BioJapan 2025 Sponsored Seminar Report (October 8)
“Accelerating Cell Therapy Manufacturing: Strategies from Preclinical Research to Early-Stage Production”

Exploring the Current State and Challenges in Cell Therapy Development,
and How Japan Can Leverage Its Unique Strengths

BioJapan 2025, one of Asia’s largest partnering events in the life sciences sector, was held over three days from October 8 to 10 at Pacifico Yokohama. On the opening day, iPark Institute Co., Ltd., which operates Shonan Health Innovation Park (hereafter “Shonan iPark”), hosted a sponsored seminar titled “Accelerating Cell Therapy Manufacturing: Strategies from Preclinical Research to Early-Stage Production.” Four experts from Japan and overseas joined the panel to exchange views on the current status, challenges, and future prospects of cell therapy development.

Photo (from left): Daniel Kemp, Hiroto Bando, John Kelly, Toshio Fujimoto

Panelists (titles omitted):
-(Moderator)Toshio Fujimoto, President and CEO, iPark Institute Co., Ltd.
-Daniel Kemp, Chief Executive Officer, Shinobi Therapeutics
-Hiroto Bando, President, Minaris Advanced Therapies Japan
-John Kelly, Cell and Gene Therapy Catapult

New Cell Processing Center to Open in Shonan iPark
iPark Institute Co., Ltd. will open a rental-type Cell Processing Center (CPC) at Shonan iPark in collaboration with Minaris Advanced Therapies and Hitachi Global Life Solutions. The new facility, scheduled to open in November 2025, will be available for use by startups and other research entities. This new option enables startups to manufacture clinical trial materials using shared rental facilities, in addition to the conventional models of in-house production or outsourcing to a contract manufacturer.

Current Trends in Cell Therapy Development
Globally, more than 24,000 drug candidates are in development, with about half belonging to new modalities – of which roughly half are cell and gene therapies. The U.S. currently leads the field, followed by China, Europe, and Japan. While China focuses primarily on CAR-T therapies targeting malignant tumors, Japan has emphasized cell and tissue transplantation.

This seminar focused on the critical transition from preclinical research to early-stage clinical development, a phase where many startups face major challenges. Many startups struggle during this transition. Manufacturing becomes essential, but it’s often outside their expertise. Today’s session brings together leading industry figures to discuss how to navigate this difficult stage.
— Toshio Fujimoto, iPark Institute

Speaker Introductions
Shinobi Therapeutics
A company challenging the development of groundbreaking cell therapies that combine iPS cell and CAR-T technologies. With about 60 employees across offices in the U.S. and Japan (Shonan iPark and Kyoto University), the company plans to initiate trials in Japan. Its development pipeline includes candidates targeting solid tumors and autoimmune diseases to begin first-in-human dosing trials by the end of next year.
— Daniel Kemp

Minaris Advanced Therapies
A CDMO specializing in regenerative medicine and advanced therapy products, Minaris supports biotech companies from preclinical development through to commercial manufacturing. At the new rental CPC in Shonan iPark, Minaris provides quality assurance services. These include support for quality management systems, equipment maintenance, and staffing of operators and QC analysts, fully accompanying companies with no prior manufacturing knowledge or experience.
— Hiroto Bando

Cell and Gene Therapy Catapult (UK)
A UK-based, government-backed organization established to advance cell and gene therapies. Cell and Gene Therapy Catapult provides both financial and non-financial support to startups, including consulting and venture capital engagement. The organization also promotes equitable global access by reducing manufacturing costs, and in 2024 launched a new testbed for manufacturing automation.
— John Kelly

Panel Discussion I – Challenges in Cell Therapy Development
Cost and Scalability
“Over 10,000 CAR-T treatments are produced worldwide each year, but the estimated number of eligible patients exceeds 80,000. This means about 70,000 patients still lack access. The issue lies not only in cost but also in production capacity. As indications expand, disparities will widen. We must address scalability and cost immediately.”
— John Kelly

The Early Stages of Cell Therapy Development are crucial
The beginning is crucial in cell therapy development: Manufacturing is a significant challenge. For the scale of a first-in-human trial, with only 3 or 5 treatment cases, manufacturing is relatively straightforward. However, commercial production requires volumes of 1,000 or even 10,000 doses. Moreover, altering the manufacturing process later in cell therapy development is difficult, requiring a robust production system to be envisioned early on. This is where CDMOs like ours can be of value.
— Hiroto Bando

Funding is also a critical issue
The biggest challenge for biotechs in the cell therapy space is securing funding. This problem is particularly pronounced in Japan, where the amounts available are also smaller. Several startups with promising candidates failed to reach clinical stages due to lack of funds. Furthermore, when one fails in development, investors become more convinced that “investing in cell therapy development won’t yield returns,” making fundraising even harder.
— Daniel Kemp

Panel Discussion II – Overcoming Challenges
Persuading with Technical Excellence
When raising funds from investors, we demonstrate the excellence of our technology. Specifically, we show that with sufficient funding, we can initiate human clinical trials for our two current drug candidates. We convince investors that successful development will yield a high-value cell therapy with superior efficacy and safety, and that the future revenue potential of this product is substantial.
— Daniel Kemp

Early-stage Preparation is Crucial
At the early stages of startups, the necessary costs can be kept to a minimum. Once development advances, if manufacturing issues arise, forcing a complete reevaluation and redesign of the manufacturing process from the beginning, many biotech companies cannot sustain their operations. This is not because the product is flawed, but because the initial plan was problematic.
At Catapult, we provide the necessary information and various forms of support to entrepreneurs even before they launch their biotech companies.
— John Kelly

Panel Discussion III – Japan’s Unique Strengths
Unique Approval Systems and Meticulous National Character
Japan’s strengths against overseas competitors include unique review systems, such as the Sakigake Designation and the Conditional and Time-limited Approval System. Additionally, the distinctive Japanese character—being extremely meticulous and strictly adhering to instructions—is also considered a strength. Furthermore, it’s crucial to think more broadly, such as leveraging the weak yen/strong dollar exchange rate to manufacture products in Japan for supply to the US market.
— Hiroto Bando

World Leader in iPS Cell Technology
One of Japan’s strengths is the depth of researchers in iPS cell research. Talented individuals, regardless of industry or academia, have gathered in this field, particularly in regenerative medicine and malignant tumor research. I’ve worked with iPS cell therapy companies worldwide, and I’ve never encountered researchers as skilled as Japanese scientists. I believe Japan has every potential to become the global hub for iPS-based drug innovation.
— Daniel Kemp

Japan is also undergoing significant change
In the UK, university professors used to be at the center of entrepreneurship, but now young postdocs are fearlessly taking risks to start companies. A similar shift is happening in Japan. Japan’s traditional “risk-averse culture” and resistance to entrepreneurship are becoming a thing of the past. Among young Japanese researchers, there is a growing willingness to take risks and challenge themselves to start businesses. I think this is a very positive change.
— John Kelly

Panel Discussion IV – The Future of Cell Therapies
Improving Manufacturing Costs as Top Priority
As a CDMO, we consider reducing manufacturing costs our foremost challenge. Five years into this business, our Yokohama manufacturing site has achieved significant cost reductions. However, cost reduction has its limits, so we are also tackling more advanced production technologies—such as automated cell production and closed systems approaches for higher reproducibility. Improving manufacturing costs is our current priority.
— Hiroto Bando

They will eventually return
It is true that some big pharma companies, facing challenges like expiring patents on their own products, have decided to withdraw from cell therapies—which take longer to develop than conventional drugs and present many manufacturing challenges. However, I am confident that once cell therapy manufacturing technologies are established, robust production systems are realized, and iPS cell therapies are successfully commercialized within the next decade, they will return to this field.
— Daniel Kemp

The mainstream of future treatment
I agree with the opinion that Big Pharma will eventually return to the world of cell-based therapeutics. As profit-driven entities, they sometimes have no choice but to prioritize short-term gains. But they possess the capital to acquire entire biotech companies outright. Thirty years ago, Big Pharma dismissed monoclonal antibodies as “difficult to manufacture.” Cell-based therapeutics should also become the mainstream of future treatment.
—John Kelly