CELL MICROSYSTEMS INC — Department of Health and Human Services SBIR Phase I: 400

Description

Project Summary Induced pluripotent stem cells (iPSCs) have become a commonly used tool to generate multiple cell types from a given individual patient. Reprogramming non-invasively harvested cells, such as dermal fibroblasts, into iPSCs, allows investigators to generate any cell type from a patient with known genetic and clinical backgrounds. This method has been particularly powerful for cases in which a disease condition manifests in a tissue where acquiring patient-derived primary cells is challenging, or there are genetic mutations. However, the workflows associated with reprogramming, CRISPR gene editing, and differentiating iPSCs are low-throughput, costly, time-consuming, and not supported by commercially available automated instrumentation. Customized automation systems have been published and generally require considerable capital investment, multiple types of equipment, custom programming, and commitment to a single reprogramming method. There is an unmet need in academia and industry for technology that can improve the efficiency and success rates of a) reprogramming, b) iPSC viability, and c) the ability to generate clonally derived CRISPR edited cell lines in an automated fashion. The development of streamlined workflows on a single platform that can deliver higher efficiencies in iPSC reprogramming and cell line development is likely to dramatically enhance the utility and throughput of the technology, thereby accelerating the use of iPSCs in personalized medicine and drug discovery. Cell Microsystems proposes the use of the CellRaft Technology, comprising the automated AIR System and CytoSort Array cell culture consumable as a cost-effective, automated, and gentle solution that can solve many of the pain points that plague these critical workflows. In this Phase I program, we will develop protocols for the culture, reprogramming, and editing of iPSCs using our proprietary consumable and instrumentation and demonstrate that our technology provides faster, more cost effective, and more efficient workflows for iPSC cloning. Commercially, there is a tremendous potential market in laboratories across all industries that perform these workflows, and our company has a proven successful track record in developing tools for the drug discovery market.Project Narrative Despite the advent of multiple sophisticated techniques for generating a clonal population of reprogrammed or edited induced pluripotent stem cells (iPSCs), there remains a clear need for a more automated, rapid, and cost- efficient means to identify, phenotypically characterize, isolate, and edit iPSC clones. The CellRaft AIR System and CytoSort array consumables are uniquely suited for alleviating pain points in the CRISPR and iPSC workflows such as low efficiency, low cell viability, and manual culture and isolation, to enable more efficient and robust cell line development for drug and therapeutic discovery pipelines.