Providing New Predictive Insights into Cell Therapy Process Development and Manufacturing Outcomes
Cell therapy is the administration of cells into the body to cure disease or promote healing. One form is using cells from the patient’s own body, modified either ex-vivo or within their native environment, called autologous therapy. Several autologous chimeric antigen receptor (CAR)-T cell therapies have been approved by the FDA and many more are the subject of ongoing clinical trials. The other major type of cell therapy is called allogeneic therapy wherein cells are removed from an individual donor source and then manufactured for many patients and available “off-the-shelf”. The ultimate goal for allogeneic therapies for many is the biomanufacturing of products from multiple donor sources, which are then pooled together in quantity and modified or processed before administration to other patients. Cell therapies include blood transfusions, stem cell transplants, gene modification cell therapy, and induced pluripotent stem cell (iPSC) therapy.
The Challenge
Cell therapy development and manufacturing face analytical challenges in ensuring the consistent quality, purity, and potency of therapeutic cells. Precise characterization, real-time monitoring, and standardized assays are critical for navigating the complexities of heterogeneous cell populations, optimizing processes, and meeting stringent regulatory requirements. The innate cellular variability across donors and patients introduce significant complexity from the start into the development and manufacturing of these life saving treatments and cures.
Our Solution
LumaCyte’s Radiance® platform is revolutionizing cell therapy analysis by providing real-time, label-free, quantitative and predictive cell characterization. Leveraging cutting-edge Laser Force Cytology™ (LFC) technology, Radiance® offers comprehensive monitoring of cellular starting material and precise quantification of production processes and potency. This advanced analytical solution allows researchers to gain valuable insights into cellular responses, including cell health, expansion, activation, differentiation, and killing efficiency, facilitating a deeper understanding of cellular behavior across important process development and production steps.
Radiance® ensures highly precise measurements, offering developers a more detailed understanding of cellular responses and enhancing the overall characterization of cellular behavior. This capability enables manufacturers and production scientists to rapidly assess the quality of cellular starting materials while also enabling the optimization of key production processes across complex manufacturing steps.
By providing real-time insights into cell conditions, Radiance® saves valuable time and resources, ensuring life saving treatments are delivered faster to patients in need. This innovative platform is transforming the field of cell therapy analysis, ensuring higher product consistency and quality, and paving the way for the development of safe and effective therapies.
Rapid and Real-Time Analysis
LumaCyte’s Radiance® instrument employs Laser Force Cytology™ (LFC) technology for immediate and continuous monitoring of cellular response from starting material qualification to expansion, activation, differentiation, potency.
Label-Free Measurements
Radiance® provides label-free analysis, eliminating the need for external markers and allowing developers to focus on the intrinsic biological innate properties of cells.
High Precision
Radiance® ensures highly precise measurements delivering consistent and reproducible assay results across complex process development and manufacturing processes.
Laser Force Cytology™ (LFC) is transforming cell therapy analytics through its real-time, label-free precision measurement of cellular responses. This enables rapid optimization of production processes, ensuring consistent product quality, and improved understanding of cellular behavior, ultimately leading to safer and more effective cell-based therapies.
Understanding Macrophage Behavior Using Laser Force Cytology™
Macrophages play a vital role in cell therapy development as key regulators of the immune system, influencing the success and efficacy of therapeutic interventions. They are also being investigated as immunotherapies themselves through the development of CAR-M cell therapies. Understanding and manipulating macrophage behavior is essential for creating strategies that optimize the interaction between transplanted cells and the host environment, ensuring improved tolerance and longevity of cell therapies.
LumaCyte’s Laser Force Cytology™ excels in characterizing macrophages by providing nuanced insights that traditional flow cytometry methods may overlook. Through its label-free, single-cell analysis capabilities, Laser Force Cytology™ reveals intricate details in macrophage behavior, allowing for the detection of subtle analytics that might go unnoticed using conventional techniques.
