PHC Corporation’s Biomedical Division (Head Office: Chiyoda-ku, Tokyo; President: Nobuaki Nakamura; hereinafter “PHCbi”), a global provider of laboratory sample storage and cell cultivation solutions and subsidiary of PHC Holdings Corporation (Head Office: Chiyoda-ku, Tokyo), announced the launch of its new cell expansion system LiCellGrow™ ^(*1) for research use in Japan and other select countries worldwide^(*2). The system is designed to improve quality and efficiency in the production of new advanced therapies by allowing therapy developers to visualize metabolic changes in cells in real time and automatically control culture conditions.

PHCbi will exhibit LiCellGrow™ at the 25th Congress of the Japanese Society for Regenerative Medicine, March 19-20 at the Kobe International Conference Center and Kobe International Exhibition Center in Kobe, Japan.

Cell and gene therapies (CGT), in which cells or genetic material are used to create personalized medical treatments, are rapidly advancing as promising treatment options for hard-to-treat diseases such as genetic disorders and cancer. In the manufacturing of CGT products, however, variations in cell characteristics and complexity of manufacturing are challenges to maintaining a consistent quality product. As a result, therapy developers are faced with reduced production efficiency, lower yields, and increased manufacturing costs compared to conventional therapies. To overcome these challenges, it is essential for therapy developers to be able to identify critical process parameters (CPPs) and critical quality attributes (CQAs) in CGT product manufacturing. The ability to monitor cell status and control culture conditions based on cell status are indispensable to developing quality CGT products at scale efficiently and at a lower cost.

PHCbi developed LiCellGrow™ to address these challenges and support CGT manufacturing at scale by helping to identify optimal culture conditions during the manufacturing process development. The system is equipped with proprietary In-Line monitoring technology that continuously measures, in real time, glucose and lactate concentrations, two key indicators of cell metabolism. It also incorporates culture control technology that adjusts cell culture medium at the optimal time based on these measurements. This technology is built on PHCbi’s proprietary electrochemical measurement platform, cultivated through more than 30 years of blood glucose sensor development. By visualizing the metabolic state of cultured cells, which is traditionally difficult to assess, and enabling precise control of culture conditions, LiCellGrow™ supports improved cell quality and enhanced efficiency as well as lower costs through reduced losses in the manufacturing of CGT products.

Under PHC Group’s Value Creation Plan 2027, which includes a focus on Diagnostics and Life Sciences, PHCbi is developing solutions to enhance efficiency and reduce costs in the manufacturing of CGT products. LiCellGrow™ builds on the In-Line monitoring technology introduced in LiCellMo™ ^(*3), a live cell metabolic analyzer launched in 2024 for research use only. From late 2026 through early 2028, PHCbi plans to expand its product lineup in phases, including culture bags with filtration functions that enhance cell recovery, pH/DO (dissolved oxygen) meter units, and cGMP-compliant dedicated consumables. These enhancements will support seamless scaling of CGT from basic research to commercial manufacturing in products such as CAR-T cell therapy.

[Key Features of the Product]

1. Automated Control and Optimization of Culture Conditions Using In-Line Monitoring Technology
By utilizing In-Line monitoring technology, LiCellGrow™ continuously tracks real-time changes in culture conditions and cell status, and automates medium exchange based on the acquired metabolic data. This enables the culture environment to be consistently maintained in an optimal state, contributing not only to improved cell quality and uniformity but also enhanced manufacturing efficiency. Furthermore, this process control approach aligns with the concept of Quality by Design (QbD) ^(*4), which embeds quality scientifically at the design stage rather than relying solely on final product testing. The system therefore supports the development of scientifically robust and highly reproducible manufacturing processes.

2. Single-Use Design Ensuring Aseptic Conditions and Highly Reproducible Cell Culture
LiCellGrow™ employs easy-to-attach, single-use dedicated culture bags. With automated measurement of culture conditions using In-Line sensors, the sampling tasks previously required to check glucose and lactate concentrations are no longer necessary. This reduces the risk of cross-contamination and enables closed-system cell culture that maintains aseptic conditions. In addition, the device can be placed inside a standard CO₂ incubator commonly used in laboratories, eliminating the need for special facility investments and allowing users to easily establish a reliable and highly reproducible culture environment.

Chikara Takauo, Director of PHC Corporation and Head of the Biomedical Division, commented:
“We are excited to launch LiCellGrow™ and offer therapy developers a new way to solve common challenges in quality, cost, and delivery of cell and gene therapies. Building on the success of our research-use system LiCellMo™, LiCellGrow™ represents an important step forward in making CGT manufacturing efficient, reliable, and scalable. We are committed to expanding our PHCbi offerings to continue to contribute to the adoption of CGT and other advanced therapy options for hard-to-treat conditions.”