10114795Speed-CELL: Accelerating Cell Therapy Release for Rapid Clinical DeploymentClosedCollaborative R&DInnovate UKImmune cells such as T cells can be harvested from a patient's blood and genetically engineered to recognize and destroy cancer cells. This kind of immune therapy, which includes CAR T cell therapy is proving to be highly effective in treating cancers which have become resistant to chemotherapy and radiotherapy. There are currently six such engineered immune cell therapies licensed which are revolutionizing the treatment of many cancers. Many more cell therapies are under development. The greatest challenge for this treatment approach is that an individual treatment must be manufactured for each patient, which is expensive. Alternative approaches such as manufacturing "off-the-shelf" immune cells has not worked well. However, manufacturers of engineered cell therapies have developed processes that are automated, and which are much shorter. These are reducing the cost of these therapies. Standard therapeutics are manufactured and released in large batches of thousands of doses so that release testing is a small part of cost and complexity per dose. With individualized manufacture however, each patient's product requires its own release testing and product release. Notably, release testing of engineered immune cell therapies is complex and expensive. With quicker automated manufacturing, product release is now becoming a bottleneck, with release testing taking up an increasing proportion of total cost of goods. The overall aim of Speed-CELL is to make batch release cheaper and faster, but still ensure that only high-quality products get to patients. This will reduce the cost of these cell therapies. Importantly, it will reduce the waiting time for patients who often have aggressive cancers. The speed-CELL will achieve this primarily through broad engagement - we will build an expert consortium of UK academics, medical centres, industrial partners to inform and work with governmental agencies, such as regulators, to develop release testing technologies and processes which will reduce the cost and time take to release engineered cell therapy products. More specifically, Speed-CELL consortium will: \* Assess the UK cell manufacturing landscape to identify release critical bottlenecks e.g. testing for sterility and product potency. \* Identify cutting-edge analytic technologies that can be adopted to streamline and accelerate release. \* Develop digital technologies like expert systems which can automate release. \* Establish regulatory pathways to enable these methodologies and technologies. This initial funding will help lay the groundwork for this ambitious project which will act to increase competitiveness of UK academic and industrial cell therapy groups and bring these therapies faster to patients.