104377Improving T-Cell manufacture through automation - scaling out, reducing costs and increasing quality to meet the emerging demand for patient-tailored cancer therapies.ClosedCollaborative R&DInnovate UK"**Objective:** Improve scalability, quality, costs, flexibility and efficiency of T cell manufacturing by developing and integrating novel processes and manufacturing technologies. **Need or Challenges**: While T cells have been shown to produce game-changing results by curing previously untreatable cancers in numerous clinical trials, the T-cell manufacturing and production capabilities are greatly lagging, and will not be able to meet the predicted surge in demand unless new technology and processes are developed. T cells are currently produced via labour-intensive, manual culture in flasks, or in bioreactors with limited scaling capabilities. These methods are sufficient to carry out R&D and Phase I clinical trials; however, they are inadequate on a yield, economic, and quality/regulatory level (due to inconsistencies and cross contamination risks) to produce the hundreds to thousands of doses per year that are required for Phase II-III clinical trials and commercialisation. These shortcomings, if not resolved, will hinder these life-saving therapies from reaching the market or from being accessible to all patients. **Approach:** Aglaris (a UK SME) and University College London will collaborate to fully develop and integrate the following technologies which will enable T-cell production to meet the upcoming surge in demand in a few years, as more live-saving T cell therapies (currently in clinical trials) receive regulatory approval: 1. Plug and play T cell culture cartridge: more space efficient, uses up to 14X less cytokine, less labour-intensive processes, and lower cell production costs (up to 35% savings). 2. Cost-efficient, in-line, disposable sensors: measure parameters in real time without extracting samples, resulting in reduced labor and costs, more tightly controlled processes for increased production (more cells in less time by maintaining optimal proliferation settings, quality and GMP regulatory compliance. 3. Modular process: Serial expanding chambers for easy scale up and fully enclosed separate modules to grow multiple lots in parallel for scale out without cross contamination risks. This will help with scaling and logistic problems as well as GMP compliance. **Outcome:** Create a ready-to-launch new system to manufacture T cells in a way that can be scaled up (for allogeneic therapies) and scaled out (for autologous therapies), with the predicted quality and yields that will be necessary to bring these life-saving therapies to the market, both in the UK and worldwide, just in time as numerous T-cell therapies receive regulatory approval (the first 2 received regulatory approval in 2017, and 240 are in clinical trials)."