strengths: • Partnership between three institutions, each bringing unique capabilities: Loughborough, with its industry perspective and focus on process, scale and quality systems; Nottingham, with its academic research focus and depth; and Keele with its clinical capabilities. • A strong culture of training and programmes in place to deliver highly qualified personnel with unique skill sets. • Visionary leadership tied to an extensive network of academic and industry contacts. • Excellent governance and good record keeping, with external Board representation. • Industry input to provide market pull, balancing the technology push of academia; projects that address "real-life" problems in the field. • Records indicating a rigorous, stage-gated project approval/review process. • Initial funding for an ambitious national outreach plan to connect key institutions advancing Regenerative Medicine and Cell Therapy across the UK." The review identified several major achievements attributed to the strengths of the Centre: • The CIM had widened its scope and mandate and maintained strong collaboration among the three institutions. • The CIM had identified and funded a substantial pipeline of projects in a relatively short period of time. • The CIM had attracted industry to support projects and commit time to advisory roles and Board positions. • This had brought scientists with different backgrounds and perspectives together, creating "common language and understanding", which is critical to success in such a multidisciplinary, emerging field. • Management had leveraged the Centre to create new opportunities and attract new funding to a core network of investigators. • The CIM had created links with other key players in the UK regenerative medicine research system (e.g., the Cell and Gene Therapy Catapult). Recognising the dynamic nature of the UK landscape/innovation system for regenerative medicine and its impact on the Centre, the review panel did, however, advise that to maximize its impact and track towards sustainability, the Centre needed to clarify and reinforce its vision, address succession of its leadership and make key strategic changes to its project portfolio. An action plan in response to these recommendations was successfully delivered within six months (October 2013). As a consequence, the EPSRC Centre's vision and strategic objectives (including outreach strategy) were updated, taking account of changes to the UK funding environment, in particular the Cell and Gene Therapy Catapult (CGTC, then the CTC) and the Joint Research Councils UK Regenerative Medicine Platform (UKRMP). Prof Nick Medcalf became Director of the EPSRC Centre for Innovative Manufacturing in Regenerative Medicine on 1st September 2014, succeeding the founding Director, Prof David Williams OBE. A flagship cross-institution disruptive challenge project started in November 2013. This signalled the next phase of the EPSRC Centre's research, which, by integrating key manufacturing technology themes (personalised 3D bioprinting, product characterisation and closed-loop process control) using a framework based on regulatory science, has successfully addressed significant translational bottlenecks in the industry. 1.1. The original themes The original three themes during the first review period of the CIM were compiled under the directorship of Prof David J Williams. These themes interacted in terms of their emphasis on control of processes and the role of automated equipment. Work in manufacturing and automation built upon the achievements of the remedi Grand Challenge but with a strong focus on near-patient cell processing. The projects examined the creation of novel modular process equipment for use in hospitals (with TAP Biosystems and Dana Farber Cancer Institute, Harvard), media-conditioning equipment (with Ruskinn), novel platforms for adherent culture to reduce the cost of goods (resulting in two patents), and culture in hydrostatic conditions (with Tissue Growth Technologies [Henstock 2013]). A strongly emerging theme was the management of biological variation by process design to reduce its effect. This was demonstrated in a clinical setting with the Anthony Nolan Trust [Win Niang 2015], and for human embryonic stem cell culture [Ratcliffe 2013] and cryopreservation [Mitchell 2014]. Work on near-patient processing identified the significant regulatory issues with transferring manufacture to multiple sites and the interaction between manufacturing strategy and regulation. An influential consensus white paper developed with industry shared these issues [Hourd 2014] and led to work in the key areas of quantification of biological variation (with Dana Farber and from the literature [Thurman-Newell 2015]) and the development of techniques and methods of demonstrating process comparability [Archibald 2015]. As part of PhD Candidate Jamie Thurman-Newell's project, a collaboration was struck between the Boston hospital and LU, to investigate the extent of biological variation within clinic and explore potential cell processing issues. This resulted in two on-site visits and the collaborators are now writing a joint paper. This theme has been continued as a main focus of the Loughborough involvement in the UKRMP Pluripotent Stem Cell Platform. Later work has begun to explore the manufacturing problems at the boundary of regenerative medicine and synthetic biology. A second aspect of the automation theme was research focussed on the use of statistical models within a Quality-by-Design framework to improve cell processing. The challenges that were addressed included selecting assays that had sufficient throughput and were informative enough to develop meaningful models of cell function. In particular the Centre published exemplars of the use of focussed (via appropriate risk assessment) and linked statistical models to greatly improve reproducibility and quality of high risk process operations such as cryopreservation [Ratcliffe 2013 and Mitchell 2014]. Delivery and 3D constructs was a third area of research and this was developed into a leading activity following the mid-term review. The detail is described below. 1.2. Research themes following the mid-term review After the mid-term review there were a further three themes, linked by an emphasis on the regulatory challenge that must be addressed before technology can be deployed. 'Regulatory science' was an integrating project, overarching the other three: ".. the science that will inform and enable robust regulatory decisions by both influencing and informing the regulator and assisting the manufacturer in providing the knowledge base to deliver confidence in these products". EPSRC Centre Manufacturing Industrial Summit, 2012 As part of its systems approach to the manufacture and translation of Regenerative Medicine, the Centre has built in a strong and strategic regulatory science component across the project portfolio. In the description given here the regulatory-related activity of the CIM is recounted for the whole life of the Centre and not merely the activity following the mid-term review. However, the emphasis on this aspect grew in the second half of the term. In addressing important issues identified in these and other parallel research activities, such as the TSB-funded VALUE project, and by industry stakeholders at the 'EPSRC Centre Manufacturing Industrial Summit' in 2012, new concepts addressing the major challenges for the manufacture and commercialisation of autologous and 3D tissue engineered therapies were developed. Captured in a two key positioning papers this work has contributed directly to the Centre's increased engagement with the UK regulator (MHRA), the European Regulator (EMA) and other stakeholders, including the Harvard Stem Cell Institute and the International Society for Cellular Therapy (notably via input to consultations on EU and US regulatory guidance by its Commercialisation Committee) and has directly influenced national policy with input into the Regenerative Medicine Expert Group (RMEG) (one of the key consequences of the House of Lords Report). "building stronger links between the regulators and those who are regulated would be a vital step in overcoming the difficulties of GMP requirements". House of Lords Science and Technology Committee report on Regenerative Medicine, July 2013 This work continues to influence manufacturing themes in healthcare via input into feasibility studies currently being undertaken by the EPSRC Re-Distributed Manufacturing in Healthcare Network (RiHN), in particular the 3-D Bioprinting and Cell Microfactories feasibility studies. In parallel with other research activities, for example under the UKRMP Pluripotent Stem Cell Platform (PSCP), the Centre has also driven or been involved in a number of national and international industrial and academic workshops in the regulatory science space (upstream of the CGTC). The most significant of these were the Centre-led Industry translation session at International Society for Cellular Therapy regional meeting (Philadelphia, Sept 2013), the 'Safety & Starting Materials' workshop (Sheffield, 8-9th Jan 2015, and the Comparability & Characterisation' workshop (Cambridge, 14-15th Sept 2015). Providing valuable insight into issues faced by regenerative medicine businesses, another key role of the Centre has been to provide regulatory support to regenerative medicine SMEs via the creation of a specialised role funded by the EPSRC Knowledge Transfer Account at Loughborough. Examples of companies that have benefited from this work include Organogenesis, TAP Biosystems, Cell Medica, Videregen and Intercytex, with the products ranging from stem cell treatments to wound-healing matrices. Through this role and via membership of standards committee at the British Standards Institute, the Centre has made significant contributions to three regulatory guidance documents relating to the development of cellular medicines (PAS93:2011, PAS83:2012, PAS157:2015). This work has enhanced the regulatory knowledge of the Centre, provided input into teaching materials for the Doctoral Training Centre programme and input into the development and validation of the Cell Therapy Manufacturing Facility of the Loughborough Centre for Biological Engineering. Throughout its lifetime, the Centre has indirectly influenced [Hourd 2014 and Hourd 2015] regional, national and EU policy, with invited evidentiary input into programmes such as the GO-Science Foresight 'Future of Manufacturing' project, which was presented directly to Vince Cable (Secretary of State for Business, Innovation and Skills) and the Ministerial Industry Strategy Group future strategy for medicines manufacture in the UK. This has been complemented by sustained input into several targeted stakeholder consultation programmes, including consultation on Department of Health's Advisory Committee on the Safety of Blood, Tissues, and Organs (SaBTO) cell therapies guidance; on diagnostics for Stratified Medicine (Catapult); on the Foundation for the Accreditation of Cellular Therapy (FACT) Common Standards guidance and consultation with BSI on the application of Quality by Design (QbD) to cell therapy development and standards for evaluation of materials. In November 2015 the Centre contributed to the development of Good Manufacturing Practice for Advanced Therapy Medicinal Products (European Commission). Under the Regulatory Science Work Package were three technical work packages. The first of these was the Closed-loop control activity. The purpose of the project, closely linked to the following 'Sensors' project, has been to examine the impact that management of cell culture using responsive feeding could have on the otherwise open-loop menu-driven culture that is usual for manual T-flask systems. There were two main areas of work in this section of the program. The first involved the modification of bioreactor vessels in order to achieve bleed-feed loops for nutrition management and resulted in manual in-house modification of the disposable vessels in the AMBR bioreactor system to enable progressive medium replacement and adjustment. (The AMBR is a workhorse piece of equipment in the CBE, manufactured by TAP Biosystems.) The second focussed on a worked example of real-time management of medium composition to drive the growth of chondroprogenitor cells. Preliminary studies using bovine cells from primary tissue were conducted. Further work is being continued under the EPSRC Fellowship held by N Medcalf (EP/K037099/1) The published regulatory guidance from the US and the EU highlights the importance of on-line and at-line bioprocess monitoring and control. Currently there exist fundamental engineering science challenges that limit the state-of-the-art process analytical technologies to address this need. Specificity of signal and avoidance of fouling of sensors are amongst the biggest of these challenges. To address these challenges, in the 'Sensors' project we explored a novel nonlinear acoustic detection technology for rapid receptor-based detection of biological cells and proteins. This was implemented on a 14.3 MHz quartz crystal resonator, which was driven at relatively high oscillation amplitude and acceleration (~million g). The resulting inertial loading on the attached bioparticles was observed to dissociate non-specific binding from the sensor surface, reducing fouling. The use of aptamers as bioreceptors further improved the specificity of detection. The entirely electronic detection technology implemented on a microfluidic cartridge is modular and favours easy integration with the cell reactor for online biological monitoring. The current research, extending beyond the life of the CIM, is focusing on studying the heat transfer and fluid mechanical problems for thermal stability, and fast and efficacious capture of bioparticles. This project has recently received funding from BioProNET, a BBSRC supported network, to work with the Centre for Process Innovation (CPI), a Catapult Centre, to feasibility test the technology with industry-relevant biomolecules and conditions. The Bioprinting/customised products work package (Joel Segal) has focussed on potential future clinical translation of the bioprinting process for personalised/customised combination products. Throughout the project, there has been substantial and regular clinical review (surgeon and prostheticist) which has provided essential inputs about establishing product specifications, defining critical parameters and the testing and verification required. This meant that the design of the product has been optimised for clinical need. A strongly emerging theme was the lack of a current regulatory framework for these product scenarios. This has led directly to a feasibility study project supported by the Redistributed Manufacturing in Healthcare Network (EPSRC - EP/M017559/1) Key achievements are:- • Development of a process to 3D-print tissue engineering nose constructs based on medical scans. • Creation of a bespoke insulated enclosure to control the bioprinting environment (air temperature and cooling air flow rate). • Development of an effective printing process for polycaprolactone and hydrogel (temperature settings, print extrusion rate, etc.). • Study and understanding of the effect of hydrogel formulation on printing fidelity and cell viability. • An optimal scaffold design was agreed with the surgeon and created using 3D modelling software - The scaffold needed to be as thin as possible but porous enough to enable a suturing needle to pass through without excessive force. Slots were included to house cartilage plates. • Produced software to allow finer control of the 3D print path and printing parameters for test samples than off-the-shelf software: The program enabled a novel print path concept to be utilised for control of surface porosity. The effect of surface porosity was quantified for compressive modulus, suturing forces, cell seeding and cell proliferation [Ruiz-Cantu 2016]. Software was developed to generate printer control code for a full 3D nose model. It enables fine control over the porosity: • Several different print configurations were utilised and two polymer types to achieve a range of scaffolds. Feedback from the surgeon suggested the scaffolds were ideal for this application. The work has also been presented at several conferences including Biofabrication 2015, TCES 2015 and TERMIS 2015. 2. Impact channels (International impacts, both academic and industrial, are included in section 3.) The presentation of CIM output and capability has been made principally through the Industry Days. Usually annual, the most recent of these, a two-day event at Cambridge University (Madingley Hall) in January 2016 enabled researchers to showcase their work and to co-produce a series of research priorities with the delegates via workshops on day two. The output of the meeting has been briefed informally to the EPSRC and will form the basis of a White Paper after the current reporting round. The CIM has directly and indirectly benefited industry (manufacturers and equipment providers), academia, trade organisations and regulatory and standards bodies as noted above. The industrial influence has been upon translation and practice. The Cell and Gene Therapy Catapult was established during the middle period of the EPSRC Centre funding period. There was a natural alignment between the Centre and the Catapult with the former able to supply emerging technologies, equipment and specialist services to the latter. The Centre signed a memorandum of understanding with the CGTC early in its operation, and subsequently a framework agreement to facilitate rapid deployment of packages of work. This collaborative relationship continues as part of the Centre's sustainability and forms a pipeline through which the Centre ensures that its research is positioned slightly upstream of the CGTC, providing tools, techniques and insights to operation (e.g. the work on distributed manufacture, which aligns with the CGTC theme of 'seamless freight'). The significant amount of industry work, especially by Rob Thomas' group, is partly a result of this close working relationship. The previous CEO of TAP Biosystems (now Sartorius), David Newble, commissioned a study with the CIM to evaluate the impact of the lack of a centrifugation step in the TAP cell therapy automated cell culture platform, CompacT SelecT®. This study (valued by TAP at £103k) was incorporated in the EPSRC Centre project EP051 in June 2013. Results of the testing with various cell types have been reported by the EPSRC Centre and by TAP in their marketing brochures [Archibald 2015, Archibald 2016, French 2015]. Since the first purchase of the CompacT SelecT® platform by the Centre for Biological Engineering there have been many publications on the benefits of automation of cell culture and has resulted in increased sales of the machine around the world, helping to establish it as a platform technology. The EPSRC Centre also contributed to an international effort for enabling consistency in stem cell derived products leading to the experimental design of the project. As part of PhD candidate Jamie Thurman-Newell's project, collaboration was initiated between the pharmaceutical giant GSK and LU. The aim of this collaboration was to examine how to address the processing and variation issues within cell therapy. This continued over a three year period and resulted in useful feedback that informed both industrial and academic direction. This concluded in a seminar given to the GSK Cell and Gene Therapy team Prior to the Centre the team had worked with ReNeuron to develop an automated process for manufacture of their lead clinical cell line, CTX, currently in Phase I/II trials for stroke therapy. The Centre went on to collaborate with ReNeuron to define a robust upstream process for production of CTX cells that would enable delivery at phase III clinical trial and market scale. This relationship continues to grow with a pipeline of work planned to support ReNeuron's large scale clinical manufacture. Baker Ruskinn played a pivotal role in two CIM projects in addition to contributing to the Mid-term Review. Projects which befitted directly from Baker Ruskinn participation were the Hypoxycool project and the Invertebral disc engineering project. Baker Ruskinn have now licensed the Hypoxycool IP from Keele University and have subsequently developed a commercially-available product. The intervertebral disc project stimulated a technology redesign within Baker Ruskinn such that their hypoxia workstation can now incorporate flexibility to accommodate bioreactor products. Asymptote is a globally-significant specialist company delivering cryogenic equipment to the industry. The CIM has built an excellent relationship with Asymptote and this has resulted in a successful bid for InnovateUK funding to develop a bioartificial liver device. The Centre and UCL have worked hard to sustain a strategic relationship. This is evidenced by a number of joint proposals and more particularly by the Joint UCL-Loughborough bid for the Cell Therapy Catapult. This made it to the final interview stage as one of three candidates. More recently the 2014 Loughborough-UCL bid for an EPSRC Manufacturing Hub (Medcalf and Velayudhan) passed the EOI stage. The work of remedi and more recently the CIM has supported and given context to the doctoral training activity. A successful start to the DTC programme led to the award of an E-TERM (Engineering Tissue Engineering and Regenerative Medicine) EPSRC Landscape Programme, bringing together for the first time the six University DTC teams (Loughborough, Nottingham, Keele, Leeds, Sheffield and York). This programme provided an opportunity to combine the research strengths of the six institutions to deliver a strategic collaborative programme of cross-disciplinary research, and to further develop a cohort of future multidisciplinary research leaders. Twelve Early Career Fellows have been appointed to date, located at Sheffield, York, Keele, Nottingham and Loughborough universities, of which eight have now completed their individual research programmes. The CIM has assisted Innogen with their recent surveys and report to BSi relating to Standards and Regulations for advanced therapeutics. The work at Innogen and at the CIM is complementary in the area of viable business models for the sector and currently Joyce Tait, Geoff Banda and Nick Medcalf are planning a collaborative workshop with industry and clinicians on this topic for later in 2016. The relationship between the Centre and the MHRA has been very strong and we will continue to nurture this pathway to impact. John Wilkinson (Director of Devices, MHRA) is using the CIM 3D bioprinting paper within MRHA as a benchmark for ways of working to inform regulation in this area. Ian Rees (MHRA Inspectorate) is a regular correspondent in meetings informal and formal and has contributed valuable insights to the research. The Centre occupies an important position in the emerging standards and guidance via BSi. On the international stage the Centre has a leading role in the regenerative medicine work of ISO Technical Committee 276 (Bioprocessing), working alongside BSi and LGC. In November 2015 a workshop was held at Loughborough at the request of the Japanese delegation and convener (Heki, Tatsuo of FIRM) to examine the topic of 'manufacturability' i.e. that property of well-designed cell processes that can provide out-scalable manufacture. Nick Medcalf is leading this activity which will result in a white Paper in 2016 co-produced by the Japanese, US, UK and South Korean delegates. Keele University (El Haj) has been an important contributor to EMA initiatives such as the 2012 Workshop on Focus Groups: a model for fruitful interaction between the CAT and its interested parties. The Centre has also been active within the European Regulatory area through an initiative with EATRIS. In 2015 a joint meeting was held with the European Medicines Agency at Canary Wharf with the objective of introducing the Centre/EATRIS initiative in distributed manufacturing. An invitation has been extended by the EMA for Loughborough to put key research questions to the Committee for Advanced Therapeutics in 2016 which could result in cooperative effort to establish a collaborative program of work in EMA priority areas. The CIM provided written and oral evidence to the 2012 - 2013 House of Lords Science and Technology Committee Inquiry into Regenerative Medicine. The oral evidence was focussed on manufacturing and was sought from a panel made up of David Newble of TAP Biosystems, Keith Thompson CEO of the CGTC and David J Williams of Loughborough [HoL 2013]. The House of Lords Inquiry led to the formation of the Regenerative Medicine Expert Group in order to address the key issues identified. David Williams was on the expert group. The Centre made particular contributions to the Regulation and Licencing Subgroup (via Williams, Medcalf and Chandra) in particular using evidence of the complexity of near-patient processing issues to signal regulatory issues [RMEG 2014]. The joint Innovate-MRC Biomedical Catalyst has been the major national intervention to support medical technology innovation in industry and was put in place as a consequence of the downturn. David Williams served as a member of its Major Awards Committee. The Centre has occupied a strategic role in the international research and policy community in regenerative medicine. The items below are illustrative. One of the most significant translational centres internationally is CCRM (the Canadian Centre for Regenerative Medicine). The Centre has cultivated and continues to cultivate a strategic relationship with CCRM. Significantly Michael May, the CCRM CEO, led the mid-term review. The Centre and CCRM have collaborated in particular by means of DTC/CDT student secondment and co-publishing especially on adoption issues [Rose 2012]. The CIM has focussed on ISCT (The International Society for Cell Therapy) as a key international target for both dissemination and influencing. Activities with ISCT have included regular attendance at US and International ISCT conferences, the use of the Society Journal, Cytotherapy, as the destination for policy influencing "white" papers, and by actively contributing to the work of the Society's Commercialisation Committee (Williams). As part of building a strategic relationship with the Boston Area, a number of discussions have been held with the MIT Centre for Biomedical Innovation. These culminated in the invitation of three Centre researchers (Williams, Thurman-Newell, McCall) to give presentations (including a keynote) at the 2015 Biomanufacturing Summit. Discussions are proceeding with MIT on areas for future collaboration. Importantly MIT are shaping their own research activity to focus on analytical techniques taking account of the UK capabilities in processing developed in the Centre. There is a significant interest in manufacturing strategy and the enablers for the distribution of manufacturing. Through the Centre Outreach program there is an ongoing relationship between the Centre and the Harvard Stem Cell Institute. Arianna Rech, a Chemical Engineering undergraduate student from Loughborough, was awarded an internship at the Wyss Institute at Harvard University (Don Ingber's Laboratory) to assist with development of 'Bone Marrow on a Chip'. The purpose is to provide a test platform for understanding disease and the effects of radiation on bone health. A study led from Keele (Forsyth, El Haj) gave a high impact demonstration of near patient cell processing. The study mapped and observed the transfer of a leading edge regenerative medicine product from the industrial development setting into delivery application within a UK hospital. Working in collaboration with key stakeholders, the NHS, the Stroke Research Network, and a significant regenerative medicine industry partner (the American company Athersys), the researchers evaluated the ease of transition of a cell-based product into a UK hospital setting. The product was targeted for the treatment of an acute neurological disorder. The primary outcome of the evaluation was that the UK hospital setting can successfully integrate manufactured cell-based regenerative medicine products into the healthcare delivery platform. There are, however, substantial baseline requirements for this to be met. These include the onsite localisation of GMP grade clean rooms (with Class A handling), 24/7 readiness and coordinated lines of communication from patient to processor. The French AFM-Telethon and the Sociétés de Projets Industriels equity fund headed by the Banque publique d'investissement are investing in the creation of the largest European centre for the development and manufacturing of gene and cell therapies with a planned size of 13,000 m2 in Evry, France. To reach industrial scale, the facility will be equipped with the latest automation equipment including platforms for the expansion of stem cells. The EPSRC Centre has been collaborating with I-Stem, France in the EP051 automation project. Researchers from the EPSRC Centre (Chandra, Williams) are currently working with the I-Stem to specify the automation platform(s) and use their experience for validation to produce therapeutics. One of the European major centres for the automation of cell and tissue processing is FhG-IBMT. This organisation is also investing in the Babraham Science Park. Loughborough is working in collaboration with FhG-IBMT via the UKRMP PSCP Partnership Project on automated cell culture comparability, an opportunity that has arisen through the positional work in the CIM on automation. In addition to the ISO work detailed above the Centre has applied funding from the Sasakawa Foundation to enable two researchers (Hao Zhang and Tom Heathman) to make trips to Japan to build links with relevant research groups in Osaka, Kyoto, Tokyo and Tsukuba. The CIM has established strong links with SIMTech (Singapore) via the researcher May Win-Naing and this important near-patient cell processing link will continue to play an important role in the future. 3. Outreach The CIM has played an important role in providing trainees for the future, in raising public awareness and in providing for regulatory development for the sector. The CIM has provided two fully funded undergraduate internships at Harvard Stem Cell Institute, strengthening the relationship between UK and US institutions. Following their experiences, the first candidate is undertaking a PhD and the second secured funding to return to HSCI and will apply for a PhD on their return. The CIM supported training of four undergraduate medical students to take part in the INSPIRE programme at Keele University. It combined the CIM's target areas of commercial engagement, training of the next generating and raising awareness of careers in regenerative medicine sector. To promote the CIM's activities, a monthly/bi-monthly newsletter was distributed to more than 500 subscribers including industrial contacts, lead academics and researchers. The CIM institutions will continue to communicate with the established database to inform stakeholders of future projects and events. Through the CIM, the Healthcare Engineering and Regenerative Therapies (HEART) programme has been formed to bring regenerative medicine, science and engineering to learners of all ages. The CIM and HEART group has been invited to exhibit at more than 10 events over the past two years, to communicate the centre's research to members of the public. Notable events include Big Bang Fayre, Birmingham & London, Cheltenham Science Festival, Cheltenham and Imagineering, Coventry. A HEART blog has been established, aimed at school age readers, which delivers accessible research to learners, in addition to providing suitable classroom material for teachers. The blog attracts 100+ views per day with up to 92% being new users. In addition to the larger exhibitions, the team have also run tailored workshops in schools. The HEART team is comprised of CIM researchers, DTC/CDT researchers and E-TERM fellows. Continuity of research communication will be maintained through the two latter groups. A total of four projects have been funded at approximately £40k each as a result of thematic sandpit events held by the CIM. Researchers at the universities at Bath (Modular manufacturing of bone), Newcastle (Wave-based panning for pancreatic islets), Birmingham (ElectroStim optic nerve scaffolds) and UCL (Magnetic patterning of cells for hollow organ tissue engineering) have conducted focused projects awarded on a competitively-funded basis. A significant component of the outreach activity was to support the development of promising early career researchers outside the core partners. Four researchers were particularly identified: Liam Grover (Birmingham), Marianne Ellis (Bath), Lucy Foley (Formerly of Newcastle), and Ivan Wall (UCL). These were encouraged to form a network and to "raise their game" by exposure to the Boston innovation system in a one week visit. The relationships have been sustained and grown particularly in the cases of Grover and Wall. The network was actively encouraged to participate in the Sandpit activities as above. One of the core challenges for any centre of excellence is to decide how it manages the interface with Europe and EU Funding as this can be resource hungry with comparatively little return. A strategic decision was therefore made to interact via a translational organisation, EATRIS, and to have a particular focus on regulatory issues and to leverage the EATRIS relationship with the EMA (European Medicines Agency) as noted above. This is ongoing. 4. IP generation A major focus of the CIM has been the securing of intellectual property through patents and through know-how. The patents are listed elsewhere in ResearchFish and range over equipment, instruments and materials. 5. Leverage Selected Leveraged Projects in addition to those described already include: UK Regenerative Medicine Platform: Confirming that EPSRC Centre partners are major players in UK regenerative medicine research, Centre academics are involved in three of the five Hubs. This includes directing the Acellular (smart material) Hub which provides approaches for therapeutic delivery (Kevin Shakesheff, University of Nottingham) and contribution from an EPSRC Centre member within the core team (Alicia El Haj, Keele University). The Stem Cell Niche Hub is supported by EPSRC Centre member (El Haj). The Cell Behaviour, Differentiation and Manufacturing Hub - Pluripotent Stem Cell Platform (PSPC) includes EPSRC Centre members within its core team (David Williams, Robert Thomas, Nick Medcalf, Loughborough University). As part of a DARPA-funded consortium led by Celgene Cellular Therapeutics, in close partnership with TAP Biosystems, EPSRC Centre members have cultured haematopoietic progenitor cells derived from umbilical cord through an expansion and erythroid lineage commitment process to test and engage in process development programmes. This project led to two additional complementary investments. The first was an EPSRC Early Career Fellowship for Rob Thomas. The second utilised funding from the EPSRC Centre and the Wellcome Trust to collaborate with an existing Wellcome Trust-funded consortium seeking to produce red blood cells in the laboratory. The consortium comprises The University of Bristol, The University of Edinburgh, The University of Glasgow, NHS Blood and Transplant, the Scottish National Blood Transfusion Service, the Irish Blood Transfusion Service and Roslin Cells. The TSB Regenerative Medicine Value Systems and Business Models project: 'Navigating the Uncertainties' was designed to address the entire value system of regenerative medicine by taking a perspective encompassing four key uncertainties: Technological - Product, Process and Supply; Regulatory - Status and Application; Reimbursement - Public and Private and Financial - Business and Investment models. This research has been cited in the 'The case for public support of innovation: At the sector, technology and challenge area levels' report published by the UK Government's Department of Business, Innovation and Skills (2014). 6. Continuity The CIM has been the location for effective career progression and continuity in research. Melissa Mather, a key researcher at Nottingham, was made Professor of BioMedical Imaging at Keele University in recognition of her work on medical imaging. During the period of the Centre Rob Thomas was awarded an early career Fellowship to develop processes and technologies for haematopoietic cell products. (He has also been awarded a Readership in Manufacturing for Cell-Based Therapies.) In conjunction with a Wellcome Trust award to develop manufacturing processes for first in man clinical studies with red blood cells this enabled a group to be established working on process control and characterisation for a specific and high value set of near market products. This work continues to evolve with new process development approaches and further products such as platelets and immunotherapies. Nick Medcalf transferred from the Smith & Nephew Research Centre, York, in 2013 as an EPSRC Manufacturing Fellow and took up the post of CIM Director in 2014 from Dave Williams. Nick brings a strong systems focus to the research work and is also now representing industry readiness training for the CDT offering. A number of research assistants and associates and DTC students involved in CIM projects have now secured lectureships: Liz Ratcliffe and Mark McCall (Loughborough), Lisa White (Nottingham) and Arum Saeed (UEA). Significantly the scale and visibility of the activity has also drawn in internationally recognised translational researchers to UK academic positions in particular Alexandra Stolzing, now a Senior Lecturer in Loughborough, from FhG-IZM, Leipzig. A characteristic of the Centre has been its commercial orientation. The research program and the ethos resulted in three enterprise fellowships. Dr Alex Lyness is an Enterprise Fellow at Loughborough University and funded via EPSRC IAA awarded by the LU Enterprise Office. His work is focused on identifying the needs and requirements of enabling technologies to deliver the cell-based therapies to patients in the clinic. In his role Alex is developing his research in the field of cell delivery into a device ready for IP protection by the end of the Fellowship and has also conducted work for the Cell Therapy Catapult, where he is the Technical Lead on project to develop an intradermal delivery device to deliver a cell-based therapy. Mark McCall held the first EPSRC Impact Acceleration Account funded Enterprise Fellowship at Loughborough University working on commercially exploitable projects with both UK based SME's and multinationals. The fellowship focused on novel approaches to cost reduction in bioprocess manufacturing and development through process improvement and technology innovation. During the first 20 months of the 24-month fellowship Mark took a novel scaled expansion bioreactor technology from an early demonstration system to a medium-scale operational prototype, which led to extensive due diligence with a leading developer of bioprocess tools and platforms. He also supervised complex technical and process development activities for commercial clients including multiples processes and products intended for clinical use within the next two years. Elizabeth Ratcliffe, a researcher within the CIM, was awarded an EPSRC Impact Acceleration Enterprise Fellowship (£140k): 'Developing Synthetic Biology strengthened tools for Gene Therapy translation'. This was a competitive 16 month Enterprise Fellowship in Synthetic Biology breaking new ground for Loughborough University, working on challenge-led translational science and technology development in collaboration with Dr Michael Roberts, CSO and founder of Synpromics Ltd. (a leading Synthetic Biology platform technology company) and Professor Michael Linden, Professor of Virology, University College London / Pfizer. The project involves developing synthetic biology-strengthened cells and viral vectors for gene therapy research and combining this with scalable automated manufacturing methods and process development methods for HEK293T cell expansion and transfection to make informed advancements in the bioprocess development and scaling of gene therapy manufacture. 7. New directions The CIM, its predecessor remedi, and the related grant portfolios including the DTC and CDT have resulted in the development of an internationally distinctive capability in regenerative medicine manufacturing with a hub at Loughborough. Importantly this has been consolidated and is now sustained by a large group of permanent academic staff funded via new national and university initiatives in particular HEFEC Catalyst funding and Vice Chancellor's Lectureships and with EPSRC Fellowship support. The market research that was conducted in order to make the two bids for EPSRC Future Manufacturing hubs has provided the Centre with clear directions for future research. These concentrate around the subject of control, systems engineering and improved methods for ensuring reproducibility of processes, site-to-site and between teams. Some of this work is now being developed in the UKRMP project. The remainder will be re-examined and used to form the basis of single-theme applications for funding with co-production from our industry collaborators. The subject of systems analysis and technology gaps comes together in the current work on re-distributed manufacturing. By means of work at the management level for the network and in the feasibility studies for microfactories and bioprinting the CIM will exert leadership in influence over future research directions for the EPSRC and the ESRC. Recommendations are due by the end of 2016. A strategically-important spin-off study from the CIM in the regulatory/systems area has been the study of the implementation of 'Optimed-ID', an automated medicines dispensing platform at Leicester General Hospital. The system is being assessed for its impact on medicines costs across the four renal wards by removing losses in-system and improving ordering precision. LU has reported on the system to the committee chaired by lord Carter of Coles and also to the Department of Health. The work is expected to generate opportunities for integrating fresh-preserved medicines in this rapid and fully-traceable supply chain system. It has become increasingly clear as the CIM has evolved that there is a requirement to get closer to clinical adopters in particular to determine product quality requirements and that Defence Medicine has a history of being a first mover innovator adopter in transformative medical approaches and technologies. These combined with the success of the Loughborough involvement in the DARPA Blood project and the recent £300M investment in the Defence and National Rehabilitation Centre at Stanford Hall has led to an increased focus on defence medical requirements at Loughborough. David Williams is university academic lead on Defence Medicine. 8. Operational learning and management organisation The Centre was led from Loughborough University by Prof David William as Director and PI for the research and supported by a Deputy Director (Dr Rob Thomas) and a Programme Manager (Dr Paul Hourd) in partnership with complementary groups at Keele University and The University of Nottingham. Having some degree of external governance and oversight of the Centre is an integral part of EPSRC's requirements, a Board was appointed as the primary vehicle for delivering that governance and ensuring that output from the Centre was of high quality and met the deliverables outlined in the proposal. The Board, chaired by Richard Archer (an industrialist), comprised the most senior and experienced members of the Executive and four 'non-executive' members, appointed by the major collaborators in addition to an EPSRC representative. An Executive Committee was also appointed to manage the operational aspects of the programme, which incorporated a research portfolio management process to provide visible budget, resource and new proposal review as well as the phase-gated project management of selected major research projects. This Executive Committee comprised the major academic theme/project leaders from Loughborough, Keele and Nottingham, including the Programme Manager. Both the Board and the Executive Committee met formally four times per year. Minutes of the meetings were recorded and issued within 1 week of the meeting with all actions traceable to completion or closure. A confidential Register of Interests was maintained to ensure that potential conflicts were transparent to and recognised by the Board. Applied to individual elements and across the whole programme, this structure provided a robust (and academically atypical) management approach, which together with strong leadership from the Chairman and Director, was very important to ensuring good governance and the delivery of high value Centre outcomes. 9. CDT interface Several DTC/CDT students, including Peter Archibald and Mark McCall, have contributed to CIM projects. Furthermore, the CIM and the DTC/CDT in Regenerative Medicine have worked closely together on a number of initiatives including joint outreach campaigns. For example, the HEART blog started by Sophie Dale-Black, Head of Engagement at the CIM, is now run by a CDT student. Involvement with the DTC/CDT has also highlighted a gap between the amount of multi-disciplinary training provided for PhD students working in this sector and that which we provide for our RAs. This shortfall is something PIs within the CIM, through their own RAs and by influencing the Universities and research councils are continuing to address. It is important to recognise the support that remedi and the CIM have received from the EPSRC. The Loughborough team under the leadership of Prof David Williams has managed, in a competitive research environment, to secure and leverage investments and support for the CDT Interface. This vital strategic support has enabled the Loughborough/Keele/Nottingham research teams to co-ordinate activity from the CDT, the CIM, ETERM and the Fellowships to give research synergy and to establish critical mass for the research portfolio. 10. CGTC interface The presence of the Cell and Gene Therapy Catapult in the UK research system has given a powerful boost to the UK advanced therapeutics translational capability. The influence of the CGTC upon the CIM has been largely positive and we must be careful to manage the unique position of the CGTC in terms of the impact that it has upon the role and profile of the Centre. The CIM Management has been aware that with the new CGTC facility in London and the production site being built in Stevenage there is now a perception amongst grant reviewers that the UK has all the investment that it currently needs in the subject of regenerative medicine manufacturing research. There is, however, still a role for the creation of enabling technology upstream of the CGTC and this is recognised by that organisation. 11. Summary The CIM has built on the achievements of its forerunner, remedi, and continues to play a leading role in the UK regenerative medicine research system that will endure beyond its term of funding through the excellence of its published science, a rich people pipeline, policy influence and leveraged funding activity. 12. Additional information in 2017 The activity of the CIM in automated manufacturing of cell therapies, as reported by, in particular, Dr Amit Chandra, Prof. David Williams, Dr Robert Thomas, Dr Peter Mitchell and Dr Peter Archibald, attracted the attention of I-STEM (Evry, France) and, as a consequence of the close support that has been given by Dr Amit Chandra to I-STEM over the last twelce months, Dr Chandra departed the Loughborough Laboratories in December 2016 to take up the post of Business Development Manager at I-STEM. This important appointment at the Banque de la Republique-funded labs in France demonstrates the importance of the CIM in providing industry-relevant research and capability to major international ventures.
First Year Of Impact 2013
Sector Healthcare,Manufacturing, including Industrial Biotechology,Pharmaceuticals and Medical Biotechnology
Impact Types Societal,Economic
 
Description House of Lords Inquiry
Geographic Reach National 
Policy Influence Type Contribution to a national consultation/review
Impact David Williams gave oral evidence to the House of Lords Science and Technology Committee for their Inquiry into regenerative medicine focussing on both clinical and economic impacts. EPSRC Centre's research and impact noted in paragraph 96 of the report, including a reference to testing and validation of a project with Instron TGT investigating a prototype hydrostatic pressure growth chamber. David Williams has joined the Regenerative Medicine Expert Group that was formed after the publication of the House of Lords report. This is focussed on improvements in clinical services.
URL http://www.publications.parliament.uk/pa/ld201314/ldselect/ldsctech/23/23.pdf
 
Description Regenerative Medicine Expert Group
Geographic Reach National 
Policy Influence Type Citation in other policy documents
URL https://www.nice.org.uk/Media/Default/About/what-we-do/Research-and-development/regenerative-medicin...
 
Description A hub for engineering and exploiting the stem cell niche
Amount £17,488 (GBP)
Funding ID MR/K026666/1 
Organisation Medical Research Council (MRC) 
Sector Public
Country United Kingdom
Start 06/2013 
End 05/2017
 
Description Additional Funds to EPSRC Centre for Innovative Manufacturing in RM
Amount £65,914 (GBP)
Funding ID EP/H028277/1 
Organisation Engineering and Physical Sciences Research Council (EPSRC) 
Sector Public
Country United Kingdom
Start 10/2012 
End 08/2015
 
Description Arthritis Research UK Tissue Engineering Centre
Amount £713,417 (GBP)
Funding ID 19429 
Organisation Versus Arthritis 
Sector Charity/Non Profit
Country United Kingdom
Start 04/2011 
End 04/2016
 
Description BIODESIGN: Rational Bioactive Materials Design for Tissue Regeneration
Amount £348,000 (GBP)
Funding ID 262948-2 
Organisation European Commission 
Sector Public
Country European Union (EU)
Start 01/2012 
End 12/2016
 
Description Bar-Coded Biomaterials
Amount £308,637 (GBP)
Funding ID EP/H005625/1X 
Organisation Engineering and Physical Sciences Research Council (EPSRC) 
Sector Public
Country United Kingdom
Start 07/2012 
End 07/2016
 
Description Bioprocessing Research for Cellular products
Amount £325,501 (GBP)
Funding ID BB/I017062/1 
Organisation Biotechnology and Biological Sciences Research Council (BBSRC) 
Sector Public
Country United Kingdom
Start 02/2011 
End 02/2014
 
Description Construction of a miniaturized human lymph node model as an alternative to the Local Lymph Node Assay
Amount £60,000 (GBP)
Funding ID NC/K500318/1 
Organisation National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs) 
Sector Public
Country United Kingdom
Start 09/2012 
End 08/2016
 
Description Contract Process Development
Amount £535,000 (GBP)
Organisation Cell Therapy Catapult 
Sector Charity/Non Profit
Country United Kingdom
Start 08/2013 
End 06/2015
 
Description Defining the mechanisms on anti-inflammatory and chondroprotective effects of MSCs in arthritis
Amount £12,000 (GBP)
Organisation Institute of Orthopaedics 
Sector Charity/Non Profit
Country United Kingdom
Start 05/2013 
End 11/2013
 
Description Developing generic scaleable and standardised selection methods for human therapeutic cells
Amount £452,430 (GBP)
Funding ID BB/I017143/1 
Organisation Biotechnology and Biological Sciences Research Council (BBSRC) 
Sector Public
Country United Kingdom
Start 02/2011 
End 02/2014
 
Description E-TERM
Amount £2,884,739 (GBP)
Funding ID EP/I017801/1 
Organisation Engineering and Physical Sciences Research Council (EPSRC) 
Sector Public
Country United Kingdom
Start 04/2012 
End 03/2018
 
Description EPSRC Fellowships in Manufacturing - Regenerative Medicine Manufacture: A Systems Based Research Platform
Amount £887,759 (GBP)
Funding ID EP/K037099/1 
Organisation Engineering and Physical Sciences Research Council (EPSRC) 
Sector Public
Country United Kingdom
Start 08/2013 
End 11/2018
 
Description EPSRC Impact Acceleration Account
Amount £139,000 (GBP)
Organisation Engineering and Physical Sciences Research Council (EPSRC) 
Sector Public
Country United Kingdom
Start 09/2014 
End 09/2015
 
Description EPSRC National Centre
Amount £534,000 (GBP)
Funding ID EP/H028277/1 
Organisation Engineering and Physical Sciences Research Council (EPSRC) 
Sector Public
Country United Kingdom
Start 04/2012 
End 08/2015
 
Description Enduring Challenge Competition (human performance - medical)
Amount £98,147 (GBP)
Funding ID DSTLX1000088675 
Organisation Defence Science & Technology Laboratory (DSTL) 
Sector Public
Country United Kingdom
Start 06/2014 
End 11/2015
 
Description Engineering Biological Science-Processes and Systems for Haematopoietic Stem Cell Based Therapy Manufacture
Amount £1,294,482 (GBP)
Funding ID EP/K00705X/1 
Organisation Engineering and Physical Sciences Research Council (EPSRC) 
Sector Public
Country United Kingdom
Start 09/2013 
End 09/2018
 
Description Equipment purchase of BD Jazz Cell Sorter
Amount £154,000 (GBP)
Organisation Loughborough University 
Sector Academic/University
Country United Kingdom
Start 07/2013 
End 08/2013
 
Description Fully Funded Studentship - Uni of Kurdistan Hewler
Amount £55,000 (GBP)
Organisation University of Kurdistan Hewler 
Sector Academic/University
Country Iraq
Start 10/2012 
End 09/2014
 
Description Grant from Anne Duchess of Westminster Charity
Amount £1,500 (GBP)
Organisation Anne Duchess of Westminster Charity 
Sector Charity/Non Profit
Country United Kingdom
Start 01/2014 
End 02/2014
 
Description High resolution live cell imaging tool for early predication of cell quality and safety
Amount £59,468 (GBP)
Organisation University of Nottingham 
Sector Academic/University
Country United Kingdom
Start 03/2013 
End 09/2013
 
Description KTA: Supporting the Establishment and Validation of a Regulated Manufacturing Facility for Contract Research and Manufacturing of Cell Therapies
Amount £141,694 (GBP)
Organisation Engineering and Physical Sciences Research Council (EPSRC) 
Sector Public
Country United Kingdom
Start 06/2011 
End 07/2012
 
Description KTA: Supporting the Improvement and Optimisation for Cell Culture for Regenerative Medicine Products Companies
Amount £91,403 (GBP)
Organisation Engineering and Physical Sciences Research Council (EPSRC) 
Sector Public
Country United Kingdom
Start 01/2011 
End 07/2012
 
Description KTA: Supporting the Regulation and Reimbursement of Regenerative Medicine Products in the UK
Amount £50,291 (GBP)
Organisation Engineering and Physical Sciences Research Council (EPSRC) 
Sector Public
Country United Kingdom
Start 09/2010 
End 04/2012
 
Description MRc UKRMP Aceleular Delivery Hub
Amount £750,000 (GBP)
Organisation Medical Research Council (MRC) 
Sector Public
Country United Kingdom
Start 04/2014 
End 04/2018
 
Description Medical Research Grant
Amount £98,000 (GBP)
Organisation The Dowager Countess Eleanor Peel Trust 
Sector Charity/Non Profit
Country United Kingdom
Start 12/2013 
End 12/2015
 
Description Modifications to CBE laboratories to increase capacity
Amount £131,000 (GBP)
Organisation Loughborough University 
Sector Academic/University
Country United Kingdom
Start 06/2013 
End 07/2013
 
Description Nottingham Catalyst Partnership Fund
Amount £500 (GBP)
Organisation University of Nottingham 
Sector Academic/University
Country United Kingdom
Start 10/2014 
End 12/2014
 
Description Rational Bioactive Materials Design for Tissue Regeneration
Amount £402,880 (GBP)
Funding ID 262948-2 
Organisation European Commission 
Sector Public
Country European Union (EU)
Start 01/2012 
End 01/2016
 
Description Redistributed Manufacturing in Healthcare Network - Feasibility Studies
Amount £49,000 (GBP)
Funding ID EP/M017559/1 
Organisation Engineering and Physical Sciences Research Council (EPSRC) 
Sector Public
Country United Kingdom
Start 11/2015 
End 04/2016
 
Description Research Fellowships Scheme (Marianne Ellis)
Amount £47,137 (GBP)
Organisation Royal Academy of Engineering 
Department The Leverhulme Trust/Royal Academy of Engineering
Sector Charity/Non Profit
Country United Kingdom
Start 06/2014 
End 05/2015
 
Description Research Grant
Amount £12,000 (GBP)
Funding ID RPG 139 
Organisation Institute of Orthopaedics 
Sector Charity/Non Profit
Country United Kingdom
Start 01/2014 
End 01/2016
 
Description Self assembling liposome nano-transducers
Amount £733,386 (GBP)
Funding ID EP/J001953/1 
Organisation Engineering and Physical Sciences Research Council (EPSRC) 
Sector Public
Country United Kingdom
Start 10/2011 
End 10/2016
 
Description Sensor integrated Bioreactors (SIBs)
Amount £402,995 (GBP)
Funding ID 101101 
Organisation Innovate UK 
Sector Public
Country United Kingdom
Start 03/2012 
End 03/2014
 
Description Stem Cells as Therapeutic Agents in Arthritis
Amount £98,735 (GBP)
Organisation The Dowager Countess Eleanor Peel Trust 
Sector Charity/Non Profit
Country United Kingdom
Start 04/2013 
End 11/2013
 
Description Stuart Jenkins Fellowship
Amount £185,000 (GBP)
Funding ID EP/I017801/1 
Organisation Engineering and Physical Sciences Research Council (EPSRC) 
Sector Public
Country United Kingdom
Start 10/2012 
End 09/2014
 
Description Supporting regenerative medicine and cell therapies
Amount £922,367 (GBP)
Funding ID 32065-222136 
Organisation Innovate UK 
Sector Public
Country United Kingdom
Start 08/2014 
End 07/2017
 
Description UK Regenerative Medicine Platform Hub: Acellular
Amount £3,499,345 (GBP)
Funding ID MR/K026682/1 
Organisation Medical Research Council (MRC) 
Sector Public
Country United Kingdom
Start 09/2013 
End 08/2017
 
Description Wellcome Trust Translational Scheme
Amount £583,461 (GBP)
Organisation Wellcome Trust 
Sector Charity/Non Profit
Country United Kingdom
Start 10/2013 
End 04/2017
 
Description skelGEN
Amount £21,000 (GBP)
Funding ID 318553 
Organisation European Commission 
Sector Public
Country European Union (EU)
Start 12/2012 
End 11/2016
 
Title ECP023 Characteristics of Cells 
Description MSCs that differentiate towards cartilage formation are potentially associated with the higher performing cell population in our pre-clinical model. This information could be used as design input to a further study to test/validate these relationships. 
Type Of Material Model of mechanisms or symptoms - mammalian in vivo 
Year Produced 2014 
Provided To Others? Yes  
Impact Our pre-clinical model over a short time period allows assessment of input and output variables to be measured and assessed linked to manufacturing expertise to define cell parameters for quality markers. 
 
Title Identification of Subpopulations within Mesenchymal Stem Cell Cultures 
Description We have discovered a novel technique that could measure this osteogenic potential from a small marrow sample. The same technique can subsequently separate and enrich the population of highly osteogenic cells from the full cell population. 
Type Of Material Technology assay or reagent 
Year Produced 2014 
Provided To Others? Yes  
Impact Patentability of the technique is currently being evaluated. 
 
Description ECP001 - TAP Biosystems 
Organisation TAP Biosystems
Country United Kingdom 
Sector Private 
PI Contribution Efficient (next generation) Manufacturing Platform for adherent allogeneic cell therapies
Start Year 2010
 
Description ECP002 - Syngenta 
Organisation Syngenta International AG
Country Switzerland 
Sector Private 
PI Contribution Development of a Tissue Engineered 3D in vitro lymph node model. Syngenta have expressed an interest in the development of an in vitro model of human lymph node as it has direct relevance to their industry. Although not providing any financial contribution to the studentship, they are providing academic expertise through attendance at quarterly supervisor meetings.
Start Year 2012
 
Description ECP002 - Unilever 
Organisation Unilever
Country United Kingdom 
Sector Private 
PI Contribution Development of a Tissue Engineered 3D in vitro lymph node model
Start Year 2010
 
Description ECP002 - University of Leeds 
Organisation University of Leeds
Country United Kingdom 
Sector Academic/University 
PI Contribution Development of a Tissue Engineered 3D in vitro lymph node model. In order to enhance the permeability of the scaffolds being used for this project to the cells being used for model development, we used an ultrasound treatment developed and conducted at Leeds University.
Start Year 2010
 
Description ECP003 - Smith & Nephew 
Organisation Smith and Nephew
Country United Kingdom 
Sector Private 
PI Contribution Near Patient Cell Processing, Phase 1: Enabling manufacturing & supply of cell therapies in hospital settings
Start Year 2010
 
Description ECP003 - TAP Biosystems 
Organisation TAP Biosystems
Country United Kingdom 
Sector Private 
PI Contribution Near Patient Cell Processing, Phase 1: Enabling manufacturing & supply of cell therapies in hospital settings
Start Year 2010
 
Description ECP003 Anthony Nolan 
Organisation Anthony Nolan Cell Therapy Centre
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution Mapping processes
Start Year 2010
 
Description ECP003 Dana Farber Cancer Institute 
Organisation Dana-Farber Cancer Institute
Country United States 
Sector Hospitals 
PI Contribution Developing research opportunities
Collaborator Contribution Access to comprehensive data on biological variation in a key clinical procedure including manufacturing steps.
Impact Multi-disciplinary spanning medicine, biology and engineering.
Start Year 2011
 
Description ECP003 FHT 
Organisation Future Health Technologies
Country United Kingdom 
Sector Private 
PI Contribution Mapping processes
Start Year 2010
 
Description ECP003 Oswestry Hospital 
Organisation Oswestry Hospital
Country United Kingdom 
Sector Hospitals 
PI Contribution Developing research opportunities
Start Year 2010
 
Description ECP003 QMC 
Organisation Nottingham University Hospitals NHS Trust
Department Pathology Department
Country United Kingdom 
Sector Hospitals 
PI Contribution Mapping processes
Start Year 2010
 
Description ECP003 UCL Institute of Opthamology 
Organisation University College London
Department Institute of Ophthalmology UCL
Country United Kingdom 
Sector Academic/University 
PI Contribution Developing research opportunities and mapping processes
Start Year 2010
 
Description ECP004 - Ludwig Boltzmann Institute 
Organisation Ludwig Boltzmann Society
Department Ludwig Boltzmann Institute for Experimental and Clinical Traumatology
Country Austria 
Sector Academic/University 
PI Contribution A new 3D delivery platform for regenerative medicine
Start Year 2011
 
Description ECP004 - McGowan Institute 
Organisation University of Pittsburgh
Country United States 
Sector Academic/University 
PI Contribution A new 3D delivery platform for regenerative medicine
Start Year 2012
 
Description ECP004 - RegenTec 
Organisation Regentec
Country United Kingdom 
Sector Private 
PI Contribution A new 3D delivery platform for regenerative medicine
Start Year 2011
 
Description ECP005 - Moorfields Eye Hospital 
Organisation Moorfields Eye Hospital NHS Foundation Trust
Country United Kingdom 
Sector Public 
PI Contribution Label Free Assessment of Live Cell Quality with Total Internal Reflection Microscopy
Start Year 2012
 
Description ECP005 - National Physical Laboratory 
Organisation National Physical Laboratory
Country United Kingdom 
Sector Academic/University 
PI Contribution Label Free Assessment of Live Cell Quality with Total Internal Reflection Microscopy
Start Year 2011
 
Description ECP005 - Reneuron 
Organisation Reneuron
Country United Kingdom 
Sector Private 
PI Contribution Label Free Assessment of Live Cell Quality with Total Internal Reflection Microscopy
Start Year 2011
 
Description ECP007 - Tissue Growth Technologies 
Organisation Tissue Growth Technologies
Country United States 
Sector Private 
PI Contribution Development & validation of TGT Hydrostatic Bioreactor for tissue processing and manufacturing in regenerative medicine
Start Year 2011
 
Description ECP008 - Ruskinn Technology 
Organisation Ruskinn Technology Ltd
Country United Kingdom 
Sector Private 
PI Contribution Near Patient Processing: HypOxyCool for Improved Autologous Cell Production
Start Year 2011
 
Description ECP013 - Pfizer 
Organisation Pfizer Ltd
Country United Kingdom 
Sector Private 
PI Contribution Evaluation of Functionalised Membranes for use in Immunisolatory devices for Regenerative Medicine and Cell based therapies
Start Year 2010
 
Description ECP015 - Neusentis 
Organisation Pfizer Ltd
Department Neusentis Pfizer
Country United Kingdom 
Sector Private 
PI Contribution Quality by Design (QbD) approach to risk reduction and optimisation for a unit operation of cell therapy manufacture
Start Year 2011
 
Description ECP020 - Bose 
Organisation Bose Corporation
Department Bose ElectroForce
Country United States 
Sector Private 
PI Contribution Control of human mesenchymal stem cell differentiation to a nucleus pulposus phenotype by improving the design of physiologically relevant in vitro conditions
Start Year 2011
 
Description ECP020 - Fondazione Filarete 
Organisation Fondazione Filarete
Country Italy 
Sector Private 
PI Contribution Control of human mesenchymal stem cell differentiation to a nucleus pulposus phenotype by improving the design of physiologically relevant in vitro conditions. This collaboration has included a number of secondments to take advantage of training and access to facilities: PhD Student HH from Loughborough spent three months at Fondzione Filarete 07/10/11 to 13/01/12 PhD Student AF from Loughborough spent three months at Fondazione Filarete 13/05/12 to 04/09/12 PhD Student TS from Fondazione Filarete spent two weeks at Loughborough 12/03/13 to 24/03/13 PhD Student AF from Loughborough spent two months at Fondazione Filarete 17/02/13 to 19/04/13
Start Year 2011
 
Description ECP020 - Ruskinn Technology 
Organisation Ruskinn Technology Ltd
Country United Kingdom 
Sector Private 
PI Contribution Control of human mesenchymal stem cell differentiation to a nucleus pulposus phenotype by improving the design of physiologically relevant in vitro conditions
Start Year 2011
 
Description ECP021 - Anthony Nolan 
Organisation Anthony Nolan Cell Therapy Centre
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution Near Patient Cell Processing, Phase 2: Enabling manufacturing & supply of cell therapies in hospital settings
Start Year 2012
 
Description ECP021 - TAP Biosystems 
Organisation TAP Biosystems
Country United Kingdom 
Sector Private 
PI Contribution Near Patient Cell Processing, Phase 2: Enabling manufacturing & supply of cell therapies in hospital settings
Start Year 2011
 
Description ECP022 - Ceram 
Organisation Lucideon
Country United Kingdom 
Sector Private 
PI Contribution Nano-structured zirconias as an enabling material for enhanced ceramic implants
Start Year 2011
 
Description ECP023 - Orthopaedic Institute 
Organisation The Orthopaedic Institute
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution From Science Bench to the Clinical Application: Establishing a stem cell population with consistent therapeutic behaviours ? Kehoe , Richardson, El Haj (KU)
Start Year 2011
 
Description ECP028 - University of Cambridge 
Organisation University of Cambridge
Country United Kingdom 
Sector Academic/University 
PI Contribution A Novel Method to Develop Electrospun Scaffolds with Tailored Geometries for in vitro models of Skin
Start Year 2011
 
Description ECP029 - Haemostatix 
Organisation Haemostatix
Country United Kingdom 
Sector Private 
PI Contribution In vitro optimisation and evaluation of a series of flow-able gelatin paste composites for wound healing
Start Year 2011
 
Description ECP030 - Newcastle University 
Organisation Newcastle University
Country United Kingdom 
Sector Academic/University 
PI Contribution Evaluation of Injectable scaffolds for use in accelerated anterior cruciate ligament (ACL) reconstruction
Start Year 2011
 
Description ECP031 - Cellon 
Organisation MCR Media Group
Country Israel 
Sector Private 
PI Contribution SIFT-MS Monitoring of cell growth in Cellon CELL-tainer bioreactor
Start Year 2011
 
Description ECP037 - Neusentis 
Organisation Pfizer Ltd
Department Neusentis Pfizer
Country United Kingdom 
Sector Private 
PI Contribution Optimisation of a Delivery Membrane
Start Year 2012
 
Description ECP038 - Nottingham University Hospitals NHS Trust 
Organisation Nottingham University Hospitals NHS Trust
Country United Kingdom 
Sector Academic/University 
PI Contribution Defining and manufacturing a cell therapy product for the generation of bone in spinal surgery applications
Start Year 2012
 
Description ECP038 - RegenTec 
Organisation Regentec
Country United Kingdom 
Sector Private 
PI Contribution Defining and manufacturing a cell therapy product for the generation of bone in spinal surgery applications
Start Year 2012
 
Description ECP040 - Cool Logistics 
Organisation Cool Logistics
Country United Kingdom 
Sector Private 
PI Contribution Modelling Thermal Performance of a Cold Chain Transportation System. During this project we developed and validated a computational model capable of describing, analysing and predicting the thermal performance of the Credo cold chain transportation packaging system under diverse loads and ambient conditions.
Start Year 2012
 
Description ECP043 - Neusentis 
Organisation Pfizer Ltd
Department Neusentis Pfizer
Country United Kingdom 
Sector Private 
PI Contribution Optimisation of a Delivery Membrane - Phase 2
Start Year 2012
 
Description ECP044 - Glasgow University 
Organisation University of Glasgow
Country United Kingdom 
Sector Academic/University 
PI Contribution RBC production from hESC
Start Year 2012
 
Description ECP045 - Mica Biosystems 
Organisation Mica Biosystems
Country United Kingdom 
Sector Private 
PI Contribution Development of dynamic 3D models for regenerative medicine
Start Year 2012
 
Description ECP048 - Glasgow University 
Organisation University of Glasgow
Country United Kingdom 
Sector Academic/University 
PI Contribution RBC production from hESC in scalable suspension format - Phase 2
Start Year 2013
 
Description ECP049 - Cell Therapy Catapult 
Organisation Cell Therapy Catapult
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution QbD approach to risk reduction and optimisation of CTX culture and cryopreservation manufacturing processes
Start Year 2013
 
Description ECP049 - ReNeuron 
Organisation Reneuron
Country United Kingdom 
Sector Private 
PI Contribution QbD approach to risk reduction and optimisation of CTX culture and cryopreservation manufacturing processes
Start Year 2013
 
Description ECP050 - Dr Belinda Clarke 
Organisation Innovate UK
Country United Kingdom 
Sector Public 
PI Contribution Staff time, in person meetings and discussions, TSB workshop presentations, hosting at Loughborough to showcase facilities
Collaborator Contribution Advice, Letter of Support for fellowship bid
Impact Contributed towards being awarded fellowship funding and towards meeting key Synthetic Biology figureheads (SynBiCITE directors) and industrial partnerships
Start Year 2013
 
Description ECP050 - Dr Ivan Wall 
Organisation University College London
Country United Kingdom 
Sector Academic/University 
PI Contribution Staff time, in-person meetings, joint proposal writing and maintaining the partnership
Collaborator Contribution Staff time, in-person meetings, joint proposal writing and maintaining the partnership
Impact Submitted Joint Proposal to Manufacturing the Future competition, multidisciplinary; Synthetic Biology, Regenerative Medicine, Biochemical Engineering and Manufacturing Engineering
Start Year 2014
 
Description ECP050 - Roslin Cells 
Organisation Roslin Cells Ltd
Country United Kingdom 
Sector Private 
PI Contribution Exploring the feasibility of Synthetic Biology applications in systematic engineering of cell therapies
Start Year 2013
 
Description ECP050 - SynBiCITE 
Organisation SynbiCITE
Country United Kingdom 
Sector Academic/University 
PI Contribution Staff time, in-person meetings, maintaining the partnership and progress updates
Collaborator Contribution Staff time, in person meetings, Letters of Support for fellowship funding
Impact Contributed to Fellowship award, raised Loughborough University's profile within Synthetic Biology and facilitated access to state of the art Synthetic Biology research groups
Start Year 2013
 
Description ECP050 - Synpromics 
Organisation Synpromics
Country United Kingdom 
Sector Private 
PI Contribution Generation of a collaborative Fellowship project, staff time, in-person meetings, bid writing, maintenance of the collaboration
Collaborator Contribution Staff time, meetings, technology and materials contributions, letters of support for fellowship bid
Impact Contributed to successful award of fellowship funding, multidisciplinary collaboration; Synthetic Biology, Stem Cell research, Gene Therapy research, Engineering
Start Year 2014
 
Description ECP050 - Synthace 
Organisation Synthace
Country United Kingdom 
Sector Private 
PI Contribution Staff time, in person meetings, discussions and scoping for potential collaborative research projects
Collaborator Contribution Staff time, in person meetings, discussions and scoping for potential collaborative research projects
Impact Raising profile of EPSRC Centre among Synthetic Biology Industry leaders, potential for future collaboration
Start Year 2013
 
Description ECP050 - University College London 
Organisation University College London
Department UCL Cancer Institute
Country United Kingdom 
Sector Academic/University 
PI Contribution Exploring the feasibility of Synthetic Biology applications in systematic engineering of cell therapies
Start Year 2013
 
Description ECP051 - CECS/I-STEM 
Organisation National Institute of Health and Medical Research (INSERM)
Department Institute for Stem cell Therapy and Exploration of Monogenic diseases (I-Stem)
Country France 
Sector Academic/University 
PI Contribution Create a working cell bank, perform manual and automated expansion of the hiPSC line, bank these cells and then perform quality metrics to the I-STEM metrics. In addition, these cells will be differentiated to MSCs and the cells will be tested for their quality. I-STEM have developed a protocol for the automated expansion of their hiPSC lines. They want to see whether the protocols are comparable over multiple sites and Loughborough University will be able to present them with this data.
Collaborator Contribution Cells, protocols for automated and manual expansion, telephone contact with I-STEM research staff
Impact This collaboration has led to the inclusion of Loughborough University in the I-STEM lead Horizon 2020 project
Start Year 2013
 
Description ECP051 - LGC 
Organisation LGC Ltd
Department Cell Metrology
Country United Kingdom 
Sector Private 
PI Contribution Provide cells to the research group at LGC
Collaborator Contribution Analyse the cells for differences in the automation protocols
Impact Analysis of the cells for differences in the automation protocols
Start Year 2013
 
Description ECP051 - Loughborough University 
Organisation Loughborough University
Country United Kingdom 
Sector Academic/University 
PI Contribution Process engineering and techniques enabling the automation of GMP cell culture processes
Start Year 2013
 
Description ECP051 - TAP Biosystems 
Organisation TAP Biosystems
Country United Kingdom 
Sector Private 
PI Contribution Process engineering and techniques enabling the automation of GMP cell culture processes
Start Year 2013
 
Description ECP051 - University College London 
Organisation University College London
Department UCL Cancer Institute
Country United Kingdom 
Sector Academic/University 
PI Contribution Process engineering and techniques enabling the automation of GMP cell culture processes
Start Year 2013
 
Description ECP051 - Wicell Research Institute 
Organisation Wicell Research Institute
Country United States 
Sector Charity/Non Profit 
PI Contribution Process engineering and techniques enabling the automation of GMP cell culture processes
Start Year 2013
 
Description Engagement Activity - Dragon's Den Sandpit, Birmingham - Clinical Leadership & Mentoring 
Organisation University of Birmingham
Country United Kingdom 
Sector Academic/University 
PI Contribution Organisation of Dragon's Den Sandpit Event in Opthalmology
Collaborator Contribution Clinical leadership provided by Prof Robert Scott and Saaeha Rauz. Mentoring provided by Prof Liam Grover, Prof Ann Logan and Dr Graham Wallace.
Impact One project funded by EPSRC Centre - Electrospin & Electrostim. Additional projects being worked up.
Start Year 2014
 
Description Engagement Activity - Dragon's Den Sandpit, Birmingham - organisation 
Organisation University of Birmingham
Country United Kingdom 
Sector Academic/University 
PI Contribution Organisation and facilitation of the sandpit event, with funding provided for one project by the EPSRC Centre.
Collaborator Contribution Provision of venue free of charge.
Impact One project funded by EPSRC Centre - Electrospin & Electrostim. Additional projects being worked up.
Start Year 2014
 
Description Engagement Activity - Dragons Den Sandpit Event Bath 
Organisation University of Bath
Country United Kingdom 
Sector Academic/University 
PI Contribution Organisation of the event, payment for accommodation and catering.
Collaborator Contribution Free of charge provision of a meeting room, some local administrative organisation.
Impact Numerous projects created at the event and one project funded with £40,000 (80% fEC value).
Start Year 2012
 
Description Engagement Activity - Dragons Den Sandpit Event London 
Organisation University College London
Country United Kingdom 
Sector Academic/University 
PI Contribution Organisation of the event, payment for accommodation and catering.
Collaborator Contribution Free of charge provision of a meeting room, some local administrative organisation.
Impact Numerous projects created at the event and one project funded with £40,000 (80% fEC value).
Start Year 2014
 
Description Engagement Activity - Dragons Den Sandpit Event, Birmingham - Mentoring SA 
Organisation University of Liverpool
Country United Kingdom 
Sector Academic/University 
PI Contribution Organisation of Dragon's Den Sandpit in Opthalmology
Collaborator Contribution Mentoring provided by Dr Sajjad Ahmad
Impact One project funded by EPSRC Centre - Electrospin & Electrostim. Additional projects being worked up.
Start Year 2014
 
Description Engagement Activity - Dragons' Den Sandpit Event Newcastle 
Organisation Newcastle University
Country United Kingdom 
Sector Academic/University 
PI Contribution Organisation of the event, payment for accommodation and catering.
Collaborator Contribution Free of charge provision of a meeting room, some local administrative organisation.
Impact Numerous projects created at the event and one project funded with £40,000 (80% fEC value).
Start Year 2013
 
Description Engagement Activity - Harvard Stem Cell Institute Internship Programme 
Organisation Harvard University
Department Harvard Stem Cell Institute
Country United States 
Sector Academic/University 
PI Contribution Organised a nationwide competition for UK undergraduate students to apply for a place at the Harvard Stem Cell Institute summer internship program. Housing and travel costs covered by the EPSRC Centre.
Collaborator Contribution Considerable training of the winner, Elizabeth Cheeseman of Loughborough University, in stem cell techniques, and provision of a development opportunity for her.
Impact Internship competition winner Elizabeth Cheeseman is planning to apply for a PhD for 2015 entry. Ongoing relationship with Harvard, with joint StemBook activities.
Start Year 2014
 
Description Engagement Activity - Regen Med Careers Awareness Event CV Clinic Mentors 
Organisation GlaxoSmithKline (GSK)
Country Global 
Sector Private 
PI Contribution Organisation and publicity of the event, 66% subsidy on cost of attendance for early career researchers, payment of speakers' travel costs.
Collaborator Contribution CV clinic mentor (1 day plus prep time).
Impact Increase in awareness within early career community of alternative careers in the regenerative medicine sector. Increased confidence of early career researchers in applying for roles outside of the 'normal' route to postdoc/fellowship.
Start Year 2014
 
Description Engagement Activity - Regen Med Careers Awareness Event CV Clinic Mentors 
Organisation Intercytex
Country United Kingdom 
Sector Private 
PI Contribution Organisation and publicity of the event, 66% subsidy on cost of attendance for early career researchers, payment of speakers' travel costs.
Collaborator Contribution CV clinic mentor (1 day plus prep time).
Impact Increase in awareness within early career community of alternative careers in the regenerative medicine sector. Increased confidence of early career researchers in applying for roles outside of the 'normal' route to postdoc/fellowship.
Start Year 2014
 
Description Engagement Activity - Regen Med Careers Awareness Event CV Clinic Mentors 
Organisation Lonza Group
Country Global 
Sector Private 
PI Contribution Organisation and publicity of the event, 66% subsidy on cost of attendance for early career researchers, payment of speakers' travel costs.
Collaborator Contribution CV clinic mentor (1 day plus prep time).
Impact Increase in awareness within early career community of alternative careers in the regenerative medicine sector. Increased confidence of early career researchers in applying for roles outside of the 'normal' route to postdoc/fellowship.
Start Year 2014
 
Description Engagement Activity - Regen Med Careers Awareness Event CV Clinic Mentors 
Organisation Terumo BCT
Country United States 
Sector Private 
PI Contribution Organisation and publicity of the event, 66% subsidy on cost of attendance for early career researchers, payment of speakers' travel costs.
Collaborator Contribution CV clinic mentor (1 day plus prep time).
Impact Increase in awareness within early career community of alternative careers in the regenerative medicine sector. Increased confidence of early career researchers in applying for roles outside of the 'normal' route to postdoc/fellowship.
Start Year 2014
 
Description Engagement Activity - Regen Med Careers Awareness Event CV Clinic Mentors 
Organisation University of Leeds
Department Medical Technologies IKC
Country United Kingdom 
Sector Academic/University 
PI Contribution Organisation and publicity of the event, 66% subsidy on cost of attendance for early career researchers, payment of speakers' travel costs.
Collaborator Contribution CV clinic mentor (1 day plus prep time).
Impact Increase in awareness within early career community of alternative careers in the regenerative medicine sector. Increased confidence of early career researchers in applying for roles outside of the 'normal' route to postdoc/fellowship.
Start Year 2014
 
Description Engagement Activity - Regen Med Careers Awareness Event Regener8 
Organisation University of Leeds
Department Regener8
Country United Kingdom 
Sector Private 
PI Contribution Organisation and publicity of the event, 66% subsidy on cost of attendance for early career researchers, payment of speakers' travel costs.
Collaborator Contribution Co-organiser, marketing and speaker contribution.
Impact Increase in awareness within early career community of alternative careers in the regenerative medicine sector. Increased confidence of early career researchers in applying for roles outside of the 'normal' route to postdoc/fellowship.
Start Year 2014
 
Description Engagement Activity - Regen Med Careers Awareness Event SRG 
Organisation SRG
Country United Kingdom 
Sector Private 
PI Contribution Organisation and publicity of the event, 66% subsidy on cost of attendance for early career researchers, payment of speakers' travel costs.
Collaborator Contribution Training session provider (1 day plus prep time).
Impact Increase in awareness within early career community of alternative careers in the regenerative medicine sector. Increased confidence of early career researchers in applying for roles outside of the 'normal' route to postdoc/fellowship.
Start Year 2014
 
Description Engagement Activity - Regen Med Careers Awareness Event Speakers 
Organisation Cell Therapy Catapult
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution Organisation and publicity of the event, 66% subsidy on cost of attendance for early career researchers, payment of speakers' travel costs.
Collaborator Contribution Speaker role and CV clinic mentor (1 day plus prep time). [Cell Therapy Catapult provided 2 CV clinic mentors]
Impact Increase in awareness within early career community of alternative careers in the regenerative medicine sector. Increased confidence of early career researchers in applying for roles outside of the 'normal' route to postdoc/fellowship.
Start Year 2014
 
Description Engagement Activity - Regen Med Careers Awareness Event Speakers 
Organisation JRI Orthapaedics
Country United Kingdom 
Sector Private 
PI Contribution Organisation and publicity of the event, 66% subsidy on cost of attendance for early career researchers, payment of speakers' travel costs.
Collaborator Contribution Speaker role and CV clinic mentor (1 day plus prep time). [Cell Therapy Catapult provided 2 CV clinic mentors]
Impact Increase in awareness within early career community of alternative careers in the regenerative medicine sector. Increased confidence of early career researchers in applying for roles outside of the 'normal' route to postdoc/fellowship.
Start Year 2014
 
Description Engagement Activity - Regen Med Careers Awareness Event Speakers 
Organisation NHS National Services Scotland (NSS)
Department Scottish National Blood Transfusion Service
Country United Kingdom 
Sector Public 
PI Contribution Organisation and publicity of the event, 66% subsidy on cost of attendance for early career researchers, payment of speakers' travel costs.
Collaborator Contribution Speaker role and CV clinic mentor (1 day plus prep time). [Cell Therapy Catapult provided 2 CV clinic mentors]
Impact Increase in awareness within early career community of alternative careers in the regenerative medicine sector. Increased confidence of early career researchers in applying for roles outside of the 'normal' route to postdoc/fellowship.
Start Year 2014
 
Description Engagement Activity - Regen Med Careers Awareness Event Speakers 
Organisation Puridify
Country United Kingdom 
Sector Private 
PI Contribution Organisation and publicity of the event, 66% subsidy on cost of attendance for early career researchers, payment of speakers' travel costs.
Collaborator Contribution Speaker role and CV clinic mentor (1 day plus prep time). [Cell Therapy Catapult provided 2 CV clinic mentors]
Impact Increase in awareness within early career community of alternative careers in the regenerative medicine sector. Increased confidence of early career researchers in applying for roles outside of the 'normal' route to postdoc/fellowship.
Start Year 2014
 
Description Engagement Activity - Regen Med Careers Awareness Event Speakers 
Organisation Smith and Nephew
Country United Kingdom 
Sector Private 
PI Contribution Organisation and publicity of the event, 66% subsidy on cost of attendance for early career researchers, payment of speakers' travel costs.
Collaborator Contribution Speaker role and CV clinic mentor (1 day plus prep time). [Cell Therapy Catapult provided 2 CV clinic mentors]
Impact Increase in awareness within early career community of alternative careers in the regenerative medicine sector. Increased confidence of early career researchers in applying for roles outside of the 'normal' route to postdoc/fellowship.
Start Year 2014
 
Description Engagement Activity - Regen Med Careers Awareness Event Speakers 
Organisation University of Leicester
Country United Kingdom 
Sector Academic/University 
PI Contribution Organisation and publicity of the event, 66% subsidy on cost of attendance for early career researchers, payment of speakers' travel costs.
Collaborator Contribution Speaker role and CV clinic mentor (1 day plus prep time). [Cell Therapy Catapult provided 2 CV clinic mentors]
Impact Increase in awareness within early career community of alternative careers in the regenerative medicine sector. Increased confidence of early career researchers in applying for roles outside of the 'normal' route to postdoc/fellowship.
Start Year 2014
 
Description Engagement Activity - Right Product, Right Patient, Right Time KTN 
Organisation Knowledge Transfer Network
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution Provided funding and local venue booking support for hosting the 'Right product, right patient, right time' meeting with the KTN at Loughborough University. Provided input to the design of the agenda, promoted the event and attracted the EPSRC's academic and industrial partners.
Collaborator Contribution Organisational support for the event - registration, logistics on the day. Led on design of the agenda. Considerable input into promotion among the KTN's network.
Impact StemBook publication resulted from the variety of talks during the event - http://www.stembook.org/node/6149
Start Year 2013
 
Description Engagement Activity - Right Product, Right Patient, Right Time Speakers 
Organisation Asymptote
Country United Kingdom 
Sector Private 
PI Contribution Co-organised the event 'Getting the product to the patient - right time, right place and safe to deliver: Challenges and innovation in cold chain, supply logistics and transport' with the Knowledge Transfer Network.
Collaborator Contribution Attendance at the event and speaker slot.
Impact Transfer of best practice from various sectors to facilitate step-change improvements in the regenerative medicine supply chain. Resulted in publication of StemBook paper 'From production to patient: challenges and approaches for delivering cell therapies' by Nick Medcalf and Karen Coopman.
Start Year 2013
 
Description Engagement Activity - Right Product, Right Patient, Right Time Speakers 
Organisation Cell Therapy Catapult
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution Co-organised the event 'Getting the product to the patient - right time, right place and safe to deliver: Challenges and innovation in cold chain, supply logistics and transport' with the Knowledge Transfer Network.
Collaborator Contribution Attendance at the event and speaker slot.
Impact Transfer of best practice from various sectors to facilitate step-change improvements in the regenerative medicine supply chain. Resulted in publication of StemBook paper 'From production to patient: challenges and approaches for delivering cell therapies' by Nick Medcalf and Karen Coopman.
Start Year 2013
 
Description Engagement Activity - Right Product, Right Patient, Right Time Speakers 
Organisation Grimsby Institute of Further and Higher Education
Country United Kingdom 
Sector Academic/University 
PI Contribution Co-organised the event 'Getting the product to the patient - right time, right place and safe to deliver: Challenges and innovation in cold chain, supply logistics and transport' with the Knowledge Transfer Network.
Collaborator Contribution Attendance at the event and speaker slot.
Impact Transfer of best practice from various sectors to facilitate step-change improvements in the regenerative medicine supply chain. Resulted in publication of StemBook paper 'From production to patient: challenges and approaches for delivering cell therapies' by Nick Medcalf and Karen Coopman.
Start Year 2013
 
Description Engagement Activity - Right Product, Right Patient, Right Time Speakers 
Organisation Intercytex
Country United Kingdom 
Sector Private 
PI Contribution Co-organised the event 'Getting the product to the patient - right time, right place and safe to deliver: Challenges and innovation in cold chain, supply logistics and transport' with the Knowledge Transfer Network.
Collaborator Contribution Attendance at the event and speaker slot.
Impact Transfer of best practice from various sectors to facilitate step-change improvements in the regenerative medicine supply chain. Resulted in publication of StemBook paper 'From production to patient: challenges and approaches for delivering cell therapies' by Nick Medcalf and Karen Coopman.
Start Year 2013
 
Description Engagement Activity - Right Product, Right Patient, Right Time Speakers 
Organisation World Courier
Country United States 
Sector Private 
PI Contribution Co-organised the event 'Getting the product to the patient - right time, right place and safe to deliver: Challenges and innovation in cold chain, supply logistics and transport' with the Knowledge Transfer Network.
Collaborator Contribution Attendance at the event and speaker slot.
Impact Transfer of best practice from various sectors to facilitate step-change improvements in the regenerative medicine supply chain. Resulted in publication of StemBook paper 'From production to patient: challenges and approaches for delivering cell therapies' by Nick Medcalf and Karen Coopman.
Start Year 2013
 
Description Engagement Activity - StemBook 
Organisation Harvard University
Department Harvard Stem Cell Institute
Country United States 
Sector Academic/University 
PI Contribution Provided guidance on potential manufacturing content for StemBook, an online peer-reviewed repository aimed at stem cell experts and non-experts. David Williams joined the editorial board. EPSRC Centre members co-authored numerous papers within the new manufacturing chapter created.
Collaborator Contribution Editorial support for new manufacturing chapter - arranging peer-review of papers and maintenance of online repository.
Impact New manufacturing chapter for StemBook, providing material for knowledge exchange and training. Numerous papers include EPSRC Centre authors.
Start Year 2014
 
Description Engagement Activity - Summer Student British Mass Spectrometry Society 
Organisation British Mass Spectrometry Society
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution Design and supervision of the project, training the next generation of doctors.
Collaborator Contribution Sponsorship of student bursary for summer project.
Impact Work presented at Mercia Stem Cell Alliance meeting. Training the next generation of doctors.
Start Year 2014
 
Description Engagement Activity - Summer Student PA Consulting 
Organisation PA Consulting
Country United Kingdom 
Sector Private 
PI Contribution PA Consulting were introduced to Keele University academics through the Head of Engagement, followed by negotiation of the summer project content and how it would be funded.
Collaborator Contribution PA Consulting funded the student bursary and co-supervised the project. Provided training experience for a future medical doctor.
Impact Progress in the design of a medical device for improving the delivery and effect of stem cell treatments to the knee.
Start Year 2014
 
Description Engagement Activity - Summer Student Waters Corporation 
Organisation Waters Corporation
Department Waters Corporation Centre of Mass Spectrometry Excellence
Country United Kingdom 
Sector Private 
PI Contribution Project design, supervision of the student, engagement of company.
Collaborator Contribution Project design with Keele academics, co-supervision of medical student for the summer.
Impact Work presented at a Mercia Stem Cell Alliance meeting. Training of the next generation of doctors.
Start Year 2014
 
Description Engagement Activity - Summer Students x2 nanoTherics 
Organisation nanoTherics Ltd
Country United Kingdom 
Sector Private 
PI Contribution nanoTherics introduced to two projects based at Keele for the summer of 2014. Can magnetic hyperthermia safely enhance magnetic nanoparticle labelling of neural stem cells? and Using a novel multifunctional magnetic nanoparticle with a state-of-the-art 'magnetofection' device to enhance gene transfer to neural transplant cells?
Collaborator Contribution nanoTherics provided support in designing the two projects and provided the medical students with experience of working with an industrial company.
Impact Presentation at INSPIRE student conference. Training of future doctors in research and development and ways of working with industry.
Start Year 2014
 
Description Engagement Activity - UK Science and Innovation Network 
Organisation Department for Business, Energy & Industrial Strategy
Department UK Science and Innovation Network
Country United Kingdom 
Sector Public 
PI Contribution Interaction with UK Science and Innovation Network on a regular basis, resulting in a mission to Boston, development of a new manufacturing chapter for StemBook in collaboration with the Harvard Stem Cell Institute and a UK-wide competition to send an undergraduate student to undertake Harvard's prestigious summer internship programme.
Collaborator Contribution Introductions to key colleagues in Boston and the surrounding area. Organisation of the Boston mission.
Impact New manufacturing chapter in StemBook. Publication by EPSRC Centre authors of numerous papers within this chapter. UK-wide national competition resulting in Elizabeth Cheeseman attending Harvard's prestigious internship programme.
Start Year 2012
 
Description Hypoxia cell culture equipment 
Organisation Ruskinn Technology Ltd
Country United Kingdom 
Sector Private 
PI Contribution Keele developed a system for rapid deoxygenation of cell culture media for application in cell therapy manufacturing. This technology was filed for patent in both US and EU systems. The US patent was allowed to drop and the EU patent is still pending.
Collaborator Contribution Baker Ruskinn licensed the technology from Keele and provided the engineering expertise to develop prototype systems to valid the system for cell therapy manufacturing purposes.
Impact A wide range of publications and conference presentations have resulted from this collaborative research. This was a multidisciplinary project requiring cell therapy and stem cell biology expertise coupled to engineering expertise.
Start Year 2009
 
Description Near patient cell processing 
Organisation Athersys Inc.
Country United States 
Sector Private 
PI Contribution Our cell therapy facility was utilized for closed cell processing of the Athersys Multistem cell therapy product for application in an ischemic stroke focused clinical trial.
Collaborator Contribution Athersys provided financial support for cell processing and were running the clinical trial.
Impact N/A
Start Year 2014
 
Title COMPOSITION AND DELIVERY SYSTEM 
Description An injectable agent delivery system comprising a composition that comprises: an agent for sustained delivery located within discrete particles; and an injectable scaffold material comprising discrete particles which are capable of interacting to form a scaffold, and uses thereof. 
IP Reference WO2015019109 
Protection Patent application published
Year Protection Granted 2015
Licensed Yes
Impact The patent forms the basis of activity for Locate Therapeutics. The technology is a platform from which formulated derivatives can be made.
 
Title Methods and apparatuses relating to cell culture media 
Description A method and apparatus to deoxygenate cell culture media to defined set-points. 
IP Reference 08775852.0 
Protection Patent application published
Year Protection Granted 2010
Licensed Yes
Impact N/A
 
Title Methods and apparatuses relating to cell culture media 
Description A method and apparatus to deoxygenate cell culture media to defined set-points. 
IP Reference  
Protection Protection not required
Year Protection Granted 2013
Licensed Yes
Impact The intellectual property has formed the basis of a commercial instrument manufacturing and sales campaign by Baker Ruskinn. This brings an income stream to Keele under a fixed royalty arrangement. Further technological developments are being made as line extensions and as separate innovations. These items are, however, still confidential. Sales are satisfactory for a device of this size and sophistication.
 
Title Polymer Particles Prepared From Polymerisable Alkylene Glycol (Meth) Acrylate Monomers 
Description The invention provides polymer particles that are obtainable by a method selected from emulsion methods, diffusion methods and evaporation methods carried out in the presence of surface-engineering surfactant which is one or more polymer that displays a lower critical solution temperature, in aqueous media, that is between 10 to 90° C., this polymer being the polymerisation product of one or more monomer selected from polymerisable alkyleneglycol acrylate monomers and polymerisable alkyleneglycol methacrylate monomers. The polymer particles can be used in controlled release applications, such as flavour release applications, fragrance release applications and biomedical applications. The invention also provides a cell support matrix comprising the polymer particles. 
IP Reference US2011305767 
Protection Patent application published
Year Protection Granted 2011
Licensed Commercial In Confidence
Impact The invention is used for controlling cell behaviour in regenerative medicine applications. The thermally-switchable behaviour opens up options for managing cell deposition for a variety of uses in advanced therapeutics.
 
Title Responsive Magnetic Particulate Dispersion for Ex-vivo Cellular Expansion on 2D and 3D Cell Culture and Cell Recovery via Magnetic Separation 
Description Scaffold production for regenerative medicine. 
IP Reference GB1212595.1 
Protection Patent granted
Year Protection Granted 2012
Licensed Yes
Impact IP for this technology was licensed to Locate Therapeutics Ltd. The company has secured a 2 year Wellcome Trust award to develop for scale up of cell manufacturing.
 
Title STEM CELL CULTURE METHOD 
Description Methods for culturing pluripotent stem cells on fiber scaffolds are provided which result in the expansion of the number of stem cells without loss of pluripotency. Cells obtained by such methods, implants containing such cells and medical methods using such cells are also disclosed. 
IP Reference US2014050704 
Protection Patent granted
Year Protection Granted 2014
Licensed No
Impact The technology provides a culture environment that can be used by researchers to enable biomimetic 3D culture of pluripotent cells.
 
Title Hydrostatic bioreactor for tissue engineering regenerative medicine 
Description During the project we designed a Hydrostatic bioreactor with the company TGT in the USA. This company was then bought by Bose Enduratec. The product has been sold worldwide. 
Type Support Tool - For Medical Intervention
Current Stage Of Development Wide-scale adoption
Year Development Stage Completed 2017
Development Status Under active development/distribution
Impact The new design has led on to further work and further EPSRC funding. The design is now being replicated in product ranges form other companies 
 
Company Name Shunxi Stem Cell Engineering Ltd 
Description Shunxi Stem cell engineering ltd was established in the Institute of Life Science, Swansea University, to develop low-cost bench-top bioreactors. The start-up received KESS grant from Wales government, is for industry-academic collaboration to fund one master student working on automated bioreactor and microcarriers for therapeutical cell manufacturing. The work in Swansea is mainly to test the bioreactor with different cell types and microcarriers. Dr Hao Zhang, a PDRA from the CIM, is leading a team of 8 engineers to develop the bioreactor from scratch, with own medium supply and mixing, air supply, and temperature control hardware and software in China. 
Year Established 2014 
Impact The company has not been in business long enough to have a significant impact in the UK.
Website https://beta.companieshouse.gov.uk/company/08978787/officers
 
Description Bioprinting talk to NC3Rs workshop 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Industry/Business
Results and Impact The NC3Rs, Innovate UK and the Knowledge Transfer Network jointly hosted a workshop to advance the development and application of bioprinting approaches for improved efficacy and safety testing of drugs and other chemicals. A significant number of industrialists were present and the clinical translation and regulatory emphasis of the presentation given were of particular interest to the audience and led to some new planned interactions with industry partners.
Year(s) Of Engagement Activity 2015
URL https://www.nc3rs.org.uk/events/bioprinting-for-more-predictive-efficacy-and-safety-testing
 
Description Cell and Gene Therapy: 21st Century Medicines 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Schools
Results and Impact The engagement event was held in collaboration with Cobra Biologics and was designed to introduce basic knowledge and career options in the arena of Cell and Gene Therapy. We welcomed around 100 GCSE and A-level students from both local and national backgrounds to hear a range of presentations including from the Cell and Gene Therapy Catapult, Cobra Biologics, and ISTMs Prof James Richardson, himself a pioneer of cell therapy in the UK. A lively discussion was held immediately following on from the talks (~15 minutes) after which snacks and drinks were provided around a number of trade stalls where further discussion was held. Widespread positive feedback was received following on from the event including requests for next years dates.
Year(s) Of Engagement Activity 2017
URL http://www.cobrabio.com/News/December-2017/Post-Event-21Cmed
 
Description ECP007 Bioreactor Course 2013 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? Yes
Geographic Reach Regional
Primary Audience Postgraduate students
Results and Impact Representation of our industrial partner, Instron, at the bioreactor course and demonstration of their hydrostatic bioreactor system.

Spoke to postgraduate students, colleagues and industry representatives.
Year(s) Of Engagement Activity 2013
URL http://www.keele.ac.uk/bioreactorcourse/courseoverview/
 
Description ECP007 Bioreactor Course 2014 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? Yes
Geographic Reach Local
Primary Audience Postgraduate students
Results and Impact Oral presentation at the bioreactor course.

Spoke to postgraduate students, academics and representatives from industry.
Year(s) Of Engagement Activity 2014
URL http://www.keele.ac.uk/bioreactorcourse/home/
 
Description ECP050 TSB 1 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact 1st Tools and Services for Synthetic Biology TSB Workshop, Manchester, UK
60 Industrial Enterprise and Academic representatives attended a TSB workshop in Synthetic Biology, I presented key work of the EPSRC Centre which sparked questions and discussion afterwards.

Met two new collaborators with whom I had follow up meetings and discussions regarding collaborative research; 1 developed into a successful fellowship bid.
Year(s) Of Engagement Activity 2013
 
Description ECP050 TSB 2 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact 2nd Tools and Services for Synthetic Biology TSB Workshop, Cardiff, UK
60 Industrial enterprise and academic research representatives attended a TSB workshop in Synthetic Biology, I presented key work of the EPSRC Centre and the automation and scaling work performed at Loughborough University.

TSB Lead Technologist in Synthetic Biology requested a visit to my host department, the Centre for Biological Engineering at Loughborough University and to meet the EPSRC Centre team based at Loughborough.
Year(s) Of Engagement Activity 2013
 
Description Education needs interview (The Telegraph) 
Form Of Engagement Activity A press release, press conference or response to a media enquiry/interview
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Media (as a channel to the public)
Results and Impact N Medcalf was interviewed by Helena Pozniak, a journalist at the Daily Telegraph for a feature on future job opportunities in medical technology as part of their "Careers of the Future" supplement. This is to show that it is technology as a growth area and explain why it offers significant opportunities for young people, as well as potential paths into a career in the field.

The release will come out on the 18th March, hence "Not aware of any impact" below.
Year(s) Of Engagement Activity 2016
 
Description Engagement Activity - ARMA Training 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? Yes
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Head of Engagement invited to give training session on using social media to engage partners which was delivered as part of a collaboration-building training session for research managers and administrators. Average scores of 4.4 out of 5 for format and delivery and 4.2 out of 5 for content and materials.

Audience reported increase in knowledge of social media, and in particular how it can be applied to engaging partners.
Year(s) Of Engagement Activity 2014
 
Description Engagement Activity - Annual Summit 
Form Of Engagement Activity Participation in an open day or visit at my research institution
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Annual regenerative medicine manufacturing summit held, bringing together EPSRC Centre members with key collaborators from the clinical, commercial and regulatory areas.

Constructive discussions regarding the focus of EPSRC Centre research projects and initiatives - especially regulatory science, engagement, training and careers awareness.
Year(s) Of Engagement Activity 2012,2013,2014
 
Description Engagement Activity - Big Bang Fair 2014 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? Yes
Geographic Reach National
Primary Audience Schools
Results and Impact Represented the EPSRC, at their invitation, on their stand at an event with a footfall of approx. 75,000. Approx. 5,000 school age learners estimated to have visited our stand. Research communicated included cell biology, scaffold creation and scale-up of cell culture.

Follow-up from teachers for future schools visits. Request from Rutherford Appleton Laboratory for a speaker for their schools engagement programme, Karen Coopman will be presenting in 2015. Increase in visitors to our blog www.heartblog.net which was promoted at the event.
Year(s) Of Engagement Activity 2014
URL http://www.thebigbangfair.co.uk/
 
Description Engagement Activity - Big Bang Fair London 2014 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? Yes
Geographic Reach Regional
Primary Audience Schools
Results and Impact Approx. 500 school age learners estimated to have visited our stand. Research communicated included cell biology, scaffold creation and scale-up of cell culture.

Follow-up from charity specialising in supporting learners from economically deprived areas. Increase in visitors to our blog www.heartblog.net which was promoted at the event.
Year(s) Of Engagement Activity 2014
URL http://www.thebigbangfair.co.uk/
 
Description Engagement Activity - Biomat-IN consortium 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? Yes
Geographic Reach International
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Invited to present at Biomat-IN consortium, to investigate possibility of UK regenerative medicine manufacturing academics working with the existing consortium to source additional funding to extend the work of the consortium. Sophie Dale-Black presented on the regenerative medicine manufacturing expertise across the UK and invited consortium members to contact her for introductions to UK academics.

Introduction to fifteen Europe-wide academic and commercial organisations. Follow-up with visit to Loughborough University by consortium members. Follow-up with academic partners ongoing regarding possible Horizon 2020 European funding bids.
Year(s) Of Engagement Activity 2014
URL http://www.epsrc-regen-med.org/outreach/promoting-the-uk-community/
 
Description Engagement Activity - Biomat-IN visit 
Form Of Engagement Activity Participation in an open day or visit at my research institution
Part Of Official Scheme? Yes
Geographic Reach International
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Visit to Loughborough University by members of the Biomat-IN consortium - laboratory tour plus meeting time with academics.

Follow-up discussions regarding ways of working together for EU funding calls.
Year(s) Of Engagement Activity 2014
URL http://www.epsrc-regen-med.org/outreach/promoting-the-uk-community/
 
Description Engagement Activity - Bose Video 
Form Of Engagement Activity A press release, press conference or response to a media enquiry/interview
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact David Williams and Yang Liu interviewed for a Bose ElectroForce video regarding the EPSRC Centre's 'Hydrogels for treatment of intervertebral disc degeneration' project.

Publicity of the 'Hydrogels for treatment of intervertebral disc degeneration' project and demonstration of engagement with Bose ElectroForce as a commercial partner.
Year(s) Of Engagement Activity 2014
URL http://www.epsrc-regen-med.org/news/epsrc-centre-and-dtc-members-appear-in-new-bose-electroforce-vid...
 
Description Engagement Activity - Boston Mission 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? Yes
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact The EPSRC Centre undertook a mission to Boston, USA, in collaboration with the UK Science and Innovation Network at the British Consulate-General, to explore the biomanufacturing activities ongoing in Massachusetts and to develop new relationships for cooperation in cell therapy and regenerative medicine. The mission delegates had the opportunity to meet with many Boston organisations, including the MIT BioMAN Research Program site, the Harvard Stem Cell Institute, the Massachusetts Life Sciences Center and companies Xcellerex and Joule Unlimited.

The mission allowed the promotion of the UK community's capabilities to a highly relevant US audience, sowing the initial seeds for future international collaborations.
Year(s) Of Engagement Activity 2013
URL http://www.epsrc-regen-med.org/outreach/promoting-the-uk-community/
 
Description Engagement Activity - Dragons Den Sandpit Event - Birmingham 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Dragons' Den sandpit event, themed on Opthalmology, attended by 26 participants and 9 mentors/clinical leads/facilitators.

One project funded with £50K of EPSRC Centre funding 'Electrospin & Electrostim'. Four other projects deemed fundable by the panel, teams being encouraged to follow-up discussions and submit bids to external funding agencies.
Year(s) Of Engagement Activity 2014
 
Description Engagement Activity - EATRIS 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? Yes
Geographic Reach International
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Engagement of the EATRIS translational medicine infrastructure, which does not have UK members at present. Attendance of the 2013 ATMP platform meeting - presentation by Sophie Dale-Black on UK-wide regenerative medicine manufacturing activities and expertise. Attendance of the 2014 ATMP platform meeting - presentation by Mark McCall on cost of goods sold and its relationship to regenerative medicine manufacturing.

Visit by EATRIS senior management to EPSRC Centre. Follow-on activities under discussion - e.g. potential white paper, talks at European conferences etc. Visit to EPSRC Centre by Giuseppe Banfi of Galeazzi Institute, Milan, to discuss possible EU bids. Introduction of Giuseppe Banfi to Cell Therapy Catapult.
Year(s) Of Engagement Activity 2013,2014
URL http://www.epsrc-regen-med.org/outreach/promoting-the-uk-community/
 
Description Engagement Activity - Galeazzi Institute 
Form Of Engagement Activity Participation in an open day or visit at my research institution
Part Of Official Scheme? Yes
Geographic Reach International
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Visit by Giuseppe Banfi to EPSRC Centre, to meet with Loughborough, Nottingham and Keele university representatives.

Discussion of possible collaborative EU funding bids. Reciprocal introductions of EPSRC Centre academics to members of Galeazzi Institute.
Year(s) Of Engagement Activity 2014
URL http://www.epsrc-regen-med.org/outreach/promoting-the-uk-community/
 
Description Engagement Activity - HEART Blog 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact HEART blog (www.heartblog.net) is a collection of posts from 40+ students, researchers and academics who wish to communicate their research in the areas of Healthcare Engineering and Regenerative Therapies to the public, specifically to young learners of ages 11-19. The blog underpins the schools and public engagement work that is carried out by members of the EPSRC Centre for Innovative Manufacturing in Regenerative Medicine and the EPSRC-MRC Centre for Doctoral Training in Regenerative Medicine, with guest posts from the EPSRC Centre for Doctoral Training in Targeted Therapeutics and Formulation Sciences. The HEART blog features two posts a week, at 11am UK time on a Tuesday and a Thursday. During school holidays, this is reduced to one post a week. The blog is created through Tumblr and is cross-posted to the Twitter (@HEARTregenmed) and Facebook (www.facebook.com/heartblog) social media platforms.

The blog has had a total of 2,400 page views to date (Oct 27th 2014), with a returning visitor percentage of 40%. The blog also has an 'ask an expert' function where learners can ask questions of the scientists and engineers, allowing engagement with blog readers. The blog is used to follow-up after visits by researchers to schools to directly engage young learners.
Year(s) Of Engagement Activity 2014
URL http://www.heartblog.net
 
Description Engagement Activity - HEART Outreach Brand 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Schools
Results and Impact The HEART (Healthcare Engineering and Regenerative Therapies) brand has been created jointly by the EPSRC Centre for Innovative Manufacturing in Regenerative Medicine and the EPSRC-MRC Centre for Doctoral Training in Regenerative Medicine. HEART is an umbrella brand covering all public and schools engagement work in the two centres, from social media (Twitter, Tumblr, Facebook, www.heartblog.net blog) to exhibitions (e.g. Big Bang Fair).

HEART team members featured on BBC Breakfast News during the Big Bang Fair 2014 exhibition. Communication skills have been improved among HEART team members through receiving advanced outreach skills training and gaining experience in communicating their science through blog posts. Over 7,000 learners have been engaged through exhibitions and school workshops.
Year(s) Of Engagement Activity 2014
URL http://www.heartblog.net
 
Description Engagement Activity - NOMs meeting 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Organised one-day meeting for National Outreach Managers from EPSRC Centres. Delivered two talks - one on outreach/engagement in regenerative medicine manufacturing and one on using social media tools to perform outreach/engagement.

A number of National Outreach Managers adapted their social media strategies to include elements from our EPSRC Centre.
Year(s) Of Engagement Activity 2014
 
Description Engagement Activity - Nanomedicine European Technology Platform 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? Yes
Geographic Reach International
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact The EPSRC Centre joined the Nanomedicine European Technology Platform to represent UK academics in regenerative medicine manufacturing. Attended the 2014 annual general meeting.

Contributed to the ETP's map of collaborators to ensure good UK inclusion. Joined working groups in regenerative medicine and training/education. Contributed to strategic research and innovation agenda of the ETP through both working groups.
Year(s) Of Engagement Activity 2013,2014
URL http://www.epsrc-regen-med.org/outreach/promoting-the-uk-community/
 
Description Engagement Activity - REMEDIC Consortium 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? Yes
Geographic Reach International
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Attended workshop organised by the REMEDIC Consortium, to investigate the possibility of UK academics working with the existing consortium to source additional funding to extend the work of the consortium. The consortium did not contain any UK partners. Sophie Dale-Black presented on the regenerative medicine manufacturing expertise across the UK and invited consortium members to contact her for introductions to UK academics.

Introduction to ten Europe-wide academic and commercial organisations. Follow-up with academic partners ongoing regarding possible Horizon 2020 European funding bids.
Year(s) Of Engagement Activity 2013
URL http://www.epsrc-regen-med.org/outreach/promoting-the-uk-community/
 
Description Engagement Activity - Regen Med Careers Awareness Event 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Over 55 students and postdocs from 12 institutions across the UK attended the UK's first careers awareness event in regenerative medicine, which we facilitated in conjunction with Regener8. Speakers and CV clinic mentors arranged from GSK, Lonza, SRG, TerumoBCT, Smith & Nephew, Puridify, Regner8, the Medical Technologies IKC, the University of Leicester, Loughborough University, the Cell Therapy Catapult, Intercytex, JRI Orthopaedics, SRG and the Scottish National Blood Transfusion Service. Review of the event published on EPSRC Centre website and opinion piece published in Orthopaedic Product News.

Increased awareness by early career researchers of roles in the regenerative medicine industry. Should contribute to reduced leakage of skills from the sector. Should reduce oversubscription to fellowship calls as alternatives have been highlighted.
Year(s) Of Engagement Activity 2014
URL http://www.epsrc-regen-med.org/news/review-of-the-first-national-regenerative-medicine-careers-event...
 
Description Engagement Activity - Royal Society Summer Science Exhibition 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? Yes
Geographic Reach National
Primary Audience Schools
Results and Impact Team led by Kevin Shakesheff designed and delivered the Biology Builders exhibition during the week-long summer science exhibition.

Engagement of school age learners from across the UK. Engagement of VIPs during evening soiree, including scientific TV personalities.
Year(s) Of Engagement Activity 2013
URL http://www.epsrc-regen-med.org/biologybuilders/
 
Description Engagement Activity - Social Media 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Social media is used to promote and disseminate the EPSRC Centre's successes to academic, clinical and commercial contacts, and also to the public as a whole. Platforms used include Twitter (@RM_Outreach and @HEARTregenmed), LinkedIn (public feed plus group and company pages), Mailchimp (e-newsletters), Tumblr (HEART outreach).

Engagement of existing partners achieved in a smart way - short, directed messages and longer, aesthetically-designed e-newsletters. Engagement of new partners through public feeds on social media. Followers in excess of 1000 plus public feed immeasurable. Reach of messages enhanced through sharing/retweeting by EPSRC Centre members, the EPSRC itself and key partners such as the Cell Therapy Catapult.
Year(s) Of Engagement Activity 2013,2014
URL http://www.epsrc-regen-med.org/outreach/
 
Description Engagement Activity - TERM Consortium 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? Yes
Geographic Reach International
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Invited to present at TERM Consortium annual meeting in Nantes, France, to investigate possibility of UK academics working with the existing consortium to source additional funding to extend the work of the consortium. The consortium did not contain any UK partners. Sophie Dale-Black presented on the regenerative medicine manufacturing expertise across the UK and invited consortium members to contact her for introductions to UK academics.

Introduction to fifteen Europe-wide academic and commercial organisations. Visits to four companies and training sites in Nantes. Follow-up with academic partners ongoing regarding possible Horizon 2020 European funding bids.
Year(s) Of Engagement Activity 2013
URL http://www.epsrc-regen-med.org/outreach/promoting-the-uk-community/
 
Description Engagement Activity - Towards 2020 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact 'Regenerative Medicine Manufacturing: Towards 2020' was published in September 2014 as a proposition to existing and new collaborators regarding ways of working with the EPSRC Centre. The publication demonstrated successes from the EPSRC Centre but primarily focused on identifying ways of working with collaborators for the next five years.

Follow-up with commercial collaborators who received the publication, discussions ongoing regarding new collaborative projects.
Year(s) Of Engagement Activity 2014
URL http://www.epsrc-regen-med.org/news/regenerative-medicine-manufacturing-towards-2020/
 
Description Engagement Activity - UKTI proposition 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? Yes
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact Worked with UKTI to incorporate EPSRC Centre's work into the UKTI regenerative medicine proposition, and to contribute to the representation of the national picture on behalf of the UK national community.

Publication through UKTI website and in-print. Publicity worldwide through a drive for incoming investment into the UK.
Year(s) Of Engagement Activity 2014
URL http://ukti.bellman.co.uk/
 
Description Engagement Activity - UKTI visit to Loughborough University 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? Yes
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Visit to Loughborough University by 25 British Embassy and Consulate representatives as part of a UKTI tour of the life sciences work in the UK. Loughborough, Nottingham, Keele, Birmingham and Leeds universities were engaged with the regenerative medicine component of this visit.

Follow-ups with embassies worldwide for further information on regenerative medicine research.
Year(s) Of Engagement Activity 2014
 
Description European Medicines Agency consultation 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Policymakers/politicians
Results and Impact The Centre has been active within the European Regulatory area through an initiative with EATRIS. In 2015 a joint meeting was held with the European Medicines Agency at Canary Wharf with the objective of introducing the Centre/EATRIS initiative in distributed manufacturing. an invitation has been extended for Loughborough to put key research questions to the Committee for Advanced Therapeutics in 2016 which could result in cooperative effort to establish a collaborative program of work in EMA priority areas.
Year(s) Of Engagement Activity 2015
 
Description ISO TC276 workshop on 'manufacturability' 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Industry/Business
Results and Impact The Centre has a leading role in the regenerative medicine work of ISO Technical Committee 276 (Bioprocessing) working alongside BSi and LGC. In November 2015 a workshop was held at Loughborough at the request of the Japanese delegation and convener (Heki, Tatsuo of FIRM) to examine the topic of 'manufacturability' i.e. that property of well-designed cell processes that can provide out-scalable manufacture. Nick Medcalf is leading this activity which will result in a white Paper in 2016 co-produced by the Japanese, US, UK and South Korean delegates.
Year(s) Of Engagement Activity 2015
 
Description Industry Day 2016 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Industry/Business
Results and Impact The presentation of CIM output and capability has been made principally through the Industry Days. Usually annual, the most recent of these, a two-day event at Cambridge University (Madingley Hall) in January 2016 enabled researchers to showcase their work and to co-produce a series of research priorities with the delegates via workshops on day two. The output of the meeting has been briefed informally to the EPSRC and will form the basis of a White Paper after the current reporting round.
Year(s) Of Engagement Activity 2016
 
Description Navigating Regulatory Requirements for Redistributed Manufacturing in Healthcare (MRC, London) 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Industry/Business
Results and Impact This workshop in conjunction with the MHRA invited experts from a range of Universities and industrial companies to discuss and review future regulatory requirements for redistributed healthcare manufacturing.
Year(s) Of Engagement Activity 2016
 
Description Visit and seminar at Wyss Institute 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact I was invited to give a talk on "Manufacturing Process Developments for Bioprinting and Tissue Engineering". The audience of between 50 and 100 people consisted of Clinicians from the Massachusetts General Hospital and the Boston Childrens Hospital, research staff from Harvard, Wyss Institute research staff and a number of postgraduate researchers from Harvard.
The talk focused on two main areas of manufacturing process development to support bioprinting activities and the electrospinning of cell scaffolds and the application of design for manufacture principles to contribute to the clinical translation.
As a result, several discussions took place connected with bioprinting and electrospinning work funded by the EPSRC and potential collaborations are currently being explored.
Year(s) Of Engagement Activity 2015
URL http://wyss.harvard.edu/viewevent/478/manufacturing-process-developments-for-bioprinting-and-tissue-...