Development of an on-demand sensor and monitoring technology based on switchable nanobodies for cell therapy bioprocessing
Lead Research Organisation:
University of Birmingham
Department Name: Chemical Engineering
Abstract
Cell therapies, which use human cells to restore, maintain, or improve the functioning of human tissues or organs, hold enormous potential for the treatment of a wide range of diseases and conditions, including a variety of cancers. While cell therapies have the potential to improve healthcare for millions of patients worldwide, manufacturing remains a major hurdle for clinical translation. Today's cell therapies manufacturing processes, which include the use of patient's own cells or donor cells to manufacture the therapeutic product, involve manual, labour-intensive and open processes that require highly-skilled personnel. This in turn leads to high process variability, risk of contamination and high manufacturing costs, all of which are major obstacles for cell therapies to realise their full potential and bring about widespread access to the global patient population. New technologies are urgently needed to develop reliable and robust manufacturing processes that ensure quality and consistency of cell therapy products at an economically viable cost.
This project will develop an on-demand sensor and monitoring technology that will enable, for the first time, real-time, non-disruptive measurement of key biochemicals in cell culture media. These unprecedented capabilities will be enabled by an innovative microfluidic sensing platform comprising smart, switchable electrode-tethered nanobodies. In contrast with conventional offline analysis, the acquisition of real-time process data will allow immediate response to process variations, thus providing a fine level of process control. This is essential for the consistent production of high-quality therapeutic cells in high yields, independently of the patient's or donor's cells. It will provide an exceptional opportunity to implement fully automated, robust cell therapy culture processes and bring down production costs, ultimately delivering cost-effective and impactful therapeutics to patients in need.
This project will develop an on-demand sensor and monitoring technology that will enable, for the first time, real-time, non-disruptive measurement of key biochemicals in cell culture media. These unprecedented capabilities will be enabled by an innovative microfluidic sensing platform comprising smart, switchable electrode-tethered nanobodies. In contrast with conventional offline analysis, the acquisition of real-time process data will allow immediate response to process variations, thus providing a fine level of process control. This is essential for the consistent production of high-quality therapeutic cells in high yields, independently of the patient's or donor's cells. It will provide an exceptional opportunity to implement fully automated, robust cell therapy culture processes and bring down production costs, ultimately delivering cost-effective and impactful therapeutics to patients in need.
People |
ORCID iD |
Paula Mendes (Principal Investigator) |
Publications
Carroll D
(2023)
Recent advances in surface modification and antifouling strategies for electrochemical sensing in complex biofluids
in Current Opinion in Electrochemistry
Description | The field of cell therapy is rapidly progressing, bringing new hope to patients in a wide range of diseases. However, the manufacture of these therapies remains a major barrier to meeting increased market demand and patient access. New technologies are needed to implement integrated process analytics, enabling real-time monitoring of process parameters and critical quality attributes of cell therapies during biomanufacture. The incorporation of biosensors into bioreactor systems would allow for fast, non-destructive sensing to achieve in-process monitoring of cell products within closed systems. This project addressed that need and has developed an electrochemical nanobody-based biosensor capable of sensing cell-specific proteins that will better inform cell culture processes. Furthermore, this sensing device incorporates switchable surface technology, enabling ON/ OFF electrical control of antigen- nanobody binding to achieve real-time, on-demand sensing of analytes. Thus, providing the capability to achieve in-process monitoring of cell products within closed systems. |
Exploitation Route | Following demonstration of the technology, we will explore it for licencing. |
Sectors | Healthcare |
Description | Prostate Cancer UK: From Ideas to Innovation (Member of Scientific Organising Committee), London, UK. |
Geographic Reach | Multiple continents/international |
Policy Influence Type | Participation in a guidance/advisory committee |
Impact | It will enable to accelerate the impact of research in Prostate Cancer, ensuring the results of the scientific community hard work have the best chance of benefiting the lives of those affected by prostate cancer. |
URL | https://prostatecanceruk.org/research/for-researchers/from-ideas-to-innovation |
Description | Collaboration with Imec, Belgium |
Organisation | Interuniversity Micro-Electronics Centre |
Country | Belgium |
Sector | Academic/University |
PI Contribution | PhD student from Imec, Belgium is visiting Mendes group for 6 months to collaborate and explore the technology together. |
Collaborator Contribution | PhD student fully funded working in Mendes lab for 6 months. |
Impact | It started in February 2023 and the aim is to get a publication together and further exploitation of the technology. |
Start Year | 2023 |
Title | STIMULI-RESPONSIVE SURFACES |
Description | A stimuli-responsive surface (3) comprising a substrate (20) on which is located a switchable molecule (2) which has a functional moiety (22) associated therewith, wherein the switchable molecule (2) has a first equilibrium state (2A) in which access to the functional moiety (22) is inhibited and a second stimulated state (2B), in which access to the functional moiety (22) is permitted. |
IP Reference | WO2018185503 |
Protection | Patent / Patent application |
Year Protection Granted | 2018 |
Licensed | No |
Impact | The patent is still pending in Europe and US but we are creatign data that we aim at providing the proof of concept for it to be licenced. |
Description | Facebook Live Q&A |
Form Of Engagement Activity | Engagement focused website, blog or social media channel |
Part Of Official Scheme? | No |
Geographic Reach | National |
Primary Audience | Public/other audiences |
Results and Impact | Facebook Live Q&A with Prostate Cancer UK supporters during the Women and Girls in STEM day It allowed to explain how nanotechnology can be used to develop better sensors. The audience was very grateful and appreciated all the efforts we scientist are doing to enhance healthcare delivery. |
Year(s) Of Engagement Activity | 2022 |
Description | Science Museum exhibition on "Cancer Revolution: Science, innovation and hope " |
Form Of Engagement Activity | Participation in an activity, workshop or similar |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Public/other audiences |
Results and Impact | 2021-2023 on Science Museum exhibition on "Cancer Revolution: Science, innovation and hope ", Oct 2021-March 2022 Manchester Science and Industry Museum; May 2022-Jan 2023 - London Science Museum. It provides awareness on how technology has been developed to improve quality of life and save lives. |
Year(s) Of Engagement Activity | 2021,2022,2023 |
Description | Visit: Peter Kyle, Shadow Secretary for DSIT, Richard Parker, Labour Candididate for West Midlands Mayor |
Form Of Engagement Activity | Participation in an open day or visit at my research institution |
Part Of Official Scheme? | No |
Geographic Reach | National |
Primary Audience | Policymakers/politicians |
Results and Impact | Peter Kyle, Shadow Secretary for DSIT, Richard Parker, Labour Candidate for West Midlands Mayor have visited the Healthcare Technologies Institute at University of Birmingham and I spoke about the technology we develop in the group and how it will impact in peoples lives. Fund from UK government and Cancer UK was highlighted. |
Year(s) Of Engagement Activity | 2024 |