On June 20, 2025, PHC Group hosted an online roundtable discussion on the potential, challenges, and future outlook of CAR-T therapy in cancer treatment. This discussion featured Michael May, PhD, President & CEO of the Centre for Commercialization of Regenerative Medicine (CCRM), with two of our corporate officers.

1. The Current State of CAR-T Therapy: Overcoming Barriers to Adoption and Driving Technological Innovations

Nakamura:

Regenerative medicine including cell and gene therapy (CGT) is gaining significant attention as an innovative approach to treating diseases that have been difficult to treat, including cancer. CAR-T therapy, in particular, has been advancing rapidly. Michael, could you start by telling us about CCRM and your initiatives in the CGT and regenerative medicine fields?

May:

The Centre for Commercialization of Regenerative Medicine (CCRM) was established in Ontario, Canada, in 2011 with funding from the Government of Canada, the Province of Ontario, and leading academic and industry partners. Our mission is to bridge the gap between foundational research in regenerative medicine and its practical applications.
For regenerative medicine to become popularized, it’s essential to establish scalable and adaptable manufacturing processes. At CCRM, we oversee everything from process development to managing clinical-stage products. Our focus is on improving manufacturing efficiency and reducing costs.

Nakamura:

The popularization of regenerative medicine is indeed a global challenge. In Japan, innovative therapies in the CGT field, such as treatments employing iPS cells and the approval of CAR-T cell therapies like Kymriah^®, have already been in practical use. We expect the adoption of cell-based therapies to expand through technological innovation and cost reduction.

May:

Japan excels in regenerative medicine, particularly in research on treatments with iPS cells. Additionally, Japan’s industrial sector plays a significant role in the global commercialization of medical products, positioning the country at the forefront of regenerative medicine. At the same time, the U.S. continues to lead the way in the commercialization of these therapies, playing a key role in driving the industry forward. A prime example of the effectiveness of these therapies is in cancer treatment, especially CAR-T therapy. In the U.S., CAR-T therapy has achieved virtually curative results in some targeted blood cancers, which has served as a major proof point of its efficacy. The abundance of clinical data has fueled the rapid growth of the field, and these clinical results are a driving force behind the advancement of the industry.

Nakamura:

In Japan, CAR-T therapy still faces several challenges, such as the enormous manufacturing costs leading to high treatment expenses, the need to optimize manufacturing processes, and the challenge of ensuring access to treatment. What are your thoughts on these issues?

May:

Currently, CAR-T therapy is primarily focused on blood cancers, but further research and development are required for it to be effective against solid tumors, which make up the majority of cancers. Even for blood cancers, only a small percentage of patients in North America who need this treatment can receive it. One major reason is the extremely high cost of treatment even in the U.S. While CAR-T therapy may sometimes be covered by insurance in the U.S., it has not yet achieved adequate accessibility and adoption. The process itself, which involves extracting a patient’s cells, manufacturing the therapy, and reintroducing it into the patient’s body, is highly complex. To establish it as a standard treatment, specialized facilities are necessary. This means that, in addition to improving manufacturing processes, we need to develop facilities, infrastructure, and reimbursement systems that take into account the entire treatment journey for patients.
In Canada, CAR-T therapy has been approved under the public healthcare system, but like in the U.S., its adoption rate remains low. If, in the future, CAR-T therapy could be applied to all types of cancer and cure a large number of patients, it would undoubtedly have a profound impact on global healthcare. However, we need to fundamentally address the challenges of scalability and cost to achieve that vision.

Takauo:

In our industry, “scalability” is a key term, isn’t it? What kind of technological innovations do you think are necessary to address these challenges in the manufacturing field? Also, how do you think collaboration and partnerships with our company can help solve these issues?

May:

Even if scalability is achieved through automation, we still need to address challenges such as parallel processing of large volumes of patient samples and optimization of culture media. It is especially critical for autologous cell therapies, which employ a patient’s own cells and have unique characteristics for each individual. For these therapies, it is essential to evaluate product characteristics and automate and optimize the entire process to produce release through potency testing*. It also requires efficient processing in compact, clean environments while tackling additional challenges like reducing reagent and labor costs. At CCRM, we aim to address these issues and reduce costs by integrating characterization and process equipment.

* Potency testing: A test to measure and evaluate the efficacy and effectiveness of a pharmaceutical or therapeutic product. In the cell and gene therapy, it is conducted to confirm whether the product functions appropriately for its intended therapeutic purpose.

A fundamental element needed to promote the scalability of therapy is a combination of hardware-related technology and manufacturing capabilities, as well as expertise in regenerative medicine. In this regard, PHC is highly capable of providing everything from hardware design and manufacturing to logistics. Meanwhile, CCRM has the expertise to understand and utilize the biology of cell types, and conduct optimization studies to improve the conditions required by devices and cells in culture, growth, and purification. By working together, both companies can align and optimize workflows and processes, reduce costs, and elevate this complementary partnership to an industrial level. This collaboration is essential for advancing scalability.

Nakamura:

In February 2025, our company and CCRM signed a Master Collaboration Agreement to develop an expansion culture process for primary T cells. Through this collaboration, we aim to analyze various culture conditions using LiCellGrow™, PHC’s cell expansion system currently under development, and establish an optimized culture process for primary T cells. By combining the technologies and expertise of both of our organizations, we believe we can further advance manufacturing processes for cell-based therapeutics and cell culture technologies, contributing to the practical application of CGT.

May:

Absolutely. The technical collaboration between our companies is incredibly valuable. Incorporating advanced biosensors, such as in-line monitoring technology, into standard automated culture devices is extremely effective. Since autologous therapies use a patient’s own cells, which vary in characteristics from one patient to another, precise adjustments are essential for manufacturing.

2. Unlocking the Potential of Automated Culturing Technology Through In-Line Monitoring

Takauo:

Autologous CAR-T therapy is challenging for researchers when it comes to ensuring stability in quality and reproducibility. Moreover, the complexity of the manufacturing process, along with the significant time and cost involved, has led to soaring drug prices. To address these issues, we need technologies to monitor cell conditions in real time and optimize the culture environment. Automation of the cell culture process is also indispensable. PHC aims to standardize and enhance manufacturing efficiency by commercializing automated culture technology driven by monitoring data. PHC’s in-line monitoring technology, building on over 30 years of experience in blood glucose sensor development, enables monitoring of cell conditions in real time during the culture process. This technology supports the optimization of culture environments and helps ensure the production of high-quality cell products.

May:

We highly appreciate the potential value of PHC’s LiCellGrow™, incorporates essential features such as scalability and a cell expansion system furnished with in-line monitoring technology.

Takauo:

In the future, we believe that integrating in-line monitoring technology with AI will enable us to optimize the entire manufacturing process. This has the potential to further enhance the precision of cell growth forecasting, ultimately achieving greater stability and reproducibility in manufacturing.

3. Co-Creating the Future of Healthcare: A Collaborative Partnership Between CCRM and PHC

Nakamura:

As outlined in our Value Creation Plan 2027, Diagnostics & Life Sciences is a key strategic priority for PHC Group, with a strong emphasis on cancer diagnostics and treatments. Our collaboration with CCRM plays a vital role in achieving the objectives of this plan. Together, we are committed to advancing healthcare and discovering solutions to create a better future.

May:

Our partnership with PHC is an essential initiative to accelerate technological innovation in regenerative medicine. I am confident that our collaboration will enable us to deliver safe and effective treatments to more patients.

Takauo:

PHC’s precision technologies are indispensable in ensuring manufacturing reliability and quality in advanced cancer treatments, including CAR-T therapy. Moving forward, we will pursue the development of technologies relevant to various therapeutic approaches. Through collaborative research with CCRM, we aspire to make significant advancements in CGT and contribute to helping address challenges in cancer treatment.

About CCRM

CCRM is a global, public-private partnership headquartered in Canada. It has received funding from the Government of Canada, the Province of Ontario, and leading academic and industry partners. CCRM supports the development of regenerative medicines and associated enabling technologies, with a specific focus on cell and gene therapy. A network of researchers, leading companies, investors, and entrepreneurs, CCRM accelerates the translation of scientific discovery into new companies and marketable products for patients with specialized teams, dedicated funding, and unique infrastructure. In 2022, CCRM established OmniaBio Inc., a commercial-stage CDMO for manufacturing cell and gene therapies. CCRM is hosted by the University of Toronto.

Visit CCRM athttps://www.ccrm.ca/