MICA Biosystems is leading an exciting project to improve the traditional static Caco-2 assay, a key method for testing how drugs are absorbed in the body. We are introducing magnetic nanoparticles to make this test more dynamic, simulating the natural movements in the human gut. This innovation is important for the pharmaceutical industry because it bridges the gap between tests and actual human drug absorption rates. An externally controlled magnetic field interacts with magnetic nanoparticles attached to the cell membrane, inducing deformations that simulate the dynamic cellular environment, akin to gastrointestinal motility. Early results show our technology improves the accuracy of these tests; this project aims to perform more tests to validate these results with more trials. Additionally, we will develop mathematical models to predict drug absorption more accurately. The impact of this project goes beyond the immediate drug testing. It helps reduce the time and cost of drug development, bringing effective treatments to market faster and improving global healthcare. This project fosters collaboration between the Newton Gateway and MICA Biosystems. The Newton Gateway works as a delivery partner to facilitate mathematical knowledge exchange, translation and dissemination. Together this project will promote magnetic nanotechnology and biotechnology innovation. The knowledge gained can lead to new biotechnological advancements, jobs and opportunities in the UK and beyond. By setting a new standard in drug testing, MICA Biosystems aims to boost the UK's role in pharmaceutical and biotechnological innovation, contributing to the country's economic growth and enhancing its appeal as a scientific research and development hub.

Low back (LBP) pain and Chronic Low Back Pain (CLBP) represent a common condition linked to musculoskeletal diseases, which affect aged population and represent a major social and economic problem in developed countries. LBP is more common among people aged 40--80 years. The overall number of individuals affected is expected to increase as the population ages. Globally, about 40% of people have LBP at some point in their lives, with estimates as high as 80% of people affected in the developed world. LBP and CLBP in adults doubled in the last decade, continue to increase dramatically in the aging population, with a significant impact on functional ability resulting in significant pain, disability, restriction of activities such as sport, and an inability to work. Economic burden owing to the management of these conditions is significant. Spinal fusion is a surgical procedure to treat these disease conditions and spinal instability. When physiotherapy and conservative approaches fail, the pain and quality of life of patient can be significantly worsened. Fusion involves surgically joining two or more vertebrae through instrumentation and bone grafts, reducing the normal mobility of the spine which may help patients to feel better and may improve their quality of life. The current gold standard treatment uses sources of healthy bone from other regions of the patient, but this procedure holds several drawbacks: increased surgical time, greater costs, donor-site post-operative pain and morbidity, and limited availability of patient's bone especially for long spinal segment fusions. Over the years, donor bone and types of artificial biomaterials including metallic, ceramic, and polymers have been used clinically to improve vertebral fusion, offering mechanical stability. However, they lack the bone forming properties of the patients' own bone. Moreover, in patients suffering from osteoporosis, these implants are problematic to be implanted with sufficient stability. The gold standard graft to accelerate bone fusion currently still remains the commercial sources or autologous bone graft harvested from the hip or collected during the operation with issues of low levels of long term successful outcomes. We have developed an innovative approach which can provide potential solutions for spinal repair with enhanced successful outcomes. Using a patented and novel biomagnetic cell based approach, we can control the way bone forms in the spine enabling precise and increased bone formation for fusion of the spine. This Innovate program will enable us to test the feasibility of our therapy for spinal applications.

The Caco-2 cell line used by the pharmaceutical industry and support companies is the gold standard for the prediction of drug absorption and permeability in vitro by mimicking the small intestine. However, this model lacks the dynamic motion which represents one of the physiological functions of the small intestine (peristalsis). Our new product developments using MICA technology investigate the possibility of improving the static Caco-2 cell model by creating a dynamic in vitro screening environment. Our results to dateas part of an Innovate funded Feasibility study have shown that MICA’ technology improves the absorption of the selected drugs, and their permeability is more similar to that found in the human intestine. Our data suggests that MICA’ technology applied to Caco-2 drug permeability assay could be used to a better predict, using in vitro assays, the in vivo human drug absorption rates. We are now at the stage of validation of our assay with a partner ADME contract research organisation (CRO) before commercialisation of our product. This project will enable us to create the final QA steps and the validation of the assay in an ADME CRO environment using validated drug compounds. The final stages will include creation of standard operating procedures (SOPs) alligned to the existing assay and design of new QA steps for the protocol.

The Caco-2 cell line is the gold standard for the prediction of drug absorption and permeability in vitro by mimicking the small intestine. However, this model lacks the dynamic motion which represents one of the physiological functions of the small intestine (peristalsis). In our research, we investigate the possibility the similarity between the static Caco-2 cell model and the dynamic intestine by creating a dynamic in vitro environment using MICA technology. Our results to date have shown that MICA’ technology improves the absorption of the selected drugs, and their permeability is more similar to that found in the human intestine. Our data suggests that MICA’ technology applied to Caco-2 drug permeability assay could be used to a better predict, using in vitro assays, the in vivo human drug absorption rates. This feasibility study will enable us to test rigorously against the gold standards and generate a new assay for the pharmaceutical market. Our research will lead ultimately to a reduction in animal research and more drugs coming through the pipeline to applications in healthcare.