ThinkCyte today announced the publication of a joint research paper together with Astellas Pharma Inc, in the September 19th issue of Scientific Reports showcasing the potential of its Ghost Cytometry® technology for quality control (QC) in cell therapy product manufacturing. As the clinical use of cellular therapies in oncology and autoimmune conditions explodes, the need for efficient and reliable methods to ensure the quality of cell therapy products has become increasingly important. Current QC processes for cell therapy manufacturing involve complex analytical tests, including fluorescence-based flow cytometry, which requires skilled operators, is prone to variability, and can be costly to perform due to the requirement of using expensive antibodies.
The new study explores the use of VisionSort™, ThinkCyte’s AI-driven, label-free cell sorter powered by Ghost Cytometry technology, to perform quality control assays on cell therapy products. By analyzing the morphological characteristics of cell therapy products label-free, the technology was tested for its potential to act as a minimally disruptive cell characterization tool in various stages of cell therapy manufacturing.
Key findings include the accurate classification and quantification of human peripheral blood mononuclear cells (PBMCs), distinguishing between live and dead cells, identifying early apoptotic cells, and differentiating between T cells and non-T cells. The study also demonstrates the ability of Ghost Cytometry to detect contaminants, such as microparticles, that can commonly accumulate in cell therapy development workflows.
The results highlight the potential for Ghost Cytometry to monitor cell counts, assess cell viability, and identify specific cell subsets without the need for fluorescent dyes as part of cell therapy development and manufacturing. The approach offers a less invasive and more cost-effective approach to selecting cells for therapeutic use and is expected to contribute to greater efficiency, improved automation, reduced costs, and improved product quality in the cell therapy manufacturing process.
The study was conducted by Kazuki Teranishi, Product Manager at ThinkCyte, Keisuke Wagatsuma, Senior Scientist at ThinkCyte, along with Shinya Takahashi, Manager of Process Engineering, CBTL in Astellas Pharma Inc., Hideto Yamaguchi, Head of CBTL in Astellas, and Sadao Ota, Associate Professor at the University of Tokyo.
Open access to the publication can be found at https://www.nature.com/articles/s41598-024-72016-8
