New Cell Expansion System to Support Development of Cell and Gene Therapy Products Manufacturing Process.
Real-Time Cell Culture Management Technology Seeks to Accelerate Production of New Therapies
LiCellGrow, currently under development, is designed to allow pharmaceutical companies to visualize continuous metabolic changes in cells in real-time and adjust the cell culture automatically to optimize conditions for cell growth. The system seeks to expand the availability of cell and gene therapy (CGT) products by accelerating the manufacturing of specific cells needed for these therapies.
CGT, in which a patient’s cells are removed, modified, and reintroduced to the body to fight disease, has emerged as a promising therapeutic field for difficult-to-treat conditions such as cancers and hematologic disorders. Since the patient’s own cells are used as raw materials, it is essential to maintain stable cell quality when producing new cells, to counteract natural variations in cell characteristics, and ensure consistency throughout the therapy manufacturing process. The current method of evaluating cell quality by sampling the final product may lower both manufacturing efficiency and yield, increasing production cost.
LiCellGrow seeks to enable more efficient and stable manufacture of high-quality CGT products by enabling researchers to monitor and control the cell culture environment in real time, optimizing cell quality while minimizing interruption to the therapy manufacturing process.
The system under development uses proprietary In-Line monitoring technology, which continuously measures cell metabolites in the culture medium without the need for repeated sampling by immersing sensors in the medium at all times. LiCellGrow then continuously and accurately measures concentrations of two critical indicators of cell metabolism, glucose, and lactate, to offer a visualization of actual changes in the culture environment and cell status. Based on real-time measurement data, the system then automatically exchanges the culture medium to maintain the culture environment in an optimal state. This technology is designed to improve and homogenize cell quality while increasing cell culture efficiency and reducing costs through loss reduction.
The system will also feature easy-to-install single-use culture bags with In-Line sensors, enabling closed-system cell culturing to maintain a sterile environment, and can be installed in existing CO2 incubators, enabling researchers to conduct studies using their preferred equipment.