Launch of LiCellGrow™ to Advance Cell and Gene Therapy Manufacturing
The Biomedical Division of PHC Corporation (PHCbi), headquartered in Chiyoda-ku, Tokyo and led by President Nobuaki Nakamura, has announced the launch of its new LiCellGrow™ Cell Expansion System for research use in Japan and selected international markets. PHCbi operates as a subsidiary of PHC Holdings Corporation and is globally recognized for its laboratory sample storage and cell culture technologies. The LiCellGrow™ system has been developed to enhance both quality and efficiency in the production of advanced therapies by enabling therapy developers to visualize cellular metabolic changes in real time and automatically regulate culture conditions based on those insights. By integrating monitoring and control technologies within a streamlined platform, PHCbi aims to address persistent manufacturing challenges associated with cell and gene therapies while supporting scalable, cost-effective development processes.
Industry Presentation and Scientific Engagement
PHCbi will showcase the LiCellGrow™ system at the 25th Congress of the Japanese Society for Regenerative Medicine, scheduled to take place on March 19 and 20 at the Kobe International Conference and Exhibition Center. The event provides a platform for researchers, clinicians and industry leaders to explore the latest advancements in regenerative medicine and advanced therapeutic technologies. By presenting LiCellGrow™ at this prominent congress, PHCbi is engaging directly with the regenerative medicine community and highlighting its commitment to supporting innovation in cell and gene therapy manufacturing.
Addressing Manufacturing Challenges in Cell and Gene Therapies
Cell and gene therapies are increasingly recognized as transformative treatment approaches for complex and previously difficult-to-treat diseases such as genetic disorders and cancer. These therapies utilize living cells or genetic material to deliver personalized treatment solutions tailored to individual patient needs. However, manufacturing CGT products remains complex and resource-intensive. Variability in cell characteristics, sensitivity to environmental conditions and intricate processing steps create obstacles to maintaining consistent product quality. Developers frequently encounter reduced yields, inconsistent batch performance and higher production costs compared to conventional pharmaceutical manufacturing. To overcome these barriers, manufacturers must clearly identify and manage critical process parameters and critical quality attributes that influence final product integrity. Continuous monitoring of cell status and responsive control of culture conditions are essential to building robust, scalable manufacturing platforms capable of delivering high-quality therapies reliably and efficiently.
Real-Time Metabolic Monitoring and Automated Control
LiCellGrow™ has been engineered to directly address these challenges by incorporating proprietary online monitoring technology capable of continuously measuring glucose and lactate concentrations in real time, two essential indicators of cellular metabolic activity. These measurements provide immediate insight into the physiological state of cultured cells, enabling more informed process control decisions. The system integrates automated culture control technology that adjusts the culture medium at optimal intervals based on acquired metabolic data. This intelligent automation is built upon PHCbi’s electrochemical measurement platform, developed through more than three decades of expertise in glucose sensor innovation. By visualizing metabolic conditions that were previously difficult to assess and by automating responsive adjustments, LiCellGrow™ enhances consistency in cell expansion processes, reduces manual intervention and minimizes waste associated with suboptimal culture environments. The result is improved cell quality, higher production efficiency and lower overall manufacturing costs in CGT workflows.
Alignment with Quality by Design Principles
A central feature of LiCellGrow™ is its alignment with the Quality by Design framework established in international pharmaceutical guidelines. Rather than relying solely on final product testing, the Quality by Design approach emphasizes integrating quality considerations during the process development phase. Through continuous online monitoring and data-driven control, LiCellGrow™ supports scientifically robust and reproducible manufacturing processes. Automated medium replacement based on metabolic signals ensures that the culture environment remains optimized, contributing to uniform cell populations and predictable expansion outcomes. This systematic approach enhances process understanding and reduces variability, which is critical for regulatory compliance and commercial-scale production of advanced therapies.
Single-Use Design and Closed-System Operation
LiCellGrow™ incorporates a dedicated single-use culture bag system designed for ease of installation and aseptic operation. Inline sensors enable automated measurement of glucose and lactate levels without requiring manual sampling, thereby reducing contamination risks and maintaining a closed-system environment. The elimination of repetitive sampling procedures not only enhances sterility but also improves operational efficiency by freeing personnel resources for higher-value activities. The device is engineered for placement within standard CO₂ incubators commonly used in laboratory settings, eliminating the need for specialized infrastructure investments. This compatibility allows research institutions and therapy developers to adopt the system seamlessly within existing facilities while establishing a highly reproducible and reliable culture environment.
Expanding the PHCbi CGT Portfolio
The launch of LiCellGrow™ builds upon PHCbi’s introduction of LiCellMo™, a live-cell metabolic analyzer released in 2024 for research applications. Under the PHC Group’s 2027 Value Creation Plan, which emphasizes growth in diagnostics and life sciences, PHCbi is advancing a portfolio of solutions aimed at improving efficiency and reducing manufacturing costs for CGT products. From late 2026 through early 2028, the company plans to expand its offerings to include culture bags with enhanced filtration capabilities for improved cell recovery, pH and dissolved oxygen measurement devices, and dedicated current Good Manufacturing Practice compliant consumables. These enhancements are designed to facilitate a smooth transition from research-scale development to commercial manufacturing, supporting advanced applications such as CAR-T cell therapy and other emerging immunotherapies.
Leadership Perspective on Innovation and Impact
Chikara Takauo, Director of PHC Corporation and Head of the Biomedical Division, emphasized that the introduction of LiCellGrow™ represents a meaningful advancement in addressing challenges related to quality, cost and timely delivery of cell and gene therapies. Building on the research-focused success of LiCellMo™, the new system is positioned to make CGT manufacturing more efficient, reliable and scalable. PHCbi remains committed to expanding its biomedical portfolio to accelerate adoption of advanced therapeutic solutions for complex diseases while supporting researchers and developers in their pursuit of innovation.
Corporate Background and Global Reach
Founded in 1969, PHC Corporation operates as a Japanese subsidiary of PHC Holdings Corporation, listed on the Tokyo Stock Exchange. The Biomedical Division supports life sciences research and healthcare providers in approximately 110 countries and regions through laboratory equipment, including CO₂ incubators and ultra-low temperature freezers. PHC Holdings Corporation oversees a diverse group of healthcare-focused subsidiaries delivering solutions in diabetes management, diagnostics, healthcare services and life sciences. With consolidated net sales of JPY 361.6 billion in fiscal year 2024 and distribution across more than 125 countries, the PHC Group continues to invest in technologies that enhance healthcare outcomes globally. Through innovations such as LiCellGrow™, PHCbi reinforces its commitment to advancing regenerative medicine and enabling efficient, high-quality production of next-generation therapies.
Source link:https://www.businesswire.com/
