SBIR Phase I: Ratcheting Cytometry Instrument for Performing Cell Therapy Quality Control Assays

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) project will be the development of an instrument to address the scaling and regulatory challenges of quality control that increase cost and impede large scale deployment of cellular therapies to a wide patient base. Cellular therapies taking advantage of engineered human cells have shown incredible potential as "living drugs" that achieve personalized therapies for cancer patients. Recent improvements in these therapies have shown their efficacy in targeting and killing specific types of leukemias. In light of these successes, more and more research and clinical trials are being proposed to improve current efficacy in treating blood cancers and adapting these therapies to other cancers types. While showing promise in the fight against cancer, there is growing concern over the manufacturability of clinical doses, especially when scaling up to meet global demands. Additionally, the speed at which these therapies are being developed is causing regulatory agencies to lag behind in terms of quality control and release criteria. Both of these issues will need to be addressed as cellular therapies continue to improve and increase in demand. This SBIR Phase I project proposes to develop an integrated quality control instrument for the manufacture of cellular therapies, which centers around a disruptive new technology called ratcheting cytometry. Currently, quality control of therapeutic cell batches remains difficult to standardize and scale given the plethora of standalone tools needed to adequately characterize each batch. This modular approach has high capital cost, high recurring maintenance costs, and requires skilled technicians. Ideally, the capabilities of these standalone tools can be combined into one automated system to provide standardized metrics for cellular therapy quality without user variability. Leveraging well-established immunomagnetic cell labeling techniques, ratcheting cytometry is able combine the capabilities of quality control tools by individually measuring magnetic content and gating based on surface expression. Leveraging these advantages, the goal is to demonstrate feasibility for an integrated instrument to quantify cell number, viability, surface expression, and cytokine secretion of therapeutic cell batches in a single step assay.