10087635High-throughput bioprocessing system for cell therapy manufacturingClosedCollaborative R&DInnovate UKAutologous cell and gene therapies (aCGTs) have demonstrated curative potential in several therapeutic areas, such as blood cancers. In immuno-oncology alone, it is estimated that aCGT could be relevant for up to two million patients per year by 2030, compared to only ~5,000 patients per year receiving aCGT today. Taking into account other therapeutics areas, the projected number of patients that could benefit from aCGT could grow several folds higher. However, large-scale manufacturing is one of the bottlenecks to deployment due the autologous aspect (1 manufacturing batch = 1 patient dose). While there is a clear need for more bioprocessing automation, with several products in development targeting this need, unlocking mass-manufacturing of cell therapies also relies on 1) realistic footprint of manufacturing systems and 2) analytics automation. Firstly, the cleanroom footprint required to accommodate the projected volume of aCGT batches using current automated manufacturing systems would need to grow 30-fold by 2030 compared to current capacity. The speed of deployment in this timeframe poses a high risk and could become a major bottleneck to aCGT accessibility. This would also add significant costs to aCGTs, with aCGT manufacturer having to incur significant capital expenditure, making this sector less attractive. Secondly, Process Analytical Technologies (PAT) for aCGT enable control of the bioprocess and the final cell product. With current batch failure rates of up to 10%, there is a need for PAT-enabled bioprocessing equipment. At the same time, online PAT are expensive to deploy, with each instrument costing several tens of thousands of pounds. Fitting a set of PAT instruments across several aCGT batches would lower the cost barrier for cell therapy manufacturers operating several hundreds of systems in parallel. By leveraging MicrofluidX's current end-to-end automated single-batch bioprocessing platform, this project's goal is to build a prototype of a manufacturing system that can automate bioprocessing and analytics for several aCGT batches in a small footprint - The Manufacturing Stack.