FUTURE TARGETED HEALTHCARE MANUFACTURING HUB

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

Abstract

By 2025 targeted biological medicines, personalised and stratified, will transform the precision of healthcare prescription, improve patient care and quality of life. Novel manufacturing solutions have to be created if this is to happen. This is the unique challenge we shall tackle. The current "one-size-fits-all" approach to drug development is being challenged by the growing ability to target therapies to only those patients most likely to respond well (stratified medicines), and to even create therapies for each individual (personalised medicines). Over the last ten years our understanding of the nature of disease has been transformed by revolutionary advances in genetics and molecular biology.

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

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

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

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

Planned Impact

WHO WILL BENEFIT FROM THE RESEARCH
The impact of the Future Targeted Healthcare Manufacturing Hub will extend far beyond the Hub itself with significant benefits for manufacturing companies, healthcare providers, UK citizens and the economy as a whole.

Companies
The stratified protein medicines and cellular therapies of the future cannot be made or developed using the manufacturing technologies in use for current therapies. A radical step-change and innovation to deliver the economically viable processes is required. UK companies will benefit from new process technologies designed to deliver these step changes with the necessary cost performance and speed of development. The companies will also benefit from new decision support tools that will provide a robust framework for selecting processes and manufacturing options reducing the risk of misallocating significant cost and time. The researchers trained in the Hub will have the skills and experience required by industry to transfer and implement these technologies in practice.

Healthcare Providers
It is recognised that in some diseases only 20-30% of patients are effectively treated by the standard treatment care and that there may be serious adverse reactions among those that are not. This represents a very significant wasted resource in time and materials for healthcare providers under enormous pressure to reduce costs. Targeted medicines are designed to match effective treatments to patients but this promise can only be delivered if new therapies can be developed more quickly than currently and if they have greater cost effectiveness including lower manufacturing costs than existing medicines. The processes and decision-support tools developed in the Hub will enable product manufacturers to meet these challenges.

Patients
Faster development and more economic processes for targeted therapeutics will allow the promise of precision to be realised for the patient. They will enable patients to access promptly new stratified and personalised therapies, in some cases for diseases not currently treated and they will reduce ineffective treatments and adverse side effects.

UK Economy
The UK has a strong established pharmaceutical industry and a growing number of new companies developing new protein and cellular therapies. The development of new processes and tools to guide selection of processes and manufacturing option will enable this sector to commercialise successfully their rapidly increasing research effort in targeted medicines and increase the GVA of this part of the pharmaceutical industry.

HOW WILL THEY BENEFIT FROM THE RESEARCH
The Grand Challenge research in the hub will create new process technologies to address key manufacturing challenges identified following extensive discussion with the industry. Additionally the Hub with create new decision-support tools that will be used to accelerate the development and optimisation of manufacturing processes at appropriate scales. These tools will address the complexity of new clinical trial structures and increasingly decentralised manufacturing.

User-led feasibility projects with companies of the User Group, part of the Hub's platform research, will help test and evaluate these products. The Hub will have IP arrangements designed to achieve rapid exploitation and broad uptake and will involve three Catapults to facilitate translation of the technologies developed to market. 18 PDRAS, 28 CDT, 23 PhD and 14 EngD researchers on projects aligned to the hub will be trained with the process development skills required by industry. The Hub will engage with regulators to ensure they are briefed and informed on the emerging new technologies to allow appropriate regulatory strategies to be developed and put in place.

The successful commercialisation of new targeted biological medicines by companies will strengthen the UK manufacturing community with direct impacts on people employed and UK wealth generated.

Organisations

Publications

10 25 50
 
Description The Hub has embarked on an ambitious set of strategic research targets, closely informed by its strong industry and regulatory consortium. Our focus is to develop and examine technological solutions for the rapid realization of targeted healthcare and include: pioneering studies in the utility of cell-free synthesis for just-in-time manufacture of valuable therapeutics; engineering characterization of novel bioreactor geometries for effective process development and delivery of cell and gene therapy products; as well as advanced software tools to help in decision-making for the industry.

Over the past year, we have made significant advances in our scientific understanding and technology innovations, and we are now working closely with our user community to deliver user feasibility studies which are designed to test our methods, and to gauge the utility of new approaches in an industrial setting. Already we have the first batch of nine such studies defined and approved for execution within the next 12 months. The results of these studies will be used to inform new research directions and to further our understanding of the evolving manufacturing landscape. This close integration with industry means that our progress makes a defined impact on manufacturing practice.
Exploitation Route User-led feasibility studies, Spinouts, open source software
Sectors Healthcare,Manufacturing, including Industrial Biotechology,Pharmaceuticals and Medical Biotechnology

 
Description Public dissemination and debate of key issues surrounding personalized medicines
First Year Of Impact 2017
Sector Healthcare,Manufacturing, including Industrial Biotechology,Pharmaceuticals and Medical Biotechnology
Impact Types Societal,Policy & public services

 
Description Advsory Board for reviewww of Defence Academy
Geographic Reach National 
Policy Influence Type Participation in a national consultation
 
Description Attendance of EPSRC Centre for Innovative Manufacturing in Food, Advisory Board
Geographic Reach National 
Policy Influence Type Participation in a advisory committee
 
Description BSI Commitee member
Geographic Reach National 
Policy Influence Type Membership of a guideline committee
 
Description CCMI Scale-Up and Challenges in Manufacturing of ATMP workshop
Geographic Reach Europe 
Policy Influence Type Influenced training of practitioners or researchers
 
Description Committee Member, Institution of Chemical Engineers Biochemical Engineering Special Interest Group
Geographic Reach Multiple continents/international 
Policy Influence Type Participation in a advisory committee
Impact The IChemE BESIG committee focuses on addressing and representing the Biochemical Engineering interests for the Institution of Chemical Engineers. As a member on the committee, I represent the cell and gene therapy activity which aligns with the Hub. As part of the committee, we have contributed to the Institution's BioFutures agenda which has been forwarded to government. This calls for action to boost the skills diversity of biochemical engineering graduates to prepare them for the greater diversity of roles requiring biochemical engineers.
 
Description EPSRC SAN
Geographic Reach National 
Policy Influence Type Participation in a advisory committee
Impact The EPSRC SAN is instrumental in helping the Council to formulate its research funding priorities
 
Description ESACT-UK Scientific Programme Lead
Geographic Reach Europe 
Policy Influence Type Participation in a advisory committee
Impact ESACT-UK is the UK Society for Cell Culture Biotechnology. Dr Qasim Rafiq leads up the Scientific Programme for the society. The society promotes the communication of knowledge and experience between scientists and engineers whose work has a direct or indirect bearing on cell culture biotechnology and the products derived from it. A particular emphasis is to ensure both the inclusion, and the active participation, of less experienced scientists in industry or academic institutions. ESACT-UK actively encourages interactions between academia, governmental and policy making agencies, and the manufacturing and service industries. One product of such interactions, which involved members of ESACT-UK, is the international Good Cell Culture Practice (GCCP) Guidance Document.
 
Description Elected Management Board Member of BBSRC BioProNet
Geographic Reach National 
Policy Influence Type Membership of a guideline committee
Impact BioProNet coordinates the entire UK academic and industrial community for Bioprocess Manufacturing, via network meetings, workshops and managed proof of concept funding. Research outputs feed into larger InnovateUK proposals.
 
Description Member, BIA (BioIndustry Association) Cell and Gene Therapy Advisory Committee (biannual)
Geographic Reach Multiple continents/international 
Policy Influence Type Participation in a advisory committee
Impact The Committee is linked to implementing recommendations from the MMIP Advanced Therapies Taskforce e.g. to encourage manufacturing of cell and gene therapies to stay in the UK.
 
Description Member, BIA (BioIndustry Association) Manufacturing Advisory Committee for Bioprocessing Industries (2009 - present)
Geographic Reach National 
Policy Influence Type Participation in a advisory committee
Impact A skills initiative was established with the 1st cohort 16-17 and the 2nd cohort 17-18. This aims to build a network of next generation bioprocess leaders, giving them an opportunity to visit each other's facilities for a day to learn about manufacturing of different medicine types. The programme to take place over 12 months. All companies and organisations taking part host a visit.
 
Description Member, BioIndustry Association (BIA) Cell and Gene Therapy Advisory Commitee
Geographic Reach Multiple continents/international 
Policy Influence Type Participation in a advisory committee
Impact The BIA CGTAC is a nationally leading committee in the cell and gene therapy field which has significant national and international influence. It has been involved in implementing the MMIP Advanced Therapies Taskforce and within the committee we have developed a series of four explainer booklets and five videos that highlight and celebrate the the work taking place in UK bioscience companies to create innovative new drugs and treatments for patients. This includes a Guide to Cell and Gene Therapy and UK Excellence in the Field aimed at policy makers and the public, which was published as part of this series.
 
Description Member, ISCT (International Society for Cellular Therapy) Business Models and Investment Subcommittee
Geographic Reach Multiple continents/international 
Policy Influence Type Participation in a advisory committee
Impact Cell therapy products are frequently developed and produced without incorporating cost considerations into process development, contributing to prohibitively costly products. Herein we contextualize individual process development decisions within a broad framework for cost efficient therapeutic manufacturing. This roadmap guides the analysis of Cost of Goods (COG) arising from tissue procurement, material acquisition, facility operation, production, and storage. Planning and accounting for COG at each step in the production process could reduce costs, allowing for more affordable market pricing to improve the long term viability of the cell therapy product and facilitate broader patient access to novel and transformative cell therapies.
 
Description Membership of a guideline committee - Elected Management Board Member of BBSRC BioProNet (2015)
Geographic Reach National 
Policy Influence Type Membership of a guideline committee
Impact BioProNet is key to advising and shaping the funding opportunities between BBSRC and EPSRC
 
Description UCL Cell and Gene Therapy MBI Course
Geographic Reach Multiple continents/international 
Policy Influence Type Influenced training of practitioners or researchers
Impact The UCL Cell and Gene Therapy MBI course was designed to align with the Hub activity in mind to address the arising skills gap within the advanced therapy sector. The course is specifically aimed at industrial delegates to provide them with the necessary depth and breadth to address the manufacturing and commercialisation issues associated with these advanced therapies. Over 30 industrial delegates were present for the 3 day course representing large pharmaceutical companies (e.g. GSK), SMEs (e.g. ReNeuron) and also regulatory agencies and representatives from multiple countries including Hong Kong, Qatar and Brunei.
 
Description Advanced Co-Formulation of Targeted Biologic Therapeutics
Amount £2,000 (GBP)
Organisation University of Nottingham 
Sector Academic/University
Country United Kingdom
Start 08/2018 
End 07/2019
 
Description Autolus EngD Studentship
Amount £54,000 (GBP)
Organisation Autolus Limited 
Sector Private
Country United Kingdom
Start 10/2018 
End 09/2022
 
Description CONCORD: CO-ordiNated Care Of Rare Diseases
Amount £732,217 (GBP)
Funding ID HS&DR/16/116/82 
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start 06/2018 
End 11/2020
 
Description Centre of Excellence
Amount £1,393,742 (GBP)
Organisation PALL Europe 
Sector Private
Country United Kingdom
Start 01/2018 
End 12/2024
 
Description GCRF establishment of biopharmaceutical and animal vaccine production capacity in Thailand and neighbouring South East Asian countries
Amount £4,090,773 (GBP)
Funding ID BB/P02789X/1 
Organisation Biotechnology and Biological Sciences Research Council (BBSRC) 
Sector Public
Country United Kingdom
Start 10/2017 
End 12/2021
 
Description H2020 Marie Sklodowska-Curie Innovative Training Network Grant
Amount £3,991,008 (GBP)
Funding ID 812909 
Organisation Marie Sklodowska-Curie Actions 
Sector Academic/University
Country Global
Start 02/2019 
End 02/2023
 
Description High-throughput directed evolution to engineer thermostable therapeutic proteins
Amount € 195,454 (EUR)
Funding ID 795539 
Organisation Marie Sklodowska-Curie Actions 
Sector Academic/University
Country Global
Start 07/2018 
End 07/2020
 
Description Industrial Fellowship - Carlos Julia - Aglaris
Amount £110,672 (GBP)
Organisation Royal Commission for the Exhibition of 1851 
Sector Charity/Non Profit
Country United Kingdom
Start 10/2018 
End 09/2021
 
Description Industrial Fellowship - Shaun Mansfield Biovault Technical
Amount £109,490 (GBP)
Organisation Royal Commission for the Exhibition of 1851 
Sector Charity/Non Profit
Country United Kingdom
Start 10/2017 
End 09/2020
 
Description Innovate UK
Amount £952,551 (GBP)
Funding ID 6667 
Organisation Innovate UK 
Sector Public
Country United Kingdom
Start 06/2018 
End 05/2020
 
Description InnovateUK Collaborative R&D
Amount £545,024 (GBP)
Funding ID 104377 
Organisation Innovate UK 
Sector Public
Country United Kingdom
Start 07/2018 
End 09/2019
 
Description InnovateUK KTP with Biovault Technical
Amount £307,617 (GBP)
Funding ID KTP011128 
Organisation Innovate UK 
Sector Public
Country United Kingdom
Start 04/2019 
End 04/2022
 
Description Knowledge Transfer Partnership
Amount £286,705 (GBP)
Funding ID KTP011678 
Organisation Innovate UK 
Sector Public
Country United Kingdom
Start  
 
Description New Industrial Systems: Optimising Me Manufacturing Systems
Amount £1,520,745 (GBP)
Funding ID EP/R022534/1 
Organisation Engineering and Physical Sciences Research Council (EPSRC) 
Sector Academic/University
Country United Kingdom
Start 02/2018 
End 09/2020
 
Description Responsive Mode Manufacturing the Future
Amount £406,203 (GBP)
Funding ID EP/R031649/1 
Organisation Engineering and Physical Sciences Research Council (EPSRC) 
Sector Academic/University
Country United Kingdom
Start 12/2018 
End 11/2021
 
Description Sartorius EngD Studentship
Amount £50,000 (GBP)
Organisation Sartorius Stedim Biotech 
Sector Private
Country France
Start 10/2017 
End 09/2020
 
Description The Effect of Feed Quality Due to Clarification Strategy on the Design and Performance of Protein A Periodic Counter-Current Chromatography
Amount £95,716 (GBP)
Organisation 3M 
Sector Private
Country United States
Start 05/2017 
End 11/2017
 
Description The Future Vaccine Manufacturing Research Hub (Vax-Hub)
Amount £6,968,180 (GBP)
Funding ID EP/R013756/1 
Organisation Engineering and Physical Sciences Research Council (EPSRC) 
Sector Academic/University
Country United Kingdom
Start 04/2018 
End 03/2021
 
Description The Pluripotent Stem Cells and Engineered Cell (PSEC) Hub
Amount £4,095,179 (GBP)
Funding ID MR/R015724/1 
Organisation Medical Research Council (MRC) 
Sector Academic/University
Country United Kingdom
Start 06/2018 
End 05/2023
 
Description UCL-MedImmune Centre of Excellence
Amount £667,000 (GBP)
Organisation MedImmune Ltd 
Sector Private
Country United Kingdom
Start 09/2017 
End 12/2020
 
Description Unitive Design Analysis EngD Studentship
Amount £40,000 (GBP)
Organisation Unitive Design and Analysis, Ltd. 
Start 10/2018 
End 09/2022
 
Title Cost of development model 
Description A cash-flow spreadsheet model capturing different costs occurring during research, development, regulatory approval and commercialisation of a new therapeutic drug. 
Type Of Material Computer model/algorithm 
Year Produced 2019 
Provided To Others? No  
Impact The model offer the ability to estimate the expected net present value of different manufacturing and business strategies and identify the optimum. 
 
Title Techno-economic engine for autologous cell therapies 
Description An object-oriented model to simulate technical and financial aspects in bioprocessing for autologous cell therapies. The model offers the ability to simulate the manufacture of CAR-T therapies and evaluate multiple manufacturing strategies considering different process flowsheets. 
Type Of Material Computer model/algorithm 
Year Produced 2019 
Provided To Others? No  
Impact Alternative technologies (e.g integrated systems, rocking motion bioreactors, hollow fibre bioreactors) can be rapidly evaluated under technical and financial criteria and determine their fit into a manufacturing facility. Additionally, key cost driver can be identified along with the necessary process improvements to design a feasible and cost-effective manufacturing process. 
 
Title Techno-economic engine for biopharmaceuticals 
Description An object-oriented model to simulate technical and financial aspects in bioprocessing for therapeutic proteins. The model offers the ability to simulate the manufacture of different therapeutic proteins (e.g. monoclonal antibodies, antibody drug conjugates, fusion proteins etc.) and evaluate multiple manufacturing strategies considering different process flowsheets (cell culture, cell-free synthesis, chromatographic purification, column-free purification etc.) and modes of operation (batch, fed-batch, perfusion, hybrids). Additionally, the model offers the option to simulate multiple process flowsheets in the same manufacturing facility. 
Type Of Material Computer model/algorithm 
Year Produced 2018 
Provided To Others? No  
Impact Alternative technologies (e.g cell-free synthesis) can be rapidly evaluated under technical and financial criteria and determine their fit into a manufacturing facility. Additionally, key cost driver can be identified along with the necessary process improvements to design a feasible and cost-effective manufacturing process. 
 
Description Access to HDX MS at LGC 
Organisation LGC Ltd
Country United Kingdom 
Sector Private 
PI Contribution UCL produces protein formulations to be further analysed at LGC. We have also helped LGC to develop the capability for HDX on solid state (freeze-dried) materials.
Collaborator Contribution LGC have provided access to their Mass spectrometry facility, particularly to carry out HDX and peptide mapping of proteins and their formulations.
Impact LGC have trained two PhD students - both funded by the EPSRC CDT, and also one PDRA from the EPSRC Hub. They have also provided access to their facilities to carry out a large body HDX peptide mapping for GCSF and IgG formulations.
Start Year 2016
 
Description Characterisation of degradations in biotherapeutics coformulation 
Organisation MedImmune
Department MedImmune Cambridge
Country United Kingdom 
Sector Private 
PI Contribution The co-formulation of biotherapeutics has been researched as a form of drug combination product which brings conveniences of storage and administration. We study the analytics and control strategy for degradation in coformulated therapeutic proteins, primarily antibodies, using a range of biophysical techniques.
Collaborator Contribution MedImmune provides three antibodies under the MTA framework. The materials provided by MedImmune will be mixed into ratios for aggregation study in our team.
Impact Aggregation kinetics of these MedImmune antibodies is studied at the moment. The prelimarily result shows a concentration-dependent kinetics of aggregation for some of these antibodies. Another therapeutic proteins which is previously shown to be aggregation-inhibitory will be mixed with MedImmune antibodies to test if the aggregation can be prevented.
Start Year 2018
 
Description Dissemination events & workshops with KTN & BIA 
Organisation BioIndustry Association
Country United Kingdom 
Sector Private 
PI Contribution We have run at least one workshop/event per year in partnership with the team at KTN Health and BIA (see Engagement Activities)
Collaborator Contribution Support for co-sponsored networking events, dissemination using media channels, dissemination using database of bioscience companies, provision of sector input, use of MeetingMojo software
Impact (1) Vaccine Development Workshop, 6th September 2017, London (2) Manufacturing ATMPs: moving from approvable to commercial success, 18th September 2018, London
Start Year 2017
 
Description Dissemination events & workshops with KTN & BIA 
Organisation Knowledge Transfer Network
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution We have run at least one workshop/event per year in partnership with the team at KTN Health and BIA (see Engagement Activities)
Collaborator Contribution Support for co-sponsored networking events, dissemination using media channels, dissemination using database of bioscience companies, provision of sector input, use of MeetingMojo software
Impact (1) Vaccine Development Workshop, 6th September 2017, London (2) Manufacturing ATMPs: moving from approvable to commercial success, 18th September 2018, London
Start Year 2017
 
Description Industry partnership for materials from UCB Pharma 
Organisation UCB Pharma
Country United Kingdom 
Sector Private 
PI Contribution We analysed the aggregation behaviour of a Fab protein obtained from UCB Pharma under a wide range of conditions. This has provided general information on the aggregation mechanisms, formulations and stabilising factors in Fab molecules, useful for therapeutic formulations and bioprocessing.
Collaborator Contribution UCB Pharma provided an E. coli strain that produces the A33 Fab fragment. They also provided advice for its expression and analysis.
Impact Scientific outputs on formulation of Fab and understanding of aggregation mechanisms. The access to this material has also enabled us to develop novel analytical techniques in other grants. The partnership has also led to three CASE-PhD collaborations with UCB in 2017.
Start Year 2011
 
Description Materials and facility access from NIBSC 
Organisation National Institute for Biological Standards and Control (NIBSC)
Country United Kingdom 
Sector Public 
PI Contribution We analysed the aggregation behaviour, and stability of a GCSF protein and mutants of this, obtained from NIBSC under a wide range of formulations. This has provided general information on the aggregation mechanisms, formulations and stabilising factors in GCSF molecules, useful for therapeutic formulations and bioprocessing.
Collaborator Contribution NIBSC provided an E. coli strain that produces the GCSF. They also provided advice for its expression and analysis. They also provided access to NMR, pilot-scale freeze dryers, Karl Fischer analysis, biological potency assays, and Mass spectrometry.
Impact This partnership has involved one EPSRC EngD, one BBSRC PhD, and two EPSRC CDT PhD students, formal partnership and strategic advice for the EPSRC Formulation project, Centre for Innovative Manufacturing and Future Targeted Healthcare Manufacturing Hub, as well as attendance by NIBSC at Hub events and workshops. The partnership is multi-disciplinary, bringing together protein biophysics (UCL), protein engineering (UCL), protein aggregation (UCL), freeze-drying (NIBSC), biological assays (NIBSC), NMR (NIBSC) and Mass spectrometry (NIBSC). Outputs therefore include, 3 graduated PhD/EngDs, 1 PhD currently running, 3 PDRAs receiving training and carrying out work in NIBSC facilities, 5 co-authored publications.
Start Year 2007
 
Description Stability of coformulated biotherapeutics in the presence of serum albumin 
Organisation Albumedix Ltd
Country United Kingdom 
Sector Private 
PI Contribution The co-formulation of biotherapeutics has been researched as a form of drug combination product which brings conveniences of storage and administration. However, the mixture of therapeutic proteins could lead to co-aggregation and reduced shelf life. Human serum albumin (HSA) is a widely used protein stabilising biologics in many formulations. We investigate whether HSA can aid the stability of biotheraputics in co-formulations.
Collaborator Contribution Albumedix provides the HSA material under MTA framework for us to make analysis.
Impact The mixture of HSA and antibodies has been created under a few pH conditions. The prelimarily data shows HSA cannot be separated using SEC-HPLC from antibodies. Therefore, other form of separation such as HIC and RP-HPLC are under investigation.
Start Year 2017
 
Description The EPSRC Future Manufacturing Hub for Targeted Healthcare (whole project) 
Organisation University College London
Department Biochemical Engineering
Country United Kingdom 
Sector Academic/University 
PI Contribution The Hub is working with its network of users and academics to deliver the vision, with the core research focusing on: Grand Challenge 1: Transforming supply chain management and economics for targeted biotherapeutics with novel computational decision-support tools Grand Challenge 2: Sustainable manufacturing for future targeted biotherapeutics with novel bioprocesses, analytics and control algorthims This paradigm shift in manufacturing practice will provide the manufacturing infrastructure needed for sustainable healthcare
Collaborator Contribution The Hub's research is being supported by a User Steering Committee of over 35 industrial users and sector organisations to revolutionise the delivery of cost-effective stratified protein-based and personalised cell-based therapies to patients. The Hub User Steering Committee provides advice and guidance on the overall direction and progress of the Hub research.
Impact (see ResearchFish)
Start Year 2017
 
Description 1-Day Teaching Seminar in Microfluidics 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Postgraduate students
Results and Impact Together with an industrial partner in microfabrication, I taught a one day seminar in microfluidics ahead of the Lab on Chip conference in Mumbai, India, 2018.
Year(s) Of Engagement Activity 2018
URL https://selectbiosciences.com/conferences/index.aspx?conf=MLOAC18
 
Description 1st International Training Course - Application of microbioreactors (MBR) in bioprocess development. September 24-28, 2018, TU Braunschweig, Germany http://www.eurombr.nu/ 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Postgraduate students
Results and Impact 5-day training course with lecture programme and laboratory hands-on
Topics:
- Microfabrication
- Microfluidics, Transport phenoma, Fluid flow - Sensors and Inline-Analytics
- Enzyme immobilisation
- Biocatalysis
- Cultivation
- Modeling and Design of microfluidic processes
Year(s) Of Engagement Activity 2018
URL http://www.eurombr.nu/
 
Description A specialist working group (SWG) on cell free synthesis (CFS). 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact A specialist working group (SWG) on cell free synthesis (CFS).
The group meets twice a year to discuss the challenges of using CFS as a platform for biotherapeutic manufacture to meet the needs of targeted healthcare.
This is an important activity within the EPSRC Future Targeted Healthcare Manufacturing hub (https://www.ucl.ac.uk/biochemical-engineering/research/hub).
Bringing together supplier and user companies to consider the challenges and possibilities in the area.
The scope is from the experimental challenges to costing and regulatory issues.
Year(s) Of Engagement Activity 2017,2018,2019
 
Description BioProNet Bioprocess Intensification Symposium 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact BioProNET Bioprocess Intensification Symposium
4th July 2018
The continued growth of the biopharmaceutical industry is being challenged by a greater number and variety of products than in the past. The industry is also increasingly concerned with the affordability of these products. These key factors means process intensification has become a critical objective. The goal is higher productivity processes to enable small process trains, resulting in cost-effective, lean, and agile manufacturing facilities. The symposium assembles 8 leaders from the biopharmaceutical industry and academia who will present their latest findings and opinions on the subject. By bringing together scientists and engineers from academia and industry who are actively engaged in bioprocess intensification the event will provide forum for lively debate.
Year(s) Of Engagement Activity 2018
URL http://biopronetuk.org/biopronet-funded-collaboration-building-workshops/
 
Description Bioprocess Asia Conference 
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 BPA is an international conference and I am part of the Scientific Advisory Committee
Year(s) Of Engagement Activity 2018
 
Description Bioprocessing Skills School (STARS) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Industry/Business
Results and Impact Ran half-day session entitled "Innovative therapies but what about the societal and economic implications", introducing health economic concepts and thinking to participants.
Year(s) Of Engagement Activity 2017
 
Description Chair for the Young Members Forum of London and South East Coast IChemE 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Professional Practitioners
Results and Impact Since October 2018 I am chairing the Young Members Forum of London and South East Coast IChemE organisign events that are related and targeted to:

- Undergraduate Chemical Engineering students
- Postgraduate Chemical Engineering students
- Chemical Engineering professionals

I am actively involved in initiating and supporting networking activities, educative pilot plant tours and social activities amongst the group members and beyond.
Year(s) Of Engagement Activity 2018,2019
 
Description Decisional Tools Specialist Working Group 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact The Decisional Tools Specialist Working Group (SWG) has met x2 a year since the Hub launch, The SWG discusses the use of Hub Decisional Tools to aid decision-making in the development, manufacture and commercialisation of autologous cell therapies and stratified therapies and includes invited user expert presentations. The aim of this specialist working group meeting is to:
Assess whether decisional tools research plans are addressing the key challenges within stratified protein therapies and personalised cell therapies.
Identify any emerging areas, or current weaknesses in the proposal.
Identify key materials and resources required for the projects proposed.
Evaluate potential risks to the success of the decisional tools workpackages within the Hub.
Year(s) Of Engagement Activity 2017,2018
 
Description Dolomite News 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Industry/Business
Results and Impact Featured in dolomites news article detailing the application of microfluidics for the synthesis of nano and microparticles to augment therapeutic delivery and biosensing.
Year(s) Of Engagement Activity 2019
URL https://www.dolomite-microfluidics.com/news/fluorescent-biosensors-as-tools-for-drug-therapeutics/
 
Description Formulation Specialist Working Group 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Industry/Business
Results and Impact The formulation Specialist Working Group meets every 6 months (twice in 2017, once in 2018 so far) to enable industry, regulatory agency, government laboratory and academic experts to discuss the arising challenges, and potential solutions on a 5-10 year horizon, in the area of formulation for stratified proteins, and cell and gene therapies. Over 30 different users have attended to date, and the meetings have refined the Hub research agenda, scoped out topics for review articles, and engaged the regulatory agencies which raises their awareness of future challenges that they will also need to address.
Year(s) Of Engagement Activity 2017
 
Description Formulation Specialist Working Group - 2018 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact 1. Assess the current second level plan for formulation work proposed within the Hub, in terms of whether it is addressing the key challenges within stratified protein therapy.
2. Identify any emerging areas, or current weaknesses in the proposal.
3. Identify key materials and resources required for the project proposed.
4. Evaluate potential risks to the success of the formulation workpackages within the Hub.
Year(s) Of Engagement Activity 2018
 
Description Future Food Formulations Factories 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Schools
Results and Impact University of Nottingham Student Magazine Article.

With the advent of nanotechnology and the food industry looking for novel applications to maximise the benefits of food nutrition, there have been key advancements in the nutraceutical market.

The researchers at the University of Nottingham's School of Pharmacy have an in depth understanding of the fundamental formulation parameters. We are now enhancing particle formulation by preparing custom designed polymers. These polymers permit targeted delivery of therapeutics and nutraceuticals to specific cellular systems. We believe that the research being conducted at our school is paving the way to transform food security of an ever-growing world population with a limited number of resources
Year(s) Of Engagement Activity 2018
URL https://impactnottingham.com/2018/04/future-food-factories/
 
Description Healthcare Specialist Working Group 
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 Healthcare Specialist Working Group involving round table discussions with health care providers, policy makers and industry about reimbursement of personalised cell therapies and stratified medicines.
Year(s) Of Engagement Activity 2017,2018
 
Description Industry-Academia Networking Event on Application of Artificial Intelligence & Big Data for Early Cancer Detection 
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 activity was related to meet people from Academia and from Industry on Application of AI and Big Data.
It is annual event international event on front edge techniques like AI/Big Data used in Medicine and in Academia research for Early Cancer Detection.
I was there to understand potential of Quantative Phase Microscopy combined with mashine learning techniques for early cancer detection and the routes how to build up AI apropriate algorithms.
Year(s) Of Engagement Activity 2019
 
Description Invited Interview 
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 Professional Practitioners
Results and Impact "Advances in enabling smart technologies across the cell therapy supply chain", Cell and Gene Therapy Insights
Year(s) Of Engagement Activity 2018
URL https://insights.bio/cell-and-gene-therapy-insights/journal/articles/advances-in-enabling-smart-tech...
 
Description Invited Seminar 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Other audiences
Results and Impact Invited seminar at the Texas A&M Energy Institute with title "Pharma 4.0: Advancing the current state of the art through Process Systems Engineering approaches". More than 50 people attended, coming from all academic levels (UG to faculty), as well as a few industrial practitioners. Most of the interested was raised around the unique challenges faced in the design and optimisation of the supply chain of CAR T cell therapies. My talk initiated further conversations with members of the faculty and I am now exploring how those can move forward.
Year(s) Of Engagement Activity 2018
URL https://energy.tamu.edu/events/energy-institute-lecture-series-dr-maria-m-papathanasiou/
 
Description Lecture at skills workshop 
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 Presented workshop at STARS Bioprocessing Skills School. "Innovative therapies but what about the societal and economic implications: Building a compelling case - making the health economics stack up." Darlington, September 2018.
Year(s) Of Engagement Activity 2018
URL http://biopronetuk.org/stars-school-2018-embedding-the-industrial-perspective/
 
Description Manufacturing ATMPs: moving from approvable to commercial success 
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 Hub and KTN partnered to deliver this meeting enabling industry and academia engagement and collaboration, and showcasing of the relevant translational research being undertaken by the Hub in collaboration with industry. The focus of this meeting was on the current UK innovation landscape for advanced therapies, in support of enabling gene and cell therapy products to go from approvable to commercially successful; translational research projects in support of manufacturing readiness, a future looking session regarding key challenges from clinical, regulatory and skills perspectives. One of the purposes of this meeting was to promote and give an updated view of the Hub to organisations outside of the current consortium. Approx 77% of the attendees were from outside companies & organisations and we got 4 new enquiries about becoming Hub members.
Year(s) Of Engagement Activity 2018
URL https://ktn-uk.co.uk/events/manufacturing-atmps-moving-from-approvable-to-commercial-success
 
Description Manufacturing ATMPs: moving from approvable to commercial success 
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 Hub presentation on our CAR T research for this KTN event/workshop
Year(s) Of Engagement Activity 2018
 
Description News interview for Royal Society fo Chemistry (Chemistry World) on Nobel Prize Awards to Frances Arnold and Greg Winter in 2018 
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 Media (as a channel to the public)
Results and Impact Interviewed to comment on the Nobel Prize Awards to Frances Arnold and Greg Winter in 2018. Quoted in an article online and also in Chemistry World magazine published by the Royal Society of Chemistry.

https://www.chemistryworld.com/features/how-chemical-evolution-took-the-2018-chemistry-nobel-prize/3009626.article
Year(s) Of Engagement Activity 2018
 
Description News interview for the Guardian on Nobel Prize Awards to Frances Arnold and Greg Winter in 2019 
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 Media (as a channel to the public)
Results and Impact News interview for the Guardian on Nobel Prize Awards to Frances Arnold and Greg Winter in 2019. Quoted in article printed in the Guardian and online.
Year(s) Of Engagement Activity 2018
 
Description Recovery of Biological Products Board Conference Series . 
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 Chair of Recovery of Biological Products Board Conference Series . 2011- 2012 Now member of Scientific Board. The Recovery Conference Series is the premier international forum for the presentation and discussion of the status, direction and trends in the recovery of biological products of therapeutic, diagnostic and industrial value to the society.


. Awarding Body - Recovery of Biological Products Board Conference Series, Name of Scheme - Recovery of Biological Products
Year(s) Of Engagement Activity 2012,2014,2016,2018
 
Description Royal Society of Chemistry Conference Organisation 2017 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact I organised a conference for the Royal Society of Chemistry Biotechnology Group titled "Biotransformations: From Science to Industrial Application", in London. This was attended by approx 70 delegates from across academia and industry, internationally. The conference enabled discussions on the sustainable use of biomass for production of high value chemicals and biologics, including regulatory issues.
Year(s) Of Engagement Activity 2017
 
Description Spring school on 3D-printing of columns, devices and stationary materials 
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 This workshop originates in response to the increasingly significant role of Additive Manufacturing (AM, or 3D printing) in the separation sciences.

This three day course was elaborate on current work and future prospects of 3D printing. It covered the full pipeline to produce separation devices, from conceptual design to CAD modelling to manufacture using 3D printers to post-processing, evaluation and troubleshooting. Lectures on 3D printing methods, CAD design, and applications in the separation sciences will be combined with hands-on tutorials with CAD design software and practicums on 3D printers.
Year(s) Of Engagement Activity 2018
URL https://3dprintchromatographycolumns.wordpress.com/
 
Description T-cell Processing Specialist Working Group 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact The T-cell Processing Specialist Working Group (SWG) has met twice a year since the launch of the Hub. The focus of the T-cell Processing SWG is to discuss the the research activity and strategic direction of the T-cell autologous cell therapy development activity within the Hub, engaging users of their perspectives, as a platform for dissemination and ensure that the research plans are addressing key challenges within the sector. With input and presentation from Hub users (including professional practitioners from industry and the clinic) it is also used to highlight the state of the art in the sector and identify emerging areas for research exploitation and areas that need addressing. It is also designed to identify potential risks or additional work that could be undertaken in the T-cell processing work packages.
Year(s) Of Engagement Activity 2017,2018
 
Description Towards Regulatory Scenarios for Proteins and Cell Therapies: mapping the regulatory drivers and decision nodes 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact On February the 15th 2018, at the Bioengineering Department of UCL, as part of the activity of the Grand Challenge 1.2c - regulatory strategies- Giovanni De Grandis and Arthur Petersen convened a workshop bringing together junior and senior staff from the hub and some high-profile experts in biopharmaceutical regulations and policy. Through a combination of group work and presentations, the workshop performed a small-scale horizon scanning exercise, aimed at identifying regulatory challenges and opportunities for the hub.
Year(s) Of Engagement Activity 2018
 
Description UCL 3D Printing in Healthcare Research Symposium 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Postgraduate students
Results and Impact Bioprinting background, skills, facilities and contacts who worked in UCL in the field.
Year(s) Of Engagement Activity 2018
 
Description User Steering Committee Meeting 
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 This is a meeting of the whole Hub consortium - academic team, members from our Industrial and non-corporate partner organizations, independent members of our Advisory Board. The purpose of this bi-annual meeting is to provide an update on the progress of Hub research and (once a year) an update of the research in the Centres for Doctoral Training (CDT) aligned to the Hub. The format includes formal presentations, poster sessions, round-table workshop discussions and structured networking elements.
Year(s) Of Engagement Activity 2017,2018
 
Description User Steering Committee meetings 
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 User Steering Committee meeting was an excellent platform to engage industry and academics to highlight our latest research work being done in the hub. The benefit of this kind of meeting is that work groups/researchers can have interdisciplinary interactions with other scientists and provide a fresh perspective while everyone learns through the interaction. We've had overwhelmingly positive feedback from everyone involved.
Year(s) Of Engagement Activity 2016,2017,2018
 
Description Vaccines Development and Manufacturing Workshop 
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 Hub co-hosted a workshop on vaccine manufacturing and development with the KTN on 6 September 2017 at UCL. The event brought together more than 90 delegates from the vaccine development and manufacturing community in human health in the UK. Presentations were given on the latest innovative technologies, current UK capabilities, Department of Health investments to date and the work of the UK Vaccine network. It highlighted potential funding opportunities through the Industrial Strategy Challenge Fund.
Year(s) Of Engagement Activity 2017
URL https://ktn-uk.co.uk/news/the-future-of-vaccines-development-and-manufacture
 
Description Workshop "Ideas to Impact", Entrepreneurship Essentials for Researchers (SPERO) 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Industry/Business
Results and Impact A nice workshop on Entrepreneurship Essentials for Researchers (SPERO)
Year(s) Of Engagement Activity 2018