EPSRC Centre for Innovative Manufacturing in Emergent Macromolecular Therapies
Lead Research Organisation:
University College London
Department Name: Biochemical Engineering
Abstract
In the 1980s it began to be possible to produce potentially unlimited quantities of human proteins by placing the gene defining them in a simple organism such as yeast. From this grew a new kind of medicine capable of treating conditions such as severe arthritis, haemophilia, growth deficiency, and some cancers that previously had no satisfactory treatments. As well as having great clinical value the resulting technology has become the basis of a new and fastest growing part of the pharmaceutical industry, described as biopharmaceuticals. Because the molecules involved are proteins, they are orders of magnitude larger and more complex than conventional drugs such as aspirin and their processing is much more demanding. They are also so complex that they cannot in general be characterised with precision except in relation to the methods by which they are made. That means the capacity to precisely define such processes is critical to clinical safety and commercial success. Full scale trials of the processes are so costly they can only be conducted once clinical promise is established but, given the number of factors governing processing of even first generation products, there have often been hold-ups so extensive as to delay availability to patients. UCL has pioneered micro scale methods that are sufficiently good at predicting efficient conditions for large scale performance that far fewer and better focussed large scale trials suffice. That resolves part of the problem but an even greater challenge is now emerging. The early biopharmaceuticals were in general the easiest ones to produce. The final scales were also relatively modest. Now, the next generation of biopharmaceuticals are more complex materials and with rising demand the scales are far larger so that processes push the boundaries of the possible. The combined complexity of the product and the process with so many variables to consider means that the managers need better systematic means of supporting their decisions. Already the cost of developing a single biopharmaceutical can exceed 0.7 billion and take 10 years. With more advanced biopharmaceuticals these figures tend to rise and yet the world's governments are facing a healthcare cost crisis with more older people. They therefore exert pressure on companies to reduce prices. Because the public wishes to have medicines that do not pose risks, regulations become ever more stringent so they are a major factor in defining the bioprocess. This also adds to the need for managers to have sector-specific decisional-support aids well grounded in the detailed engineering of the processes. Finally, it is now possible to apply molecular engineering to proteins and vaccines to enhance their therapeutic properties but this can also cause serious bioprocessing problems. The research vision developed with detailed input from UK industry experts will apply these methods as the foundation for another step change whereby much faster and lower cost information can be gathered and integrated with advanced decisional techniques to give managers a better foundation on which to base their policies. The academic team from leading UK universities provides the necessary continuum of skills needed to assess the ease of manufacture of novel drugs, the costs of processing and of delivery to patients. We will work with companies to test the outcomes to ensure they are well proven prior to use on new biopharmaceuticals. This will cut costs so that all the patients who might benefit can receive them and at the earliest possible date achieved within the severely restricted budgets now available to the NHS.
Planned Impact
WHO WILL BENEFIT FROM THE RESEARCH? The benefits of the proposed EPSRC Centre extend beyond the users who have already declared their interests and co-developed the proposal. This is a radical new opportunity for the industry which suffers from a diminished pipeline of blockbuster drugs. UK-based companies will benefit from access to a network and research activities within the extended EPSRC Centre. The Centre approach for more efficient and early evaluation of the potential value and manufacturability of new drugs treating diseases such as severe arthritis, currently untreatable cancers and multiple sclerosis offers the possibility of rapid and effective development for new clinical therapies and promises a new horizon for the sector. The research will also allow UK companies to better understand the likely development and manufacturing costs of their medicines and the associated administration costs, and their relationship to thresholds set by healthcare providers and agencies such as NICE. Potential patients will benefit because the EPSRC Centre innovations will significantly aid reduction in development times of macromolecular medicines, which is particularly crucial for those addressing previously unmet clinical needs and the treatment of severe conditions such as arthritis and cardiovascular disease, as well as vaccines for previously unpreventable viral infections and cancers. Benefits to the NHS relate to the possibility of constraining costs. The capacity to treat conditions such as rheumatoid arthritis much more effectively in ageing populations is vital but it still poses a problem with respect to stretched NHS budgets. A significantly greater number of drugs will be capable of meeting NICE's thresholds and thus benefit extended patient populations. The UK economy will benefit because academic research will complement the country's strength in bioscience discovery. Collaboration between bioprocess engineers, process modellers and protein biophysicists will ensure effective knowledge and skills transfer between the science and engineering base and UK industry. This will expand their position in the global healthcare market and attract further R&D investment from global business which recognises the UK as a good place to conduct these activities. Such retention of expertise, know-how and intellectual property will aid the capacity to remain internationally competitive. HOW WILL THEY BENEFIT FROM THE RESEARCH? Proteins are innately complex and labile so that bioprocess development times and hence costs tend to be high due to unforeseen issues that occur during scale-up of the manufacturing processes. The research will fundamentally address the ability to experimentally evaluate new protein therapy candidates on a rapid and low-volume platform, and use this data to create indices that flag up potential issues with sequences of manufacturing and formulation process steps. Advances in process modelling, optimisation and decision making tools will allow a more effective prediction of the bioprocess manufacturability, optimum downstream process, and fit to available manufacturing platforms and facilities, for new lead protein therapy candidates. This framework will provide significant cost-savings through a screen early - fail early approach. This minimises the risk of having to absorb the cost of late-failure of candidates during manufacturing scale-up or due to a need to re-optimise a bioprocess at a late stage in development. The research will also allow UK companies to gain a better prediction of the likely baseline costs of medicines and associated administration costs of a product, and their alignment to NICE thresholds, prior to product manufacturing development. These tools will enable the UK biotechnology industry to design more efficient bioprocesses and robust protein scaffolds that fit to available manufacturing platforms.
Organisations
- University College London (Lead Research Organisation)
- BIOINDUSTRY ASSOCIATION (Collaboration)
- Polytherics (Collaboration)
- Public Health England (Collaboration)
- Lonza Group (Collaboration)
- Aegis Analytical (Collaboration)
- HealthTech and Medicines Knowledge Transfer Network (Health KTN) (Collaboration)
- Francis Biopharma (Collaboration)
- Avacta Group (Collaboration)
- UCB Pharma (Collaboration)
- PALL Europe (Collaboration)
- MERCK (Collaboration)
- Novozymes Biopharma UK ltd (Collaboration)
- Eli Lilly & Company Ltd (Collaboration)
- TAP Biosystems (Collaboration)
- GE Healthcare Limited (Collaboration)
- Novo Nordisk (Collaboration)
- EDEN Biodesign (Collaboration)
- Fujifilm (Japan) (Collaboration)
- Pfizer Ltd (Collaboration)
- LGC Ltd (Collaboration)
- Biopharm Services (Collaboration)
- National Institute for Biological Standards and Control (NIBSC) (Collaboration)
- Association of the British Pharmaceutical Industry (Collaboration, Project Partner)
- AstraZeneca (United Kingdom) (Collaboration)
- BTG (Collaboration)
- Health Protectin Agency (Project Partner)
- MSD (United States) (Project Partner)
- Novo Nordisk (Denmark) (Project Partner)
- Ipsen (United Kingdom) (Project Partner)
- Aegis Analytical Corp (Project Partner)
- Office Of Health Economics (Project Partner)
- BioIndustry Association (Project Partner)
- UCB Pharma (United Kingdom) (Project Partner)
- Lonza (United Kingdom) (Project Partner)
- General Electric (Sweden) (Project Partner)
- GlaxoSmithKline Res and Dev (Project Partner)
- Pfizer R&D Global Biologics (Project Partner)
- NHS Improvement - QIPP (Project Partner)
- Novozymes (United Kingdom) (Project Partner)
- National Institute for Biological Standards and Control (Project Partner)
- Francis Biopharma Ltd (Project Partner)
- BioPharm (United Kingdom) (Project Partner)
- Eli Lilly (Ireland) (Project Partner)
- Avacta (United Kingdom) (Project Partner)
- HealthTech and Medicines KTN (Project Partner)
- BTG International (United Kingdom) (Project Partner)
- AstraZeneca (United Kingdom) (Project Partner)
- MSD (United Kingdom) (Project Partner)
- Sartorius (United Kingdom) (Project Partner)
Publications
Ahmad SS
(2011)
Thermodynamic parameters for salt-induced reversible protein precipitation from automated microscale experiments.
in Biotechnology and bioengineering
Al-Obaidi H
(2011)
Characterization and stability of ternary solid dispersions with PVP and PHPMA
in International Journal of Pharmaceutics
Ali S
(2012)
Characterization and feasibility of a miniaturized stirred tank bioreactor to perform E. coli high cell density fed-batch fermentations.
in Biotechnology progress
Allmendinger R
(2014)
Multiobjective evolutionary optimization in antibody purification process design
in Biochemical Engineering Journal
Allmendinger R
(2014)
Parallel Problem Solving from Nature - PPSN XIII
Allmendinger R
(2014)
Parallel Problem Solving from Nature - PPSN XIII
Balasundaram B
(2013)
Study of the conditions for multi-modal chromatographic capture of Fab' from dual-salt precipitated E. coli homogenate Chromatographic capture of Fab' from dual-salt precipitated E. coli homogenate
in Journal of Chemical Technology & Biotechnology
Balasundaram B
(2011)
Dual salt precipitation for the recovery of a recombinant protein from Escherichia coli.
in Biotechnology progress
Barata T
(2011)
Computational design principles for bioactive dendrimer based constructs as antagonists of the TLR4-MD-2-LPS complex.
in Biomaterials
Barata TS
(2011)
From sequence to 3D structure of hyperbranched molecules: application to surface modified PAMAM dendrimers.
in Journal of molecular modeling
| Description | We have created methods by which industry can decide upon appropriate candidates to take forward for manufacture and to ensure costs are such that the NHS can afford them. |
| Exploitation Route | Spinouts, IP ad Patents |
| Sectors | Healthcare,Manufacturing, including Industrial Biotechology,Pharmaceuticals and Medical Biotechnology |
| Description | Demonstration projects have been used to export ideas into industry. |
| Sector | Healthcare,Manufacturing, including Industrial Biotechology,Pharmaceuticals and Medical Biotechnology |
| Impact Types | Economic |
| Description | BSI Commitee member |
| Geographic Reach | National |
| Policy Influence Type | Membership of a guideline committee |
| Description | Chair of the Royal Society of Chemistry Biotechnology Interest Group |
| Geographic Reach | National |
| Policy Influence Type | Membership of a guideline committee |
| Impact | The RSC BTG committee responds to the community of Chemists working in the area of biotechnology (in its broadest definition). The committee runs symposia, conferences and training events that fit the needs of its community. |
| Description | Committee Member of the RSC Chemistry Biology Interface Division |
| Geographic Reach | National |
| Policy Influence Type | Membership of a guideline committee |
| Impact | The RSC CBID committee reviews Research Council strategy and opportunities in consultation with the UK Chemistry community. |
| 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 | 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 | BBSRC BRIC |
| Amount | £430,000 (GBP) |
| Funding ID | BB/K011162/1 |
| Organisation | Biotechnology and Biological Sciences Research Council (BBSRC) |
| Sector | Public |
| Country | United Kingdom |
| Start | 06/2013 |
| End | 10/2016 |
| Description | BBSRC US Partnering |
| Amount | £43,192 (GBP) |
| Funding ID | BB/K021354/1 |
| Organisation | Biotechnology and Biological Sciences Research Council (BBSRC) |
| Sector | Public |
| Country | United Kingdom |
| Start | 05/2013 |
| End | 12/2016 |
| Description | Centre of Doctoral Trainining (CDT) |
| Amount | £2,408,757 (GBP) |
| Funding ID | EP/K503332/1 |
| Organisation | Engineering and Physical Sciences Research Council (EPSRC) |
| Sector | Public |
| Country | United Kingdom |
| Start | 05/2011 |
| End | 09/2019 |
| Description | EPSRC CDT equipment |
| Amount | £240,691 (GBP) |
| Funding ID | EP/K005030/1 |
| Organisation | Engineering and Physical Sciences Research Council (EPSRC) |
| Sector | Public |
| Country | United Kingdom |
| Start | 03/2014 |
| End | 03/2015 |
| Description | EPSRC Capital Equipment (Freeze-drying) |
| Amount | £520,000 (GBP) |
| Funding ID | EP/M028100/1 |
| Organisation | Engineering and Physical Sciences Research Council (EPSRC) |
| Sector | Public |
| Country | United Kingdom |
| Start | 03/2015 |
| End | 03/2016 |
| Description | EPSRC Centre for Doctoral Training |
| Amount | £3,710,000 (GBP) |
| Funding ID | EP/L015218/1 |
| Organisation | Engineering and Physical Sciences Research Council (EPSRC) |
| Sector | Public |
| Country | United Kingdom |
| Start | 09/2015 |
| End | 08/2022 |
| Description | EPSRC Centre for Doctoral Training 2012 |
| Amount | £2,410,000 (GBP) |
| Funding ID | EP/K503332/1 |
| Organisation | Engineering and Physical Sciences Research Council (EPSRC) |
| Sector | Public |
| Country | United Kingdom |
| Start | 09/2012 |
| End | 08/2019 |
| Description | EPSRC Formulation |
| Amount | £2,961,745 (GBP) |
| Funding ID | EP/N025105/1 |
| Organisation | Engineering and Physical Sciences Research Council (EPSRC) |
| Sector | Public |
| Country | United Kingdom |
| Start | 10/2016 |
| End | 09/2021 |
| Description | Future Manufacturing Hubs |
| Amount | £10,000,000 (GBP) |
| Funding ID | EP/P006485/1 |
| Organisation | Engineering and Physical Sciences Research Council (EPSRC) |
| Sector | Public |
| Country | United Kingdom |
| Start | 01/2017 |
| End | 12/2024 |
| Description | UCL-MedImmune Centre of Excellence |
| Amount | £800,000 (GBP) |
| Organisation | AstraZeneca |
| Department | MedImmune |
| Sector | Private |
| Country | United Kingdom |
| Start | 09/2014 |
| End | 09/2017 |
| Title | Decisional Tools - Bioprocess Lifecycle Optimisation Tools and Facility Fit Tools |
| Description | A suite of decisional tools were created to assist with decision-making related to cost-effective bioprocess design through to facility fit prediction. Bioprocess lifecycle optimisation: A framework consisting of an evolutionary multiobjective optimization algorithm (EMOA) linked to a biomanufacturing process economics model has been created for designing more cost-ef?cient, robust and ?exible downstream processes for the manufacture of monoclonal antibodies (mAbs). The tool is tuned to discover sequences of chromatographic puri?cation steps and column sizing strategies that provide the best trade-off with respect to multiple objectives including cost of goods per gram (COG/g), robustness in COG/g, and impurity removal capabilities. Additional complexities accounted for by the framework include the topical decisions of whether to opt for batch or continuous processes and disposable or reusable equipment, as well as uncertainties and constraints. The framework is validated on industrially relevant case studies for therapeutic antibody manufacture varying in upstream and downstream processing train ratios, annual demands, and impurity loads. Results obtained by the framework are presented using a range of visualization tools, and indicate that uncertainty can cause otherwise optimal processes to become suboptimal. The optimal puri?cation processes discovered outperform the industrial standard with significant savings in COG/g. Guidelines are provided for choosing an optimal puri?cation process as a function of the objectives being optimized and impurity levels present. Facility fit prediction: Higher titre processes can pose facility ?t challenges in legacy biopharmaceutical puri?cation suites with capacities originally matched to lower titre processes. Bottlenecks caused by mismatches in equipment sizes, combined with process ?uctuations upon scale-up, can result in discarding expensive product. A data mining decisional tool was created for rapid prediction of facility ?t issues and debottlenecking of biomanufacturing facilities exposed to batch-to-batch variability and higher titres. The predictive tool comprised advanced multivariate analysis techniques to interrogate Monte Carlo stochastic simulation datasets that mimicked batch ?uctuations in cell culture titres, step yields and chromatography eluate volumes. A decision tree classi?cation method, CART (classi?cation and regression tree) was introduced to explore the impact of these process ?uctuations on product mass loss and reveal the root causes of bottlenecks. The resulting pictorial decision tree determined a series of if-then rules for the critical combinations of factors that lead to different mass loss levels. The tool facilitates the identification and investigation of different debottlenecking strategies and compares them in terms of mass output, direct cost of goods per gram and processing time, as well as consideration of extra capital investment and space requirements. |
| Type Of Material | Computer model/algorithm |
| Year Produced | 2016 |
| Provided To Others? | Yes |
| Impact | The bioprocess optimisation tools provided an improved understanding of the relationship and trade-off between chromatography sequence selection, type of purification platform, equipment sizing and cost of goods. Case study outputs helped to identify strategies that provide significant reductions in cost of goods and the target performance that needs to be demonstrated experimentally for new technologies to compete. This in silico prediction of optimal strategies saves precious experimental resources. The facility fit prediction tools allow prediction of the root causes of facility fit challenges, which is critical to minimising the probability of having to discard expensive product. The framework developed compares different debottlenecking solutions for sub-optimised facilities in relation to their impact on mass output, COG and processing time, as well as consideration of extra capital investment and space requirements in order to support decision making. The frame work developed explores capability of multiproduct facilities to cater for low and high concentration formulations and enables to find optimal design for different product requirements. The decisional tools research led to a number of peer-reviewed journal articles, demonstrator versions of the software with user-friendly interfaces for dissemination and knowledge transfer, user demonstration projects with companies (eg UCB, Syntaxin/Ipsen, Eden/Actavis, Repligen, Merck) with application of the tools to industry problems, new teaching materials integrated into the Masters level module Bioprocess Systems Engineering. The mid-term review panel was positive about this major theme of research: "Flagship Project 2, which seeks to establish new decisional tools for biopharmaceutical life-cycle analysis, was judged to be of outstanding quality and promise by the panel, in part because it leverages all strengths and opportunities made possible by the networked Centre concept (e.g., user partnerships, ability to test and validate models across product classes and platforms), and because it clearly builds on the research programs for which the UCL Biochemical Engineering Department is most highly regarded". Sustainability: The CIM decisional tools outputs helped to underpin the creation of a UCL-MedImmune Centre of Excellence (2014-present, £0.8M) supporting six linked EngD projects so far, coordinated by a MedImmune-funded PDRA. Having established the CoE, the CIM PDRAs played a key role in knowledge transfer to the CoE researchers and provision of access to CIM toolkits. The linked projects have drawn upon CIM tools to create novel company-specific frameworks that enhance predictability early in the drug development cycle through integration of microscale experimentation, statistical correlations and cost modelling. Impact: The benefits of leveraging CIM outputs through the creation of a UCL-MedImmune CoE span sustainability, knowledge transfer, training, savings in cost and time and priority shifts in investment decisions. |
| Description | ABPI |
| Organisation | Association of the British Pharmaceutical Industry |
| Country | United Kingdom |
| Sector | Charity/Non Profit |
| PI Contribution | Collobaring Organisation and Project Partner. The ABPI represents innovative research-based biopharmaceutical companies, large, medium and small, leading an exciting new era of biosciences in the UK. |
| Start Year | 2011 |
| Description | Access to HDX MS at LGC |
| Organisation | LGC Ltd |
| Country | Global |
| 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 | Aegis Analytical |
| Organisation | Aegis Analytical |
| Country | United States |
| Sector | Private |
| PI Contribution | Collaborating Organisation Project Partner. Aegis Analytical Corp. provides Discoverant, an Enterprise Manufacturing Process Intelligence software platform that enables manufacturers to produce regulated and specialty products more efficiently. |
| Start Year | 2011 |
| Description | Avacta |
| Organisation | Avacta Group |
| Country | United Kingdom |
| Sector | Private |
| PI Contribution | Collaborating Organisation Partner. Avacta Group plc, a UK-based healthcare technology and consumables business, provides innovative and proprietary solutions to the life sciences/healthcare sector. |
| Start Year | 2011 |
| Description | BTG PLc |
| Organisation | BTG |
| Country | United Kingdom |
| Sector | Private |
| PI Contribution | Collaborating Organisation and Project Partner. International specialist healthcare company. mission is to bring to market medical products that meet the needs of specialist healthcare physicians and their patients. |
| Start Year | 2011 |
| Description | BioPharm Services |
| Organisation | Biopharm Services |
| Country | United Kingdom |
| Sector | Private |
| PI Contribution | Collaborating Organisation and Project Partner. Biopharm Services is a bioprocess consultancy. The consultancy plus the BioSolve software help end users to make informed decisions quickly and so reduce time to market and business risk. |
| Start Year | 2011 |
| Description | EDEN |
| Organisation | EDEN Biodesign |
| Country | United Kingdom |
| Sector | Private |
| PI Contribution | Collaborating Organisation and Project Partner. Eden Biodesign is an integrated biopharmaceutical development organization and part of Watson Pharmaceuticals, Inc. |
| Start Year | 2011 |
| Description | Eli Lilly |
| Organisation | Eli Lilly & Company Ltd |
| Country | United Kingdom |
| Sector | Private |
| PI Contribution | Collaborating Organisation and Project Partner. Lilly UK provides research and development, manufacturing and commercial operations. |
| Start Year | 2011 |
| Description | Francis BioPharm Consulting |
| Organisation | Francis Biopharma |
| Country | United Kingdom |
| Sector | Private |
| PI Contribution | Collaborating Organisation and Project Partner. The companies purpose is to supply expert advice to facilitate the development of biopharmaceutical products. Specific areas of expertise include Quality by Design, Process Development, Process Validation, Process Qualification, Characterisation and comparability of biopharmaceutical processes and products. |
| Start Year | 2011 |
| Description | Fujifilm Diosynth Biotechnologies |
| Organisation | Fujifilm |
| Department | Fujifilm Diosynth Biotechnologies |
| Country | United States |
| Sector | Private |
| PI Contribution | Collaborating Organisation and Project Partner. Fujifilm Diosynth Biotechnologies is an industry-leading biologics Contract Manufacturing Organization with locations in Research Triangle Park, North Carolina, USA, and Billingham, UK |
| Start Year | 2011 |
| Description | GE Healthcare |
| Organisation | GE Healthcare Limited |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Collaborating Organisation and Project Partner. GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. |
| Start Year | 2011 |
| Description | Health Protection Agency (HPA) |
| Organisation | Health Protection Agency |
| Country | United Kingdom |
| Sector | Charity/Non Profit |
| PI Contribution | Collaborating Organisation and Project Partner. The Health Protection Agency is an independent UK organisation that was set up by the government in 2003 to protect the public from threats to their health from infectious diseases and environmental hazards. It does this by providing advice and information to the general public, to health professionals such as doctors and nurses, and to national and local government. |
| Start Year | 2011 |
| Description | Health Tech and Medicines KTN |
| Organisation | HealthTech and Medicines Knowledge Transfer Network (Health KTN) |
| Country | United Kingdom |
| Sector | Charity/Non Profit |
| PI Contribution | Collaborating Organisation and Project Partner |
| Start Year | 2011 |
| Description | Lonza Biologics |
| Organisation | Lonza Group |
| Country | Global |
| Sector | Private |
| PI Contribution | Collaborating Organisation and Project Partner. Leading Supplier to the Life-Science Industries. |
| 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 | MedImmune |
| Organisation | AstraZeneca |
| Department | MedImmune |
| Country | United Kingdom |
| Sector | Private |
| PI Contribution | Collaborating Organisation and Project Partner. World's leading biotechnology companies. |
| Start Year | 2011 |
| Description | Merck & Co |
| Organisation | Merck |
| Country | Germany |
| Sector | Private |
| PI Contribution | Collaborating Organisation/Project Partne |
| Start Year | 2011 |
| Description | Novo Nordisk |
| Organisation | Novo Nordisk |
| Department | Novo Nordisk UK Research Foundation |
| Country | United Kingdom |
| Sector | Charity/Non Profit |
| PI Contribution | Collaborating Organisation and Project Partner |
| Start Year | 2011 |
| Description | Novozymes Biopharma |
| Organisation | Novozymes Biopharma UK ltd |
| Country | United Kingdom |
| Sector | Private |
| PI Contribution | Collaborating Organisation and Project Partner. Novozymes is a biotech company with a strong focus on enzyme production. We are committed to changing the very foundations of our industrial system for the better by using industrial biotechnology. |
| Start Year | 2011 |
| Description | PALL Europe |
| Organisation | PALL Europe |
| Country | United Kingdom |
| Sector | Private |
| PI Contribution | Collaborating Organisation and Project Partner |
| Start Year | 2011 |
| Description | Pfizer |
| Organisation | Pfizer Ltd |
| Country | United Kingdom |
| Sector | Private |
| PI Contribution | Collaborating Organisation and Project Partner. Pfizer is a leading pharmaceutical company. |
| Start Year | 2011 |
| Description | Polytherics |
| Organisation | Polytherics |
| Country | United Kingdom |
| Sector | Private |
| PI Contribution | Collaborating Organisation and Project Partner. PolyTherics provides site-specific conjugation technologies and novel polymers to enable the development of better biopharmaceutical products. |
| Start Year | 2011 |
| Description | TAP Biosystems |
| Organisation | TAP Biosystems |
| Country | United Kingdom |
| Sector | Private |
| PI Contribution | Collaborating Organisation and Project Partner. TAP Biosystems (formerly The Automation Partnership) provides innovative automation systems and consumables to improve productivity in life science research, development and production. |
| Start Year | 2011 |
| Description | The BioIndustry Association |
| Organisation | BioIndustry Association |
| Country | United Kingdom |
| Sector | Charity/Non Profit |
| PI Contribution | Collaborating Organisation Partner. The BIA is at the forefront of UK bioscience, serving as its voice, connecting individuals and organisations, from SMEs, including innovative start-ups, to multi-national companies, helping to shape the future of the sector. |
| Start Year | 2011 |
| Description | UCB Pharma |
| Organisation | UCB Pharma |
| Country | United Kingdom |
| Sector | Private |
| PI Contribution | Collaborating Organisation and Project Partner |
| Start Year | 2011 |
| Description | ABB Jürgen Dormann Foundation for Engineering Education |
| Form Of Engagement Activity | A formal working group, expert panel or dialogue |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Undergraduate students |
| Results and Impact | Member of the board of the ABB Jürgen Dormann Foundation for Engineering Education Member of the board of the ABB Jürgen Dormann Foundation for Engineering Education, a Swiss charity that provides scholarships to engineering students in different parts of the world who can prove a high standard of academic achievement and who need financial support to be able to continue their studies.. Awarding Body - ABB Jürgen Dormann Foundation, Name of Scheme - ABB Jürgen Dormann Foundation for Engineering Education. |
| Year(s) Of Engagement Activity | 2008,2009,2010,2011,2012,2013,2014,2015,2016 |
| URL | http://new.abb.com/careers/opportunities/students/juergen-dormann-foundation |
| Description | ABB Jürgen Dormann Foundation for Engineering Education |
| Form Of Engagement Activity | A formal working group, expert panel or dialogue |
| Part Of Official Scheme? | No |
| Primary Audience | Participants in your research or patient groups |
| Results and Impact | Member of the board of the ABB Jürgen Dormann Foundation for Engineering Education Member of the board of the ABB Jürgen Dormann Foundation for Engineering Education, a Swiss charity that provides scholarships to engineering students in different parts of the world who can prove a high standard of academic achievement and who need financial support to be able to continue their studies.. Awarding Body - ABB Jürgen Dormann Foundation, Name of Scheme - ABB Jürgen Dormann Foundation for Engineering Education |
| Year(s) Of Engagement Activity | 2012 |
| 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 | IBLF Industrial Biotechnology Skills Group |
| Form Of Engagement Activity | A formal working group, expert panel or dialogue |
| Part Of Official Scheme? | No |
| Primary Audience | Participants in your research or patient groups |
| Results and Impact | IBLF Industrial Biotechnology Skills Group, Leeds, 27 September 2012.. Awarding Body - IBLF Industrial Biotechnology Skills Group, Name of Scheme - IBLF Industrial Biotechnology Skills Group |
| Year(s) Of Engagement Activity | 2012 |
| 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 |