Commercial opportunities for an automated extracellular vesicle biofoundry
Lead Research Organisation:
Imperial College London
Department Name: Dept of Medicine
Abstract
Our cells produce and secret tiny extracellular vesicles, called exosomes which are essentially molecular messages that cells send to each other. Exosomes are composed of many different molecular components, including proteins, that are encased in a lipd (fat) bilayer. Exosomes help to keep us healthy and have many different roles in the body. Ongoing research has also shown that exosomes could potentially be used as therapies to treat diseases including cancers. Unfortunately, there are limitations with current exosome manufacturing methods which are making it difficult to produce enough exosomes for larger studies. Essentially, it is difficult to generate enough exosomes to begin the larger scale experiments and clinical trials needed to safely test and develop exosomes. For several years we have been developing new methods to manufacture therapeutic exosomes. However, we are still at a relatively early stage of development. With additional support we reach a stage of development where we can more easily collaborate with pharmaceutical companies to accelerate this promising new therapeutic class.
Organisations
People |
ORCID iD |
| Paul Freemont (Principal Investigator) |
Publications
Kelwick R
(2024)
Accelerating extracellular vesicle research and biotechnological applications using synthetic biology approaches
in Extracellular Vesicle
Kelwick R
(2021)
AL-PHA beads: Bioplastic-based protease biosensors for global health applications
in Materials Today
Kelwick RJR
(2023)
Opportunities to accelerate extracellular vesicle research with cell-free synthetic biology.
in Journal of extracellular biology
Kelwick RJR
(2020)
Biological Materials: The Next Frontier for Cell-Free Synthetic Biology.
in Frontiers in bioengineering and biotechnology
| Description | Our cells produce and secrete tiny extracellular vesicles, called exosomes which are essentially molecular messages that cells send to each other. Exosomes are composed of many different molecular components, including proteins, that are encased in a lipd (fat) bilayer. Exosomes help to keep us healthy and have many different roles in the body. Ongoing research has also shown that exosomes could potentially be used as therapies to treat diseases including cancers. Unfortunately, there are limitations with current exosome manufacturing methods which are making it difficult to produce enough exosomes for larger studies. Essentially, it is difficult to generate enough exosomes to begin the much larger scale experiments and clinical trials needed to safely test and develop exosome therapeutics. Our project enabled us to continue development of large-scale exosome manufacturing methods and an exosome isolation technology, based upon functionalised bacterial-manufactured biological materials, which is now at the PCT patent application stage (PCT/GB2020/052302). Our award also enabled us to adapt aspects of our exosome isolation technology to create functional biological materials that enable the detection of EV-associated proteolytic activities that could serve as important human disease biomarkers. |
| Exploitation Route | We have several manuscripts in development which will allow us to further disseminate research data and ideas to the international synthetic biology and EV research communities relating to our continuum of work on EV engineering and manufacturing. We anticipate that our manuscripts will lead to future innovative foundational or application driven EV research. Including a continuation of our our EV research. >Kelwick, Webb etal., 'Opportunities to accelerate extracellular vesicle research with cell-free synthetic biology' perspective research article (i.e. contains research data) currently in peer review at The Journal of Extracellular Biology. Kelwick, Webb and Freemont, 'Opportunities for engineering outer membrane vesicles using synthetic biology approaches', opinion manuscript in preparation. We anticipate academic-industry engagements as a direct consequence of this grant, our previous EV engineering/manufacturing pathfinder grant and our most recent engineering biology breakthrough award (all BBSRC). Specifically: >Sumitomo Pharma reached out to the Industry Partnerships and Commercialisation Team in Imperial's Enterprise Division in Jan 2023 expressing their interest in our cell-free EV engineering work and we will begin to explore potential collaborative opportunities in the very near future. >A US biotechnology company, Edge Foods, is also interested in our EV manufacturing/engineering work and is in the process of signing an Imperial CDA so that we can continue discussions on potential collaborative opportunities. >Fujifilm Nordic AB is also interested in our EV manufacturing/engineering work and is in the process of signing an Imperial CDA so that we can discuss potential collaborative opportunities and the possibility of licensing previously developed exosome isolation IP (Imperial managed and at PCT stage PCT/GB2020/052302). Insights from this grant have also enabled us to develop pilot data for a new outer membrane vesicle (OMV) engineering project in which we envision therapeutic applications for bacterial vesicles. This has led us to a successful Future Biomanufacturing Research Hub (BRH) Award valued at £25,304 (DI costs at full FEC) entitled "OMEGA: Outer Membrane Vesicle Engineering and Manufacturing". Our award fits within the larger EPSRC grant EP/S01778X/1 which was awarded to The University of Manchester in 2019. We anticipate that novel EV/OMV engineering and manufacturing methods will be developed through a continuum of work across this FoF grant, our recent engineering biology breakthrough grant and our new Future BRH award that may be patentable. We will fully disclose these developments with Imperial Enterprise (our TTO) as appropriate. Dr Kelwick also continues his discussions on a potential Imperial spin out that may make use of existing exosome isolation isolation IP (PCT/GB2020/052302) and/or any newly developed IP that may emerge through a continuum of this FoF grant and the subsequent EV/OMV manufacturing grants (i.e. BB/W012987/1 and the Future BRH award [part of EPSRC EP/S01778X/1]. |
| Sectors | Agriculture Food and Drink Manufacturing including Industrial Biotechology Pharmaceuticals and Medical Biotechnology |
| URL | https://www.imperial.ac.uk/news/218253/low-cost-disease-detecting-biosensors-show-global-health/ |
| Description | We anticipate academic-industry engagements as a direct consequence of this grant specifically: >Sumitomo Pharma reached out to the Industry Partnerships and Commercialisation Team in Imperial's Enterprise Division in Jan 2023 expressing their interest in our cell-free EV engineering work and we will begin to explore potential collaborative opportunities in the very near future. >A US biotechnology company, Edge Foods, is also interested in our EV manufacturing/engineering work and is in the process of signing an Imperial CDA so that we can continue discussions on potential collaborative opportunities. >Fujifilm Nordic AB is also interested in our EV manufacturing/engineering work and is in the process of signing an Imperial CDA so that we can discuss potential collaborative opportunities and the possibility of licensing previously developed exosome isolation IP (Imperial managed and at PCT stage PCT/GB2020/052302). |
| First Year Of Impact | 2023 |
| Sector | Agriculture, Food and Drink,Manufacturing, including Industrial Biotechology,Pharmaceuticals and Medical Biotechnology |
| Impact Types | Economic |
| Description | 21ENGBIO PROJECT ECHO: Modular exosome prototyping & engineering |
| Amount | £100,695 (GBP) |
| Funding ID | BB/W012987/1 |
| Organisation | Biotechnology and Biological Sciences Research Council (BBSRC) |
| Sector | Public |
| Country | United Kingdom |
| Start | 01/2022 |
| End | 10/2022 |
| Description | Future Biomanufacturing Research Hub |
| Amount | £10,668,316 (GBP) |
| Funding ID | EP/S01778X/1 |
| Organisation | Engineering and Physical Sciences Research Council (EPSRC) |
| Sector | Public |
| Country | United Kingdom |
| Start | 03/2019 |
| End | 03/2026 |
| Description | Proof of Concept (PoC) Project Programme |
| Amount | £3,000,000 (GBP) |
| Funding ID | EP/Z533142/1 |
| Organisation | Engineering and Physical Sciences Research Council (EPSRC) |
| Sector | Public |
| Country | United Kingdom |
| Start | 05/2024 |
| End | 05/2026 |
| Title | METHOD FOR ISOLATING EXTRACELLULAR VESICLES |
| Description | The present invention provides a gentle and low cost means to isolate extracellular vesicles, including exosomes, from a surrounding sample. In particular the invention relates to the use of a fusion protein and biopolymer beads in such methods. Methods, compositions and medical uses of such compositions are also provided. |
| IP Reference | US2022356269 |
| Protection | Patent / Patent application |
| Year Protection Granted | 2022 |
| Licensed | No |
| Impact | Patent asset: Method for isolating extracellular vesicles; GB priority patent filing completed on 24/09/19, entering PCT Stage 23/09/20 (PCT/GB2020/052302/ WO2021058950A1). National entry and substantive examination pursued in EPO (EP4034646A1), USPTO (US20220356269A1), APO (AU2020354608A1). Know-how and expertise: Regarding manufacturing and engineering of PHA-based biopolymer particles and EV applications. Consultancy projects can be arranged, via ICON, to facilitate pilot testing of the technology prior to licensing, custom biopolymer functionalisation or bespoke application development towards client specific requirements. Ongoing licensing discussions with several companies. |
| Description | Chaired conference session and led panel discussion at Precision EV Forum Cambridge 2024 |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | Dr Richard Kelwick attended, chaired a conference session "Molecular Mechanisms, EV-Engineering and Therapeutic Delivery" and led a panel discussion "What are the pivotal challenges and emerging innovations shaping the future of extracellular vesicle-based therapeutics and vaccines?" at Precision EV Forum Cambridge 23rd-24th October 2024. Academic, clinical, industry and medical regulatory participants were in attendance. Networking has led to new collaborations and opportunities (e.g., ONI supporting our BBSRC FoF application, Beckman enabling nano flow equipment demo and important discussions with industry/regulatory experts on clinical bacterial vesicle development and commercialisation). |
| Year(s) Of Engagement Activity | 2024 |
| URL | https://www.precisionmedicineforum.com/extracellular-vesicles-2024/agenda/ |
| Description | EV/nano-flow cytometry presentation at Department of Infectious Disease (DoID) Early Career Researchers day |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | Local |
| Primary Audience | Other audiences |
| Results and Impact | Around 50 postgraduate students/postdoctoral researchers attended (in person or digitally) the Department of Infectious Disease Early Career Researchers Day 2022. I (Dr Kelwick) presented our research on cell-free EV engineering and characterisation using nano flow cytometry. This sparked useful discussions around EV engineering and analyses. |
| Year(s) Of Engagement Activity | 2022 |
| URL | https://www.eventbrite.co.uk/e/department-of-infectious-disease-early-career-researchers-day-2022-ti... |
| Description | Invited speaker at cell-free specialist working group as part of UCL's Future Targeted Healthcare Manufacturing Hub |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | Regional |
| Primary Audience | Professional Practitioners |
| Results and Impact | Dr Kelwick (research associate Prof. Freemont group) was invited to present a talk entitled cell-free strategies for engineering extracellular vesicles as part of an meeting organised by the cell-free specialist working group as part of the Future Targeted Healthcare Manufacturing Hub at UCL. I presented on May 19th 2023 to an audience of academic researchers, students and industry professionals. |
| Year(s) Of Engagement Activity | 2023 |
| Description | Participation in an activity, workshop or similar - Oral presentation at UKEV & GSEV Autumn 2nd-3rd Sept 2020 |
| 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 | Dr Kelwick was invited to give an online oral presentation on our research at UKEV & GSEV Joint Autumn Meeting in Saarbru¨cken, Saarland University 2nd-3rd Sept 2020. The online talk was entitled "AL-PHA beads: engineered biomaterials for detecting extracellular vesicle-associated metalloproteinase biosensors." |
| Year(s) Of Engagement Activity | 2020 |
| URL | https://www.ukev.org.uk/the-2020-gsev-autumn-symposium-will-be-jointly-organised-with-ukev/ |