On February 10, 2025 PHC Corporation reported to have signed a Master Collaboration Agreement with CCRM to work together on the development of primary T-cell(*1) expansion culture processes that will seek to accelerate the manufacturing of cell and gene therapy (CGT) products (Press release, CCRM, FEB 10, 2025, View Source [SID1234650119]). This joint initiative will integrate "LiCellGrowTM(*2), PHC’s cell expansion system under development, with CCRM’s deep knowledge of regenerative medicine and biomanufacturing to establish new culture processes to improve cell culture efficiency and quality for CGTs.
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Primary T-cells are used in process development and manufacturing for CGTs, such as in CAR-T cell therapy.(*3) However, primary T-cells derived directly from patients often exhibit significant variability in growth rates and quality, making it challenging for researchers to ensure stable cell counts and maintain quality throughout the culture process. To address these challenges and improve the quality of cell-based therapeutics, better cell culture processes are needed.
Chikara Takauo, Director of PHC and Head of the Biomedical Division that leads the company’s Life Science business, commented: "We are delighted to begin this joint research and development initiative with CCRM, a leader with 14 years of experience in the commercialization of regenerative medicine and CGT. By combining the technologies and expertise of both of our organizations, we aim to advance the manufacturing processes for cell-based therapeutics and cell culture technologies, contributing to the early practical application of CGT."
PHC has developed proprietary In-Line monitoring technology to track key indicators of cell metabolism in real-time, which can help researchers address issues like cell quality and reproducibility, and establish optimal cell culture methods. This technology enables precise, continuous measurement of glucose uptake and lactate production during cell culture, providing a more precise understanding of changes in cell metabolism over time than is possible to observe using traditional sampling methods. In 2024, PHC launched the live-cell metabolic analyzer "LiCellMoTM(*4)" incorporating this technology in the United States, Canada, Europe and some Asian markets including Japan, China, Singapore and Taiwan.
Building on this technology, the company is also developing "LiCellGrow," a cell expansion system designed to exchange media automatically based on the metabolic state of the cells and to maintain the culture environment in an optimal state. PHC aims to further expand its product lineup to seamlessly support research, process development, and commercial manufacturing of cell-based therapeutics.
"We are excited to collaborate with PHC to unlock new possibilities in cell culture," explained Michael May, President and CEO of CCRM. "Technology development partnerships, like this one, are key to advancing the industry and making CGT more cost effective, and therefore more accessible to patients around the world."
The joint research with CCRM will allow PHC to analyze culture conditions using "LiCellGrow" to establish optimal culture processes for primary T-cells. The collaboration will seek to accelerate LiCellGrow’s development, contributing to improved cell quality, enhanced manufacturing efficiency, and cost reduction in the production of cell-based therapeutics.