Toward the Launch of Haneda PDC:
Cell Resources Corporation's Strategic Move
Bringing the hope of regenerative medicine to all

The Alfresa Group has established its Medium- to Long-Term Vision with a target horizon of fiscal 2032, which sets forth a regenerative medicine supply chain as one of the Group's new businesses within its business strategy, and is promoting the expansion and transformation of its business portfolio. Cell Resources Corporation (hereinafter "Cell Resources"), which engages in the regenerative medicine-related business, is developing a system to provide comprehensive CDMO services^*1 through the supply of domestically produced master cells (cellular raw materials), the manufacture of autologous and allogeneic cell products, and the forming of partnerships with alliance partners in Japan and overseas. Cell Resources announced on March 3, 2025, that it would establish its new Haneda Process Development Center (PDC) to serve as a hub for the provision of CDMO services in the gene and cell therapy domain, with operations scheduled to commence in October 2025. Representative Director & President Kotaro Arita, who is leading Cell Resources as it commemorated its third anniversary in April 2025, joined colleagues in sharing their aspirations for regenerative medicine.

Reference: "Cell Resources Corporation to Establish New Process Development Center in Haneda for the Development of CDMO Services in the Gene and Cell Therapy Domain" announced on March 3, 2025pdf

*1 Contract Development and Manufacturing Organization (CDMO) services: Contract services ranging from the development of pharmaceutical manufacturing processes to clinical trials and commercial manufacturing

Why Academia and Industry Are Misaligned

Cell Resources President Arita highlighted the misalignment between academia and industry as the most pressing challenge in regenerative medicine. "iPS cell technology was first developed in Japan, but it is no exaggeration to say that Europe and the U.S. are a decade ahead in scaling up this technology for industrial use," Arita explained. "Japan relies heavily on manual processes in the development of standardized regenerative medicine products, in contrast to the widespread adoption of automation in Europe and the U.S. To accelerate the transition from laboratory research to real-world solutions, stronger collaboration between academia and industry is crucial. Process automation will be a key driver in ensuring the timely supply of efficient and high-quality products, ultimately enhancing competitiveness in the market." Cell Resources remains steadfast in its mission of "Bringing the hope of regenerative medicine to all," guided by a strong aspiration to drive innovation and growth in this vital industry.

Turning Aspirations into Action to Lead by Example at the Alfresa Group

President Arita began his career at Shikoku Alfresa Corporation and was later seconded to Alfresa Holdings Corporation, where he held a position in the Business Development Department. During his tenure, he developed expertise in new healthcare technologies, with a focus on regenerative medicine. He was appointed Representative Director & President of Cell Resources in November 2022. According to President Arita, his appointment stemmed from his decision—somewhat unexpected in such contexts—to step forward for the role. During his secondment to Alfresa Holdings Corporation, he contributed as a project member to the launch of Cell Resources. When discussions began on how the new company should be managed, he made the decision to step forward—motivated by his interest in the potential of regenerative medicine and a long-held desire to start a new business. He viewed this as a timely opportunity he could not afford to miss. He hoped to serve as a role model within the Alfresa Group by building a career path that reflected his own aspirations.

A Responsible Pharmacist Leaps into Regenerative Medicine

"I chose to become a pharmacist because I believe that life-saving drugs are invaluable. I sought to help ensure that innovative drugs, not yet available, could reach the patients who need them most," said Karen Arita, a member of the Corporate Planning Department at Cell Resources. Before making the leap into regenerative medicine, she had worked as a responsible pharmacist. She was drawn to this field because it shares the same purpose: using medicine to save patients' lives. Karen Arita identified the key challenges to scaling up regenerative medicine in Japan as a limited number of successful domestic examples and a shortage of trained professionals. To address these challenges, Cell Resources recognizes the need to acquire expertise from global companies while also developing its own human resources. Karen Arita is primarily responsible for forming alliances with several global companies. In the previous fiscal year, she played a leading role in forming an alliance with Thermo Fisher Scientific Inc. When asked about the English proficiency required for contract negotiations, she modestly downplayed her skills, noting that she was not particularly fluent. Nevertheless, she independently delivers presentations to European companies. Her consistent effort in attending online English classes twice a week has produced clear results.

Haneda PDC: Gateway to Global Pharmaceutical Collaboration

With the opening of its Haneda PDC, Cell Resources will operate three hubs across Japan. The Koriyama Cell Processing Center (CPC) serves as a master cell bank for mesenchymal stem cells, ensuring a stable supply of cellular raw materials, while the Tonomachi CPC functions as a Contract Manufacturing Organization (CMO) for Chimeric Antigen Receptor (CAR) T cell products. The Haneda PDC introduces a process development function that differentiates it from Cell Resources' other two hubs and underpins the expansion of the company's CDMO business. Furthermore, located in Haneda Innovation City near Haneda Airport, the site is ideally positioned to foster collaboration with targeted global companies through streamlined travel and transport. President Arita shared his vision for the future of Cell Resources, stating, "Our goal is to establish the Haneda PDC as a central hub for process development and to serve as a bridge connecting academia, which holds the drug discovery seeds, with pharmaceutical companies focused on scaling up, and venture companies engaged in pharmaceutical R&D."

Building Talent for Process Development at Cell Resources

Process development involves optimizing manufacturing processes through continuous experimentation, evaluation, and analysis to ensure product manufacturing. While essential to process development in regenerative medicine, even highly advanced and costly equipment is effective only when skilled personnel are available to operate it. Moreover, equipment is sourced from different manufacturers depending on the specific manufacturing process, with each requiring dedicated operational training. As part of its human resource development efforts for the launch of the Haneda PDC, Cell Resources is facilitating training sessions provided by equipment manufacturers.

Junpei Matsuzaki, who joined Cell Resources in 2023 as a mid-career hire and is currently with the Manufacturing Department at the Tonomachi CPC, is one of the personnel responsible for process development.

"During my time as a student, I developed a strong interest in cells while studying genetics, which guided my job search toward opportunities in cell-based therapies," Matsuzaki recalled. As he had hoped, his previous position at another company—with its own regenerative medicine pipeline—involved quality testing. However, operations were interrupted shortly before the company was poised to bring its products to market. Motivated by this frustration, he reflected, he joined Cell Resources, which offers opportunities to address the challenge of bringing products with consistent quality to market in the field of regenerative medicine. "My perspective changed after joining Cell Resources, as I was entrusted with a broader scope of responsibility. For example, in cell culture analysis, I now consider all possible factors, examining why a cell culture failed or why it succeeded. With this responsibility, I feel an obligation to contribute," Matsuzaki noted, his expression composed, though his words carried a firm sense of resolve.

"Putting on my scrubs helps me shift into the right mindset. It feels almost like a ritual." Matsuzaki never skips the routine of wearing them on important occasions. He is involved in analytical operations at the Tonomachi CPC, verifying whether the characteristics of manufactured cells meet the required standards through quality testing and other methods. In preparation for the full-scale launch of the Haneda PDC, Miltenyi Biotec B.V. & Co. KG—a manufacturer of equipment for the center—has completed the training, and process development efforts now well underway. "I recognize that equipment alone is insufficient to meet clients' requirements in both manufacturing and quality testing. This drives me to become an engineer capable of effectively addressing those needs." Matsuzaki conveyed his determination.

Process Development with Patient Delivery Focus

"Process development with a focus on patient delivery facilitate the scaling-up of industrialization for regenerative medicine," President Arita explained. His goal is to establish a comprehensive regenerative medicine supply chain service that manages the entire process—from sourcing cellular raw materials to executing deliveries to medical institutions—by integrating the total pharmaceutical and related product supply chains of Cell Resources and the Alfresa Group. Guided by the Alfresa Group's overarching principle of 'We create and deliver a fresh life for all," Cell Resources is pursuing its mission of "Bringing the hope of regenerative medicine to all" as it advances steadily toward the launch of the Haneda PDC through unified, company-wide efforts.

Notice: This document is a translation of the original Japanese document and is for reference purposes only. In the event of any discrepancy between this translated document and the original Japanese document, the latter shall prevail.