Hub User Feasibility Studies
The FTHM Hub ran an annual User Feasibility Study (UFS) scheme to enable industry, clinical and sector partners to explore early-stage ideas in collaboration with Hub researchers.
The scheme supported short projects designed to test the applicability of Hub tools, data and methods to real industrial and translational challenges.
The UFS programme is now closed, but the portfolio delivered over 40 completed studies across bioprocessing, advanced therapies, analytics, modelling and policy.
Purpose of the UFS Scheme
The scheme provided partners with:
- A short, focused study carried out by a Hub researcher
- Access to Hub expertise, facilities and decisional tools
- A mechanism to explore feasibility, generate early data or compare technology options
- An opportunity to scope follow-on collaborations
Projects were selected for scientific merit, alignment with Hub themes and potential sector benefit.
Themes and Types of Studies Supported
UFS projects covered a broad range of areas, including:
- Manufacturing challenges for viral vectors, CAR-T, ADCs, mAbs, pDNA and mRNA
- Digital decisional tools, cost modelling and supply chain analysis
- Process sustainability (LCA/PMI)
- Analytical and formulation development
- Cell-free synthesis and continuous bioprocessing
- Regulatory readiness and clinical translation considerations
Examples of Impact
The UFS portfolio contributed to:
- Industrial decision-making, including studies with Ipsen, Pharmaron, Albumedix, Oxford Biomedica and others
- Evidence underpinning national initiatives, such as the £18m Gene Therapy Innovation Hubs
- Sector sustainability benchmarks, adopted by the BIA MAC
- Enhancement of analytical and formulation capability for AAV and other modalities
- Follow-on collaborations and joint PhD programmes, including with Albumedix and Univercells/Donaldson
- Insights referenced in national and global strategy, such as the G7 100 Days Mission and MHRA ATMP framework development
What our partners said
Industry Impact
“The Hub’s decisional tools identified cell-free synthesis strategies with up to 35% cost-of-goods savings, helping prioritise development and informing our investment decisions.”
Director of BioProcess Sciences, Ipsen
“This collaboration has expanded our AAV formulation capabilities and enabled access to high-dose formulations, broadening clinical application across therapeutic areas.”
Senior Technical Specialist, Pharmaron
“The feasibility study strengthened our business case by quantifying cost savings, operational flexibility and environmental benefits of our platform.”
Senior Product Manager, Univercells (now Donaldson)
National Strategy & Policy
“Insights from the Hub were used in the BIA’s case to government for a UK viral vector strategy, ultimately leading to the £18M Gene Therapy Innovation Hubs.”
BIA & Oxford Biomedica
“The Hub’s sustainability analysis produced benchmark LCA data for mAbs, AAV and CAR-T. These findings now inform our national sustainability priorities.”
BIA MAC Sustainability Lead
Technology Innovation
“Alcohol-dehydrated albumin particles showed similar stability to lyophilised material and could be reconstituted rapidly—highlighting a promising, energy-efficient alternative to lyophilisation.”
Chief Technology Officer, Albumedix
Collaborative R&D & Skills
“This high-impact research strengthened our partnership with UCL and contributed to the creation of the £4.5M ABViP doctoral training programme.”
Oxford Biomedica
“The collaboration resulted in joint publications and follow-on work with the Hub spin-out Decisional Point.”
Univercells / Donaldson
Legacy
The outcomes continue to inform industry practice, academic research, and UK strategy for advanced medicines. Several projects led to joint publications, further research funding and expanded collaborations across the Hub network.
The approach established through the UFS scheme is continuing in future activity through UCL’s new Advanced Genomic Therapy Centre.
List of Completed Studies
A full list of the completed UFS projects is provided below. These include studies on viral vector production, continuous processing, supply chain modelling, cell-free synthesis, formulation, sustainability analysis and techno-economic evaluation
| Company Lead(s) & HEI partner | Topic |
|---|---|
| Aglaris University of Manchester | Historical batch analysis and trajectory optimisation for T-cell expansion process control |
| Albumedix University of Nottingham | Formulating recombinant human albumin as nanoparticle scaffolds and assessing the potential for drug delivery |
| Albumedix University of Nottingham | Cell therapy supply chain optimisation: an investigation of the impact of product stability |
| Albumedix University of Nottingham | Innovation in viral vector formulation using recombinant albumin |
| AstraZeneca University College London | Real-time process analysis and control of continuous chromatography |
| BioIndustry Association Oxford Biomedica UCL | Economic analysis to investigate the consequences of switching to scalable GMP processes for viral vectors on drug development lifecycle costs |
| Cancer Research UK UCL | Novel DNA manufacturing platforms for use in targeted therapies |
| Cell & Gene Therapy Catapult Loughborough University | Mechanistic modelling for immunotherapy manufacture |
| Cell and Gene Therapy Catapult University of Manchester, UCL | Development of advanced process control approaches for the improved characterisation and optimisation of iPSC therapy manufacturing processes |
| FujiFilm Diosynth Biotechnologies UCL | Cell-free protein synthesis (CFPS) demonstration and production of industrial relevant products |
| Ipsen UCL | Techno-economic evaluation of a cell-free synthesis (CFS) system for the expression of a recombinant toxin |
| NIBSC UCL | Raman spectroscopy of extracellular vesicles and lentiviral vectors |
| Pharmaron UK UCL | Adeno-associated vector formulation strategies |
| Purolite UCL | Bringing down cost of goods in mAb downstream processing |
| TrakCel Imperial College London | Development of supply chain optimization models for autologous CAR T cells |
| Univercells UCL | Economic evaluation of scalable and adherent cell culture platforms for the manufacture of viral vectors |
| Company Lead(s) & HEI partner | Topic |
|---|---|
| AstraZeneca University College London | Coformulation of mAb combinations and product stability |
| BioPharm Services Loughborough | Application of a Simple Unstructured Kinetic Model to Support T-cell Therapy Manufacture |
| LGC UCL | Characterisation of co-formulated product with mass spectrometry |
| Lonza UCL | Technical evaluation of the Lonza Cocoon platform for non-viral CAR-T production |
| Ovizio Imaging Systems UCL | Holographic imaging and image-based cell profiling for manufacturing of CAR-T cell therapies. |
| Redbud labs UCL | Mixing of immune cells in microfluidic devices |
| Sartorius UCL | Rocking motion perfusion bioreactor evaluation for CAR-T production
|
| Sutro Biopharma UCL | Cell-free protein synthesis experimentation |
| Univercells / VaxHub / Leeds Univ UCL | Cell-free synthesis of Polio vaccines |
