LumaCyte Unveils Predictive CAR T Donor Analytics to Revolutionize Cell Therapy Manufacturing

Charlottesville, VA – September 4, 2024 – LumaCyte, a leader in advanced cellular analysis and precision bioanalytics, proudly announces the launch of its groundbreaking cell therapy application for predictive CAR T donor analytics. Leveraging its novel Laser Force Cytology™ (LFC™) technology and Radiance® instrument, LumaCyte uncovers deep data insights into highly variable and complex patient and donor cellular starting material, enabling cell therapy developers to predict manufacturing success for specific donors or patients. To ensure that all interested partners can benefit from this powerful new application, LumaCyte has introduced a new donor qualification service where customers can ship donor or patient samples to LumaCyte for analysis and qualification. This service aims to revolutionize the cell therapy landscape by minimizing manufacturing risks due to variability in cellular starting material, enhancing production consistency, and increasing production yields.

The industry has long sought to understand the innate variability across donors and patients and how to predict manufacturing and clinical success based on biomarkers in the cellular starting material. The ability to predict the outcome prior to the start of manufacturing with near real-time analytical insights is considered the holy grail for donor selection. Combining advanced in-process analytics with the ability to enable adaptive manufacturing would be a quantum leap for the immunotherapy industry; Reducing manufacturing failures and compressing time and costs for delivering these lifesaving treatments.

“The biopharmaceutical industry is advancing scientific breakthroughs into the clinic faster than any other time in its history. Developers must think differently from the start to be able to meet the clinical and commercial manufacturing scale required to serve the hundreds of thousands of advanced therapy patients expected by 2030. “We are honored to do our part in providing valuable real-time data insights that have the power to accelerate the time to patient as well as improve the cost and effectiveness of these lifesaving treatments,” says Dr. Sean Hart, LumaCyte CEO and CSO.

Regulatory bodies are increasingly emphasizing adaptive manufacturing and comprehensive qualification of starting materials to ensure consistency and reproducibility. LumaCyte’s new predictive CAR T donor analytics capability addresses these demands with real-time, label-free, quantitative cell characterization. This enables precise and reliable qualification of donor cells, predictive of manufacturing success, and functional potency measurements throughout the process. Starting with high-quality materials helps manufacturers avoid failures and when combined with adaptive manufacturing, can significantly reduce treatment costs and expand patient access.

The introduction of predictive CAR T donor analytics marks a transformative leap for the cell therapy community. Utilizing LumaCyte’s Radiance® platform technology, researchers and manufacturers can achieve unparalleled accuracy and efficiency, ensuring reliability across cellular analysis workflows. This innovation enhances the quality and consistency of CAR T cell therapies while significantly reducing costs, making these life-saving treatments in the future more accessible to patients in need.

About LumaCyte

LumaCyte, Inc. is an advanced research and bioanalytics instrumentation company that produces label-free, single cell analysis instrumentation where the use of antibody or genetic labeling is not required for cellular analysis. This revolutionary technology utilizes Laser Force Cytology™ (LFC™) to measure optical and fluidic forces within a microfluidic channel, quantitatively characterizing innate cellular responses of subtle phenotypic changes based purely on the intrinsic biophysical and biochemical properties of cells, which can be used to measure cellular changes in response to their environment or treatment. The univariate and multivariate nature of the data has enabled a host of big data strategies and cloud computing capabilities that drive advanced analytics, allowing a deeper understanding of cell based biological systems. Applications of LumaCyte's label-free platform technology include viral infectivity for vaccine development and manufacturing, cell health, activation, transfection and transduction analytics for cell and gene therapy development and production monitoring, CAR T-cell immunotherapy, iPSC differentiation, adventitious agent testing (AAT), infectious disease, and pre-clinical drug discovery, in addition to multiple applications across advanced therapy biomanufacturing for real-time quality control.

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