Healthcare costs, manufacturing inefficiencies and population growth contributed to a substantial increase in the number of individuals struggling with dangerous or chronic diseases. For instance, the IDF Diabetes Atlas (2021) reports that 10.5% of the adult population (20-79 years) has diabetes, with almost half unaware that they are living with the condition. By 2050, society will need a healthcare system capable of providing 10bn people with accessible and cost-effective diagnostics and treatments.
C> has the potential to solve this global challenge. C> treatments Care transforming how metabolic diseases, neurology and infectious diseases are treated and potentially cured, significantly changing healthcare outcomes.
However, current cell-manufacturing technologies in this nascent field are inefficient and expensive for the scale this market needs to achieve. The first autologous therapy was approved by the FDA in 2017\. By 2022, there were only 27 FDA-approved C>s, representing approximately 8% of the 340 approved biologics, only a small fraction of conventional drugs. This creates a substantial need for innovative solutions to provide a scalable and efficient cell-manufacturing process.
To solve this need, CellulaRevolution Ltd (CellRev) has developed a highly innovative bioreactor system allowing continuous manufacture of adherent cells. CellRev's innovation will expedite the scaling up of allogeneic cell therapies, which will help address health access treatment of dangerous and chronic diseases in the UK and globally.
This is a truly unique and breakthrough solution in cell-culture that can potentially manufacture 45x current yields, significantly reduce consumable usage by substituting the current single-use batch culture tech, and lower capital & operating costs by 94%.
Red blood cells (RBCs) are currently harvested from donors and represent the most common form of cell-based therapy. There is an urgent need for RBCs for transfusion, and this demand is predicted to rise as the population continues to have longer life expectations. In light of this, there has been considerable research advancement to generate RBCs in vitro starting from different precursor cells, however there are no technologies enabling the scaling-up of the process in order to meet the current and future demand of cells. In addition, high-scale production of RBCs is relevant for other applications/markets. For instance, it has been shown that organs that are re-perfused with blood substitutes have a greater transplant success and clean meat companies would be interested in adding a safe, animal-free and affordable source of RBCs to improve the taste and texture of their products. In light of this, CellulaREvolution is willing to undertake industrial research to test/adapt its smart coating technology for the continuous production of RBCs.
CellulaREvolution is a company that recently spun-out from Newcastle University with a highly innovative technology that allows the continuous manufacture of cells. Our novel approach is to move from the traditional batch culture (with its overly complicated ways to increase surface area) to a continuous culture system where cells are produced unremittingly. Cells are currently grown in batches, the size of each batch limited by the surface area upon which the cells are attached (e.g. flask size). Importantly, batch culture technologies are not able to meet the demand for cells for different applications that we believe our continuous technology can address.
This project aiming at exploring our process for the continuous manufacture of RBCs, can have a great impact on the end users (i.e. patients) while helping the company growing, raising more investments, generating know-how and IP. Moreover, after its completion, other companies could also benefit from this project since we aim to test the newly developed technology via collaborations/partnerships.
"There are a number of well-established and emerging commercial markets exploiting scientific advances in growing living cells to 'manufacture' new products, including pharmaceutical drugs, stem cells, gene therapies and cell-based meat. Companies working on these developments are addressing some of the major challenges facing the world over the coming decades, such as global hunger, global warming and pandemic threats.
Many of these applications rely on the use of adherent cells (cells requiring a solid surface on which to grow, such as the bottom of a culture flask). The standard approach to growing adherent cells has not changed in 50 years; cells are grown in batches, the size of each batch limited by the surface area upon which the cells are attached (_e.g_. flask size). Critically, traditional batch bioprocessing techniques for the culture of adherent cells cannot meet current demands (typical lot sizes are 10e^10 cells but needs in some markets are more in the range of 10e^30) and is therefore a significant bottleneck to the future commercial potential of companies that produce or use adherent cells.
A radical departure from traditional engineering solutions is required, _i.e_. an alternative to simply increasing surface area by using microcarriers, hollow fibres or multi-layered flasks, as these approaches can never practically meet the growing demand. At CellulaREvolution we aim at establishing a revolutionary method to culture adherent cells in serum-free medium. Our novel approach is to move from the traditional batch culture (with its overly complicated ways to increase surface area) to a simple continuous culture system where cells are produced unremittingly. Our innovation facilitates such an approach for the first time.
In light of this, the current proposal will enable the setting up of CellulaREvolution as a business via the appointment of a CEO, hiring qualified team members, renting lab/office space, paying for consultancy, legal costs and further market research. Accelerating the company development at this stage, will help CellulaREvolution to attract private investors to financially support initial development and sales of its products."