Gastrointestinal bioreactor to evaluate ingestible medicines and inform formulation and manufacture
Lead Research Organisation:
University of Strathclyde
Department Name: Inst of Pharmacy and Biomedical Sci
Abstract
One of the major factors limiting understanding the complex dynamic environment in the gut, is the technical difficulty of accessing or visualising the GI tract. GIBio provides a mechanism to replicate the dynamic environment of the gut without the costs or variability associated with animal or human studies such that the design, development and manufacture of formulated ingested products will be transformed. GIBio underpins the development of robust products by providing clinical quality data early in development to accelerate the translation of healthcare technologies to patients. This gold standard equipment, the only accessible facility in the UK, will reduce the time and costs associated with the design, development and manufacture of new drug products.
Oral administration is the most common drug delivery route. Absorption of a drug from the gut into the bloodstream involves disintegration of the dosage form, dissolution of the drug, and transport across the gut wall. The efficiency of these processes is determined by highly complex and dynamic interactions between the gastrointestinal tract, the dosage form and the drug. This complex interplay determines drug delivery performance and may cause large interindividual variability, but is poorly understood. The fine tuning of the equipment to reproduce the gut in health and disease will ensure that patient centric products are developed to improve therapeutic outcomes.
Furthermore, GIBio will generate new research opportunities in formulated ingested products from the food, including animal feed industries and in the evaluation of ingested sensors and medical devices.
Oral administration is the most common drug delivery route. Absorption of a drug from the gut into the bloodstream involves disintegration of the dosage form, dissolution of the drug, and transport across the gut wall. The efficiency of these processes is determined by highly complex and dynamic interactions between the gastrointestinal tract, the dosage form and the drug. This complex interplay determines drug delivery performance and may cause large interindividual variability, but is poorly understood. The fine tuning of the equipment to reproduce the gut in health and disease will ensure that patient centric products are developed to improve therapeutic outcomes.
Furthermore, GIBio will generate new research opportunities in formulated ingested products from the food, including animal feed industries and in the evaluation of ingested sensors and medical devices.
Organisations
- University of Strathclyde (Lead Research Organisation)
- University of Copenhagen (Collaboration)
- Pfizer Global R & D (Collaboration)
- Novartis (Collaboration)
- MERCK (Collaboration)
- AbbVie Inc (Collaboration)
- AstraZeneca (Collaboration)
- National and Kapodistrian University of Athens (Collaboration)
- Johnson & Johnson (Collaboration)
- Boehringer Ingelheim (Collaboration)
- University of Leuven (Collaboration)
- GlaxoSmithKline (GSK) (Collaboration)
- TIM BV - The TIM Company (Project Partner)
- Centre for Process Innovation CPI (UK) (Project Partner)
- ASTRAZENECA UK LIMITED (Project Partner)
| Description | We have discovered various ways to analyse TIM-1 data. This includes looking at how substances become accessible to the body (bioaccessibility) and examining samples from the digestive system (luminal samples) to compare with real-life biological data. This careful evaluation of interpretation expands the reach of the TIM-1 technology in predicting product performance |
| Exploitation Route | This research is of value to others in the expansion of screening tests to identify superior products and to digitalise predictive biopharmaceutics tools |
| Sectors | Agriculture Food and Drink Healthcare Pharmaceuticals and Medical Biotechnology |
| Description | We have collaborated with Norbrook Laboratories to develop protocols to evaluate the performance of veterinary pharmaceutical products in dogs. This has supported them in selecting optimised product attributes and also reduced the number of animal studies that need to be performed |
| First Year Of Impact | 2025 |
| Sector | Healthcare,Pharmaceuticals and Medical Biotechnology |
| Impact Types | Economic |
| Description | Training provided for CEDAR CDT students |
| Geographic Reach | National |
| Policy Influence Type | Influenced training of practitioners or researchers |
| Description | From Bench to Bioequivalence: In Vitro Mechanistic Understanding of ASD Drug Products in Simulated Gastrointestinal Conditions |
| Amount | $750,000 (USD) |
| Funding ID | 1U01FD008388-01 |
| Organisation | Food and Drug Administration (FDA) |
| Sector | Public |
| Country | United States |
| Start | 12/2024 |
| End | 11/2027 |
| Description | Revolutionising relative bioavailability testing: Using AI-PAT to Eliminate Animal Models |
| Amount | £184,526 (GBP) |
| Funding ID | APP49139 |
| Organisation | National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs) |
| Sector | Public |
| Country | United Kingdom |
| Start | 09/2024 |
| End | 03/2025 |
| Description | Membership of INFOGEST group |
| Organisation | AbbVie Inc |
| Department | AbbVie, Germany |
| Country | Germany |
| Sector | Private |
| PI Contribution | The infogest network are working collaboratively to develop a ring study for models of digestion We are performing the relevant studies using the GIBio apparatus to provide data and also leading on a publication that will result from this work |
| Collaborator Contribution | The partners are generating parallel data on alternative models of digestion for hte ring study and also contributing towards the final paper |
| Impact | No outputs yet |
| Start Year | 2023 |
| Description | Membership of INFOGEST group |
| Organisation | Merck |
| Country | Germany |
| Sector | Private |
| PI Contribution | The infogest network are working collaboratively to develop a ring study for models of digestion We are performing the relevant studies using the GIBio apparatus to provide data and also leading on a publication that will result from this work |
| Collaborator Contribution | The partners are generating parallel data on alternative models of digestion for hte ring study and also contributing towards the final paper |
| Impact | No outputs yet |
| Start Year | 2023 |
| Description | Membership of INFOGEST group |
| Organisation | National and Kapodistrian University of Athens |
| Country | Greece |
| Sector | Academic/University |
| PI Contribution | The infogest network are working collaboratively to develop a ring study for models of digestion We are performing the relevant studies using the GIBio apparatus to provide data and also leading on a publication that will result from this work |
| Collaborator Contribution | The partners are generating parallel data on alternative models of digestion for hte ring study and also contributing towards the final paper |
| Impact | No outputs yet |
| Start Year | 2023 |
| Description | Membership of INFOGEST group |
| Organisation | Novartis |
| Country | Global |
| Sector | Private |
| PI Contribution | The infogest network are working collaboratively to develop a ring study for models of digestion We are performing the relevant studies using the GIBio apparatus to provide data and also leading on a publication that will result from this work |
| Collaborator Contribution | The partners are generating parallel data on alternative models of digestion for hte ring study and also contributing towards the final paper |
| Impact | No outputs yet |
| Start Year | 2023 |
| Description | Membership of INFOGEST group |
| Organisation | University of Copenhagen |
| Country | Denmark |
| Sector | Academic/University |
| PI Contribution | The infogest network are working collaboratively to develop a ring study for models of digestion We are performing the relevant studies using the GIBio apparatus to provide data and also leading on a publication that will result from this work |
| Collaborator Contribution | The partners are generating parallel data on alternative models of digestion for hte ring study and also contributing towards the final paper |
| Impact | No outputs yet |
| Start Year | 2023 |
| Description | Membership of INFOGEST group |
| Organisation | University of Leuven |
| Country | Belgium |
| Sector | Academic/University |
| PI Contribution | The infogest network are working collaboratively to develop a ring study for models of digestion We are performing the relevant studies using the GIBio apparatus to provide data and also leading on a publication that will result from this work |
| Collaborator Contribution | The partners are generating parallel data on alternative models of digestion for hte ring study and also contributing towards the final paper |
| Impact | No outputs yet |
| Start Year | 2023 |
| Description | Membership of TIM User Group |
| Organisation | AbbVie Inc |
| Department | AbbVie, Germany |
| Country | Germany |
| Sector | Private |
| PI Contribution | We have supported ongoing efforts to write a white paper and also chaired meetings for the wider team |
| Collaborator Contribution | AstraZeneca have hosted Eleanor Jones for additional training at their site for a period of 2 days to further enhance understanding and to drive towards a longer term collaboration Members of the AZ team also spend 2 days at our facility to further support training and use of the equipment |
| Impact | Current outputs are training records but a white paper is imminent |
| Start Year | 2023 |
| Description | Membership of TIM User Group |
| Organisation | AstraZeneca |
| Department | Research and Development AstraZeneca |
| Country | United Kingdom |
| Sector | Private |
| PI Contribution | We have supported ongoing efforts to write a white paper and also chaired meetings for the wider team |
| Collaborator Contribution | AstraZeneca have hosted Eleanor Jones for additional training at their site for a period of 2 days to further enhance understanding and to drive towards a longer term collaboration Members of the AZ team also spend 2 days at our facility to further support training and use of the equipment |
| Impact | Current outputs are training records but a white paper is imminent |
| Start Year | 2023 |
| Description | Membership of TIM User Group |
| Organisation | Boehringer Ingelheim |
| Country | Germany |
| Sector | Private |
| PI Contribution | We have supported ongoing efforts to write a white paper and also chaired meetings for the wider team |
| Collaborator Contribution | AstraZeneca have hosted Eleanor Jones for additional training at their site for a period of 2 days to further enhance understanding and to drive towards a longer term collaboration Members of the AZ team also spend 2 days at our facility to further support training and use of the equipment |
| Impact | Current outputs are training records but a white paper is imminent |
| Start Year | 2023 |
| Description | Membership of TIM User Group |
| Organisation | GlaxoSmithKline (GSK) |
| Department | Research and Development GSK |
| Country | United Kingdom |
| Sector | Private |
| PI Contribution | We have supported ongoing efforts to write a white paper and also chaired meetings for the wider team |
| Collaborator Contribution | AstraZeneca have hosted Eleanor Jones for additional training at their site for a period of 2 days to further enhance understanding and to drive towards a longer term collaboration Members of the AZ team also spend 2 days at our facility to further support training and use of the equipment |
| Impact | Current outputs are training records but a white paper is imminent |
| Start Year | 2023 |
| Description | Membership of TIM User Group |
| Organisation | Johnson & Johnson |
| Department | Janssen Pharmaceutica NV |
| Country | Belgium |
| Sector | Private |
| PI Contribution | We have supported ongoing efforts to write a white paper and also chaired meetings for the wider team |
| Collaborator Contribution | AstraZeneca have hosted Eleanor Jones for additional training at their site for a period of 2 days to further enhance understanding and to drive towards a longer term collaboration Members of the AZ team also spend 2 days at our facility to further support training and use of the equipment |
| Impact | Current outputs are training records but a white paper is imminent |
| Start Year | 2023 |
| Description | Membership of TIM User Group |
| Organisation | Pfizer Global R & D |
| Country | United States |
| Sector | Private |
| PI Contribution | We have supported ongoing efforts to write a white paper and also chaired meetings for the wider team |
| Collaborator Contribution | AstraZeneca have hosted Eleanor Jones for additional training at their site for a period of 2 days to further enhance understanding and to drive towards a longer term collaboration Members of the AZ team also spend 2 days at our facility to further support training and use of the equipment |
| Impact | Current outputs are training records but a white paper is imminent |
| Start Year | 2023 |
| Description | CMAC Open day 2023 |
| Form Of Engagement Activity | Participation in an open day or visit at my research institution |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Industry/Business |
| Results and Impact | The CMAC open day welcomed 288 delegates from 68 companies as well as many academics to the event Following the event there have been follow up activities from Blazemetrics about involvement in a project Plus we have been approached by academics to use the GIBio facility for their own research. |
| Year(s) Of Engagement Activity | 2023 |
| URL | https://cmac.ac.uk/open-days-2023 |
| Description | CMAC Townhall 2024 |
| 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 | Industry/Business |
| Results and Impact | GI Bio presented a short session to 8 groups, each consisting of approximately 10-20 people, to highlight the research conducted at the GI Bio Facility. Eleanor Jones delivered an interactive poster presentation, supplemented with additional information slides about GI Bio, the TIM systems, and the importance of understanding drug performance under biorelevant and dynamic conditions using TIM-1 and TIM-2. The capabilities and future aims of the facility were discussed. The event sparked significant interest, with discussions about showcasing the facility at the next University Convenor Court. Positive feedback was received from participants via email, noting how informative and engaging the presentation was. |
| Year(s) Of Engagement Activity | 2024 |
| Description | Explorathon @ The Riverside Museum 2024 |
| Form Of Engagement Activity | Participation in an activity, workshop or similar |
| Part Of Official Scheme? | No |
| Geographic Reach | Regional |
| Primary Audience | Public/other audiences |
| Results and Impact | During Explorathon, we engaged with the general public, particularly school-age children, to showcase research in Biopharmaceutics and Pharmaceutical Formulation. The session demonstrated how drug substances are transformed into products for patients, using 3D-printed formulations in various colours, shapes, and sizes. We played an interactive 'guess who' game, highlighting different solid oral dosage forms and discussing the importance of tailoring these for patient use. We also used a knitted model gut to explain our research with The TIM systems, illustrating the role of the gastrointestinal system in processing oral solid dosage forms. By focusing on paediatric medicines, we aimed to educate both children and their parents/guardians, fostering a greater understanding of how pharmaceutical research impacts everyday healthcare. |
| Year(s) Of Engagement Activity | 2024 |
| URL | https://www.explorathon.co.uk/ |
| Description | GIBio open day for CMAC researchers |
| Form Of Engagement Activity | Participation in an open day or visit at my research institution |
| Part Of Official Scheme? | No |
| Geographic Reach | Local |
| Primary Audience | Postgraduate students |
| Results and Impact | This open event was offered as an opportunity for those working at CMAC https://cmac.ac.uk/ to learn more about the GIBio facility and how it may be useful for their own research |
| Year(s) Of Engagement Activity | 2024 |
| Description | GIBio open event for University research management |
| Form Of Engagement Activity | Participation in an open day or visit at my research institution |
| Part Of Official Scheme? | No |
| Geographic Reach | Local |
| Primary Audience | Other audiences |
| Results and Impact | We held an open event for the research and knowledge exchange team at the University of Strathclyde. This event aimed to showcase the research at the University to those who facilitate our endeavours via contracts; funding support and other professional research support activities. This event helped them to understand our work and contextualise this in relation to their own jobs. They also oversea research across the University and are ideally placed to make connections where they see opportunities for collaborative research |
| Year(s) Of Engagement Activity | 2024 |
| Description | Hosted a group of PhD students from CEDAR, an EPSRC funded CDT |
| 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 | Postgraduate students |
| Results and Impact | 18 PhD students attended a session to learn more about the GIBio facility and how this may be useful for them in their own PhD studies. |
| Year(s) Of Engagement Activity | 2025 |
| Description | Hosted an International Team from University of Western Cape South Africa |
| Form Of Engagement Activity | Participation in an open day or visit at my research institution |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Other audiences |
| Results and Impact | A team from the University of Western Cape in South Africa visited the facility to learn about our work in reducing animal experiments and to consider future collaborative activity |
| Year(s) Of Engagement Activity | 2024 |
| Description | Keynote Presentation given at University of Strathclyde 3Rs & Culture of Care Day - 4th December 2024 |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Third sector organisations |
| Results and Impact | A presentation was provided at the University of Strathclyde 3Rs & Culture of Care Day - 4th December 2024 This was an event for both industrial and academic researchers interested in the 3Rs The audience was approximately 150 individuals |
| Year(s) Of Engagement Activity | 2024 |
| Description | Reciprocal visit with academics from Scotland's Rural College (SRUC) |
| 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 | We have reciprocal visits from academics from SRUC. We discussed the value of GIBio for veterinary research and understanding both drug absorption and nutrition in monogastric species The output of this event was a series of proposed collaborative project ideas and we are actively seeking funding to pursue these ideas |
| Year(s) Of Engagement Activity | 2024 |
| Description | SIPBS Biopharmaceutics Group tour of GIBio |
| 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 | The SIPBS Biopharmaceutics group members received an invitation to visit the GIBio facility to see the artificial intestines for the first time. During their visit, TIM-1 and TIM-2 were set up to conduct an experiment showcasing the peristaltic movements and how samples are taken from TIM-1. Eleanor Jones and Hannah Batchelor explained their functions and use to the group, generating much interest in how they replicate the human gastrointestinal system. Additional members of staff from the Strathclyde Institute of Pharmacy and Biomedical Sciences attended the event to see how the new equipment could benefit their own research. After the tour, Hannah Batchelor gave a presentation about the role of GIBio in the Continuous Manufacturing and Crystallisation department (CMAC). This was followed by a cake and craft session where attendees produced posters related to gastrointestinal topics for the GIBio Facility. |
| Year(s) Of Engagement Activity | 2023 |
| Description | SIPBS Open Day - 2024 |
| Form Of Engagement Activity | Participation in an open day or visit at my research institution |
| Part Of Official Scheme? | No |
| Geographic Reach | Local |
| Primary Audience | Public/other audiences |
| Results and Impact | Strathclyde Institute of Pharmacy & Biomedical Sciences opened its doors to showcase how our cutting-edge research enables a deeper understanding of disease to design new medicines and improve patient outcomes. Eleanor Jones participated in the outreach event, representing the GIBio Facility. Activities included a pharmaceutical formulation themed guess who game, displays containing 3D-pritnted tablets to highlight the many forms of the oral dosage form available for patient use and discussions about the human gastrointestinal system. A poster was displayed to promote discussion on the capabilities of the GIBio Facility and how we are working towards replacing animal studies in the early stages of drug development. |
| Year(s) Of Engagement Activity | 2024 |
| URL | https://www.gla.ac.uk/events/sciencefestival/ |
| Description | Visit from Mark McAllister, Chief Scientific Officer of Biowaived Ltd |
| 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 | Industry/Business |
| Results and Impact | Biowaived mission is delivering biopharmaceutics and dissolution strategies for pharmaceutical and biotechnology companies to support drug product development. Mark visited the facility to learn more about collaborative opportunities for GiBIo and how we can work together in the future. |
| Year(s) Of Engagement Activity | 2025 |
| Description | Visit from industry representative from Almac (Terry Ernest) |
| Form Of Engagement Activity | Participation in an open day or visit at my research institution |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Industry/Business |
| Results and Impact | Almac Group deliver expertise right across the drug development lifecycle and were keen to visit the GIBio facility to understand more about how they can collaborate with us to support pharmaceutical product development. The initial visit was from one senior individual but follow up visits are planned |
| Year(s) Of Engagement Activity | 2024 |
| Description | Visit to facility from Dr Kofi Asare-Addo (University of Huddersfield) |
| 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 | Professional Practitioners |
| Results and Impact | Kofi visited the facility to learn more about functionality and how he could integrate work at GIBio with his own research aspirations We are already planning future collaborative research activities |
| Year(s) Of Engagement Activity | 2025 |