Automating iPS Cell Manufacturing for Regenerative Medicine: Working Toward Truly Personalized Cell Therapies

The field of regenerative medicine and cell therapy keeps growing globally, transitioning from the research and development phase to real-world application. The global market for regenerative medicine is projected to grow from $35.5 billion in 2024 to $90 billion by 2030. Meanwhile, the complexity of cell manufacturing, high costs, and a shortage of skilled personnel remain challenges worldwide. To make personalized regenerative therapies available, technology capable of manufacturing cells—which vary from person to person—with consistent quality is essential. Precisely because it is highly personalized medicine, the entire process needs to have a high level of reproducibility and efficiency.

The Panasonic Group has been contributing to regenerative medicine by leveraging manufacturing expertise cultivated over many years. Combining that strength with biotechnology expertise, Panasonic Holdings (PHD) Technology Sector has developed technology that automates the process of establishing^*1 iPS cells (induced pluripotent stem cells) in collaboration with Kyoto University CiRA Foundation (iPS Cell Research Foundation). In April 2026, the project team began demonstration experiments at a laboratory of the CiRA Foundation’s “my iPS Project” at Nakanoshima Qross in Osaka, to develop an automated cell manufacturing system for establishing and culturing iPS cells derived from the blood cells of individual patients.

*1. iPS cell establishment: The process of generating iPS cells and establishing stable cell lines that can be continuously expanded and maintained. 

iPS cells serve as the starting point for generating various therapeutic cells, such as immune cells and those for cardiac muscle tissue. Because iPS cells can differentiate into a wide variety of cell types and can proliferate extensively, they play a key role in advancing regenerative medicine.

In particular, autologous cell therapy—which uses cells derived from individual patients—is attracting attention for its immunological compatibility and low risk of rejection. However, there are also inherent challenges and difficulties in generating cells tailored to each individual—or “custom-made” therapy. To address these challenges, the PHD Technology Sector has developed a prototype of the Automated iPSC (iPS Cell) Establishment System and has confirmed that iPS cells can be established from blood-derived cells using a fully automated system. The PHD Technology Sector is continuing its development and validation efforts for real-world application and commercialization of the system.

“The current iPS cell establishment process relies heavily on manual work by skilled technicians,” says Yoshihiro Owaki, Project Manager for the entire therapeutic cell manufacturing project. “Since cells are living organisms, quality variations can occur. There are also challenges, such as the need to maintain dedicated facilities and clean environments, as well as high manufacturing costs. To address these on-site challenges, the PHD Technology Sector is developing solutions for manufacturing therapeutic cells, including a fully automated system to complete the iPS cell establishment process.”

Currently, labor shortages are a serious challenge in pharmaceutical and healthcare settings. Owaki explains that for regenerative medicine to truly thrive, the field needs a reliable way to manufacture cells with uniform quality. Unless today’s specialized techniques can be converted into consistent, automated, machine-based processes, the long-term sustainability of this emerging field of medicine will be at risk.

The Panasonic Group is applying its accumulated technological expertise in the medical and biotechnology fields to respond to societal needs. Over the years, the Group has developed a broad range of medical and biotechnology related technologies—including blood glucose biosensors—while continuously honing its capabilities and know how in areas such as design of manufacturing equipment and process engineering. Currently, the PHD Technology Sector has identified “technologies that contribute to the lifelong health and well-being of every individual” as one of the key themes in its Technology Future Vision for 2040,^*2 and is promoting the development of solutions for therapeutic cell manufacturing as part of this initiative.

*2. Technology Future Vision: A framework that identifies the challenges facing society in daily life, sets out a vision for the ideal society in 2040 and outlines the direction of research and development undertaken by the PHD Technology Sector to turn the vision into reality.

The team’s first major hurdle was figuring out how to turn a hands-on, highly specialized iPS cell establishment process into something that machines could reliably perform. “Even a simple movement using equipment, like gently injecting culture medium using a pipette, requires minute adjustments and careful consideration,” says Naoshi Yamaguchi, the development leader responsible for automating the iPS cell establishment process under Owaki’s guidance. The team broke down the iPS cell establishment process into distinct individual steps—and then replaced each step with a corresponding machine process. Yamaguchi explains that the challenge was to reliably reproduce the subtle movements of skilled technicians by adjusting the injection speed, the diameter of the tubing and other parameters.

Owaki is responsible for setting the objectives and overall direction of the therapeutic cell manufacturing project. He explains that the team worked closely with the equipment design team to explore each individual step, including its nuances and subtleties, and conducted prototyping and verification to refine the design. The result was the prototype of the Automated iPSC Establishment System, developed and verified in a laboratory of the PHD Technology Sector.

Owaki adds that engineers with expertise in various fields, including cellular biology, machinery, and measurement, were brought together to advance the development effort. Although they shared a common goal, the terminology and underlying knowledge and expertise varied depending on their respective fields. Consequently, the team engaged in repeated discussions, carefully confirming, one by one, where misunderstandings lay and what was actually required as they proceeded with development. Sometimes, adjustments needed to be made on the equipment side. Other times, conditions had to be reevaluated on the biological side. The persistent dialogue between experts from different fields served as the driving force behind the development.

Yamaguchi, meanwhile, acted as a hub, helping bridge the gaps between experts in the biotechnology field who work with cells and engineers in the manufacturing field who focus on equipment design. He drew upon his experience in the fields of manufacturing and production technology for plasma displays and liquid crystal displays.

The result of these efforts is the Automated iPSC Establishment System. It establishes iPS cells through three processes—isolation, transduction, and culture—within a closed space known as a “closed system.”^*3

*3. Closed system: A mechanism in which cells and culture medium are processed within sealed containers or piping without being exposed to the outside air. Compared to an “open system,” where a person or robot opens the container to perform tasks, this system makes it easier to minimize the risk of bacterial or foreign matter contamination, contributing to stable cell generation in terms of quality and reduced workload.

Hematopoietic stem cells, which are primarily found in bone marrow, give rise to various blood cell lineages, including red blood cells, white blood cells, and platelets. Efficiently enriching hematopoietic stem cells from a patient’s blood could facilitate iPS cell generation.

In this system, the first step is the isolation of the hematopoietic stem cells from the blood (isolation process). Next, the four genes required for the generation of iPS cells are introduced into the hematopoietic stem cells (tranduction process). Viral vectors, which act as delivery vehicles carrying genes into cells, are used for this purpose. Returning cells to a pluripotent state in this way is called “reprogramming.”

The reprogrammed cells are then cultured inside the system and steadily multiplied as iPS cells (culture process). It takes approximately two to three weeks to establish iPS cells through these three processes: isolation, transduction, and culture.

The Automated iPSC Establishment System is unique in three main features. First, it employs a fully automated closed-system design. Since the establishment and culture of iPS cells are completed entirely inside a sealed container that is isolated from the external environment, this helps reduce the risk of contamination by microorganisms or foreign matter. This prevents variability caused by manual handling, ensuring reproducibility and consistent quality.

Second, it enables non-invasive sensing:^*4 the state of the cells can be monitored from outside the system during the culture process, without opening the culture vessel or exposing the culture environment to the outside. This avoids damaging the cells and further reduces the risk of contamination.

*4. Non-invasive sensing: Technology that measures and monitors biometric data using light, radio waves, or sound waves.

Third, iPS cells can be established from a small amount of an individual patient’s blood, roughly the amount collected during a routine blood draw. This minimizes the burden on the patient. Further, as the process requires only a small volume of blood, the use of expensive reagents is reduced, helping keep overall costs down.

Furthermore, the team designed the prototype as a compact, box-shaped unit smaller than a clean bench,^*5 making it easy to install at pharmaceutical companies, biotech companies, and cell banks.^*6 The device itself has been miniaturized to manufacture iPS cells for a single patient at low cost and configured to allow multiple units to operate at the same time as needed. The housing design, which fits easily into limited spaces, makes it easier to manufacture patient-specific iPS cells.

*5. Clean bench: An enclosed workbench maintained at a specific level of cleanliness to prevent contamination by dust and microorganisms
*6. Cell bank: A facility or organization that cryopreserves and supplies cells such as iPS cells and stem cells while maintaining quality control

Currently, manufacturing iPS cells for individual patients requires considerable expense. Owaki and his team aim to significantly reduce this cost through commercialization of this device. Replacing manual labor with the device not only reduces labor costs, but it also reduces hygiene management costs associated with maintaining a sterile environment, which had been essential in manual work settings.

However, the benefits extend beyond cost savings. Yamaguchi notes that stress reduction for the people working on cell manufacturing is another significant advantage. If technicians can shift from constantly working in high-pressure cleanrooms—where even the tiniest traces of bacteria are unacceptable—to monitoring the process on screens outside, their workload drops dramatically. That change not only eases stress and fatigue, but it also helps reduce human errors.

Using the prototype, the team successfully verified the automated process of establishing iPS cells from the blood of individual patients. The next challenge is to improve the quality and process reliability to a level where the iPS cells established by this device can eventually be used in cell therapies to treat patients. The device needs to be modified to meet the standards for cell manufacturing for clinical use and to ensure compliance with various laws and regulations.

As the next step toward commercialization, the PHD Technology Sector began demonstration experiments in April 2026 using the Automated iPSC Establishment System to establish and culture iPS cells derived from the blood of individual patients. The experiments are being conducted from April 2026 to March 2027 at a laboratory of the CiRA Foundation’s “my iPS Project” at Nakanoshima Qross in Osaka. Based on the results, the Technology Sector plans to proceed with the development of a commercial version of the system.

Primary target customers for the system will be pharmaceutical companies, biotech companies, and cell banks. As such, one of the key challenges is to design a system that is easy to use for people who are not developers or researchers, such as employees at pharmaceutical companies. The team is working to improve usability by making the touch panel interface intuitive and simplifying the process for loading and unloading culture samples.

Ensuring reliability is also essential. “The commercial product must be able to deliver the same quality 100 times out of 100,” says Owaki. “We will accelerate our development efforts to achieve this as quickly as possible.”

“If we succeed in commercialization, it may eventually become possible for local clinics to manufacture iPS cells and immune cells,” Yamaguchi says enthusiastically. “But first, we need to work steadily toward our next goal.”

During the verification phase using the prototype, news about the system spread within the industry—primarily among researchers, universities, and medical institutions—and this led to new cooperative relationships. The development of devices and automated processes for manufacturing therapeutic cells is now moving toward real-world application and commercialization. The Panasonic Group continues to contribute to the advancement of the regenerative medicine field by leveraging established cooperative relationships and expanding the ecosystem that supports iPS cell manufacturing.

Owaki emphasizes that the Panasonic Group alone cannot complete the entire process—from establishing iPS cells from blood to developing them into cell therapies and delivering them to patients. He says the ultimate goal is to expand alliances with partners, such as the CiRA Foundation, and form an ecosystem for iPS cell manufacturing and develop the initiative into a sustainable business.

Owaki continues, “Once regenerative medicine becomes truly widespread, manufacturing that depends on the craftsmanship of highly skilled specialists will reach its limits. We want the iPS cells our system manufactures to be utilized in clinical settings. We want regenerative medicine, long regarded as a technology of the future, to become common and within reach for many more people. The Panasonic Group will keep contributing to that goal through the power of manufacturing.”