Current delivery of cells for drug discovery has severe drawbacks that prevent efficiency and market availability. Typically, cells are shipped cryopreserved within the UK and internationally. Maintaining the cells in a frozen state is one of the biggest challenges in cell transportation and requires the use of heavy, non-environmentally friendly dry ice packaging or liquid nitrogen. This limits the regions of supply and impacts time frames of delivery. Cells can thaw due to customs delays, making them unusable. Costs of dry ice have increased in the last year with recent fears of shortages and a high environmental costs of manufacture. These challenges together create a complex, uncertain, expensive process that is limited to specific regions of the world. This project focuses on developing a product that will allow for cells and cell models to be stored long-term via cryopreservation as well as be shipped at room temperature, removing the need for ultra-cold transportation. The developed products ("CytoStor-Cryo" for cryotube formats and "WellReady-Cryo" for assay-ready formats) will remove the need for dry ice completely, reducing the costs of shipments, reducing the uncertainty associated with the availability of dry ice as a resource, increasing the geographical range of shipment, and eliminating the risk of cell thawing, death and product recall. This will allow companies to move away from making cells to order within a specific timeframe, and instead they can store cells long term and ship them out on demand. Reduced logistical cost, complexity, and failed shipments will be greatly beneficial to the UK's growing cell biosupply sector and will increase growth and profitability, thus having an overall positive effect on the economy. This will benefit drug discovery, biomedical research and healthcare by increasing the availability of cells/cell models and reducing reliance on animals. Integrating cryostorage with ambient transport will revolutionise cell biosupply.

As the UK shifts towards an ageing population the rates of disease associated with ageing, including cancers, will rise and the UK healthcare system will be placed under additional stress. To improve disease diagnostics and treatment, the healthcare sector is moving towards a more personalised, individually focussed approach. However, research and development in this area relies on access to high-quality, fresh, viable tissue biopsy samples. Currently, most biopsies are processed so that the tissue is no longer viable or fresh, and there is no clinically available solution to preserve biopsies fresh. As such, the shelf-life of fresh patient samples is very short at a few hours, which can lead to patient tissue being wasted as well as placing severe limitations on the development of novel diagnostic and therapeutic assays. A technology has been developed that enables the safe storage of fresh biological samples, extending their lifespan at room temperatures. This technology has effectively preserved a wide range of cell types, such as stem cells, primary skin and blood products. Furthermore, the technology is being applied to pioneering therapies, currently undergoing clinical trials, that use live cells to treat diseases and conditions that cannot be successfully treated with conventional drugs. This project proposes to extend this technology to design a novel and innovative storage application to preserve biopsy samples at room temperature, extending the viability of testing samples beyond their limited shelf-life. This would enable the advancement of novel and specific therapeutics based on more complex and physiologically relevant cancer models. This new biopsy storage application would consist of a kit that is simple and quick for healthcare professionals to use. By eliminating the need to immediately fix or freeze tissue samples, the number of downstream applications is dramatically increased and allows for sensitive assays that require genomic or viable samples to be performed. Ultimately, to ensure the growing number of disease cases are managed efficiently, both from an economic and social perspective, healthcare will have to rely on more specific and complex methods to diagnose, monitor and treat disease. A product like this has the exciting potential to accelerate the development of these novel solutions to improve disease management and patient outcomes.

Good fertility performance is the cornerstone of a profitable and sustainable livestock enterprise. In the international dairy and beef herd, optimum performance is achieved by maintaining a calving interval (CI) of 365 days. Every day CI increases \>365 days is estimated to directly cost the farmer ~GBP2.07/CAN$3.54/cow, or more for high yielding dairy cows. Fertility drives productivity and in turn the mitigation of greenhouse gas (GHG) emissions through reduced waste and optimising unproductive replacement youngstock inventories. This project will research and develop a number of innovative new technologies and establish national level referral facilities for quality assurance and improvement of bovine germplasm, as an integrated bilateral approach. The outputs of the project will transform genetic progress, through adoption of precision technologies, diagnostics, advanced breeding and big data, leading to more sustainable livestock food production and export opportunities in both UK and Canada.

More than 380,000 people have been tested for COVID-19 in the UK, with less than 20,000 samples being collected daily. The government plans to escalate testing more than five-fold to 100,000 daily samples. However, a severe limitation of swab samples which collect infected cells from the upper respiratory tract is their short shelf-life of only 48-72 hours at 2-8°C. Cells are fragile and unable to survive outside their normal environment, limiting the amount of time they can be tested to detect the SARS-CoV-2 virus. Expired samples can no longer be used for reliable diagnostic purposes, and would lead to patients needing to be re-tested. A technology has been developed that enables the safe storage of biological samples, extending their lifespan at room temperature. This technology has effectively preserved a wide range of cell types, such as stem cells, primary skin and blood products. Furthermore, the technology is being applied to pioneering therapies, currently undergoing clinical trials, that use live cells to treat diseases and conditions that cannot be successfully treated with conventional drugs. This project proposes to use this technology to design a novel and innovative storage appliance to preserve swab samples at **room temperature** to extend the viability of testing samples way beyond 72 hours (up to two weeks). This would contribute to the government's goal of increasing daily testing for COVID-19, by allowing more patient samples to be collected as they can be safely stored for longer, or transported further to centralised testing facilities. This new swab-storage product would consist of a kit that is simple and quick for healthcare professionals to use. A novel preservation kit such as this is essential to extend the shelf-life of patient samples for COVID-19 testing. More flexibility in the timeframe for swab samples to be tested would ultimately result in more samples being able to be collected and therefore more patients being diagnosed. Additionally, increased testing can help direct government policies on social and workplace policies, which would help the economy and wellbeing of UK residents. A product like this has the potential to optimise global disease testing for COVID-19, and in the future could be applied to other disease diagnostic kits. The effects of Extension for Impact funding will enable Atelerix to extend the positive impacts learned within this project to enable further applications in COVID-19 research, diagnostics, and application to existing and emerging viruses. Key findings suggest that Atelerix's technology can be utilised for the preservation of upper airway epithelial cells, the cells that coronavirus infect. The development of clinical treatments, such as anti-virals and vaccines, to limit the spread or severity of coronavirus is a global health priority. Cell models are critical to understand the infection biology, growth kinetics and mechanism of action of coronavirus. The use of Atelerix’s technology to store and distribute airway epithelial cell models can have a direct impact on Research and Drug Discovery, and the ultimate development of new treatments. In addition, the Extension for Impact funding will allow Atelerix to explore how the novel product developed within this project could be applied to other infectious diseases for monitoring and reducing the risk of future pandemics.

"Therapies using live cells offer the possibility of treatments for diseases and conditions that cannot be approached by conventional drugs. Cells are being investigated for their abilities to reverse blindness, re-grow bone and nerves, restore the immune system and treat cancers for which there are no effective drugs. Living cells, however, are fragile and short-lived outside their natural environment. A common approach to address these issues is to freeze the cells for storage but this causes problems when the cells are thawed again for injection into the patient. Many cell therapies simply cannot be frozen and for these products complicated and expensive logistics are required to ensure their delivery to the hospital and the patient before their shelf life expires. A technology has been developed that enables the storage and transport of unfrozen human cells, thereby preserving and extending their functional viability. The technology has been shown to be effective with a wide variety of cell types. This technology has the potential to make cell therapies widely available to many more patients who need treatment. The proposed project will explore options for stabilising the active cells contained within a specific cell therapy product, preventing their deterioration and therefore extending the shelf-life. The product is being trialled in a clinical stage program and is therefore an excellent exemplar to demonstrate the potential of the technology. Extending the shelf-life is necessary to ensure that hospitals have flexibility to schedule operating theatres to administer the product and therefore enable as many patients as possible to be treated with novel, potentially curative therapies. Managing global logistics by this approach can also allow for more efficient manufacturing (fewer manufacturing plants needed, for example), reducing the costs of production and making the therapies more affordable and widely available."