-PHC Corporation Biomedical Division (Headquarters: Chiyoda-ku, Tokyo; President: Nobuaki Nakamura, hereinafter referred to as the "Biomedical Division") will present a prototype of its new cell expansion system, LiCellGrow, at the Europe 2024 Regional Assembly of the International Society for Cell & Gene Therapy (ISCT), which will be held in Gothenburg, Sweden, from September 4 to 6. LiCellGrow, which is currently under development, is designed to enable pharmaceutical companies to visualize continuous metabolic changes in cells in real time and automatically adjust cell culture to optimize conditions for cell growth. The system is designed to increase the availability of cell and gene therapy (CGT) products by accelerating the production of the specific cells needed for these therapies.

CGT, in which the patient's own cells are removed, modified and returned to the body to fight disease, has become a promising therapeutic field for difficult-to-treat diseases such as cancer and haematological disorders. Since the patient's own cells are used as raw material, it is crucial to maintain stable cell quality during the production of new cells in order to counteract natural fluctuations in cell properties and to ensure consistent quality throughout the manufacturing process of the therapy. The current method of evaluating cell quality by taking samples of the final product can reduce both manufacturing efficiency and yield, and increase production costs.

LiCellGrow is designed to enable more efficient and stable manufacturing of high-quality CGT products by giving researchers the ability to monitor and control the cell culture environment in real-time to optimize cell quality while minimizing disruption to the therapy manufacturing process.

The system under development uses proprietary in-line monitoring technology that continuously measures cell metabolites in the culture medium without the need for repeated sampling by immersing the sensors in the medium at all times. LiCellGrow then continuously and accurately measures the concentrations of two critical indicators of cell metabolism, glucose and lactate, to provide visualization of the actual changes in the culture environment and cell status. Based on the real-time measurement data, the system then automatically replaces the culture medium to keep the culture environment in optimal condition. This technology is designed to improve and homogenize cell quality while increasing cell culture efficiency and reducing costs by reducing losses. The system also features easy-to-install single-use toiletry bags with in-line sensors that enable cell culture in a closed system to maintain a sterile environment and can be integrated into existing CO₂ Incubators can be built in, allowing researchers to conduct their studies using their preferred equipment.

LiCellGrow is an example of the synergy between the Biomedical Division and the IVD Division (hereinafter referred to as "IVD") of PHC Corporation. The in-line monitoring technology used in this cell expansion system is a newly developed proprietary technology that builds on the core technology of the blood glucose sensor, IVD's lead product. By combining IVD's sensor technology with the Biomedical Department's advanced cell culture environment control technology, PHC aims to add greater value to researchers and pharmaceutical companies.

The Biomedical Division plans to launch LiCellGrow in the near term to support the development of manufacturing processes for CGT products globally and aims to accelerate the development of this system to ultimately support the commercial production of CGT products.

LiCellGrow builds on the Biomedical Division's 20-year history of developing breakthrough solutions in the field of cell therapy, including the Cell Processing Center^*1 in 2000 and the Cell Processing Isolator ^*2 in 2007. Going forward, we will continue to drive the development of innovative solutions that address QCD (quality, cost, delivery) challenges in the therapeutic manufacturing process to enable early adoption of CGT and thus contribute to the advancement of modalities (therapeutic methods).