Revolutionizing Cell and Gene Therapy Production: PHCbi's LiCellGrow™ System
PHCbi introduces a groundbreaking solution to transform cell and gene therapy manufacturing. With the launch of the LiCellGrow™ Cell Expansion System, PHC Corporation's Biomedical Division aims to revolutionize the production of advanced therapies, addressing critical challenges in quality, efficiency, and cost.
But here's where it gets exciting: LiCellGrow™ is designed to support the development of high-quality cell and gene therapies by providing real-time insights into cellular metabolism and automated control over culture conditions. This innovation promises to streamline the manufacturing process, making it more efficient and cost-effective.
Unlocking the Potential of Cell and Gene Therapies
Cell and gene therapies (CGT) are emerging as powerful treatments for complex diseases like genetic disorders and cancer. However, the manufacturing process is fraught with difficulties, including variations in cell characteristics and complex production methods. These challenges result in reduced efficiency, lower yields, and higher costs compared to traditional therapies.
The key to overcoming these hurdles lies in understanding and controlling critical process parameters (CPPs) and critical quality attributes (CQAs). PHCbi's LiCellGrow™ system steps in to address this need, offering a unique solution.
LiCellGrow™: A Game-Changer for CGT Manufacturing
LiCellGrow™ is equipped with cutting-edge In-Line monitoring technology, which continuously measures glucose and lactate concentrations, vital indicators of cell metabolism. This real-time data allows therapy developers to visualize metabolic changes and automatically adjust culture conditions accordingly. The system's precision is rooted in PHCbi's proprietary electrochemical measurement platform, honed over 30 years of blood glucose sensor development.
By providing a clear picture of cellular metabolism, traditionally a challenging task, LiCellGrow™ empowers developers to optimize culture conditions during manufacturing. This leads to improved cell quality, enhanced efficiency, and reduced costs by minimizing losses in CGT production.
Scaling Up CGT Production with Confidence
PHCbi's commitment to enhancing CGT manufacturing is evident in its Value Creation Plan 2027, which focuses on Diagnostics and Life Sciences. Building on the success of LiCellMo™ (*3), a research-only live cell metabolic analyzer, LiCellGrow™ takes CGT production to the next level.
The system's future enhancements include culture bags with filtration functions, pH/DO meters, and cGMP-compliant consumables, ensuring seamless scaling from research to commercial manufacturing. These features will be crucial for therapies like CAR-T cell therapy, where precise control and scalability are paramount.
Key Features that Set LiCellGrow™ Apart
Automated Control and Optimization: LiCellGrow™ employs In-Line monitoring technology to track culture conditions and cell status in real time. It automatically adjusts the medium based on metabolic data, ensuring an optimal culture environment. This aligns with the Quality by Design (QbD) concept, promoting scientifically robust and reproducible manufacturing.
Aseptic Conditions and Reproducibility: The system uses single-use culture bags, eliminating the need for manual sampling and reducing cross-contamination risks. It can be placed inside standard CO₂ incubators, making it accessible and cost-effective for laboratories. This design ensures aseptic conditions and highly reproducible cell culture.
A Step Forward for Advanced Therapies
Chikara Takauo, Director of PHC Corporation, emphasizes the significance of LiCellGrow™: "We believe LiCellGrow™ will empower therapy developers to tackle quality, cost, and delivery challenges in CGT. Building on our research-use system LiCellMo™, we're committed to making CGT manufacturing efficient, reliable, and scalable."
This announcement comes as PHCbi prepares to showcase LiCellGrow™ at the 25th Congress of the Japanese Society for Regenerative Medicine, a testament to its potential impact on the field.
Note: This technology is intended for research purposes and is not yet available for medical or clinical use in the United States, with an expected launch in summer 2026.
(*1) For more information on LiCellGrow™: LiCellGrow™ Product Page
(*2) Product availability: PHCbi Global Website
(*3) LiCellMo™: Live Cell Metabolic Analyzer
(*4) Quality by Design (QbD): An approach defined by the ICH guidelines, ensuring quality at the design stage.
What are your thoughts on this innovative technology? Do you think LiCellGrow™ will significantly impact the production of cell and gene therapies? Share your opinions and join the discussion!
