Park Sang-eon, Director of the CDMO Business Division at ENCell Co., Ltd., made these remarks in an interview with E-Daily at “BioJapan 2026,” recently held in Yokohama, Japan.
ENCell Co., Ltd., a company specializing in cell and gene therapies (CGT), is preparing the necessary procedures with local medical institutions to provide regenerative medicine services ahead of its entry into the Japanese regenerative medicine market. This is to establish a structure where local medical institutions handle procedures related to regenerative medicine provision plans, while ENCell manufactures and supplies cells at facilities compliant with South Korea’s Good Manufacturing Practice (GMP) standards. Having secured certification this year for a manufacturing facility for specific cell products in Japan and expanded its local partnership network to Nagoya and Osaka, the company’s next objectives are to secure its first contract manufacturing agreement and generate revenue from its regenerative medicine business in Japan.
Director Park stated, “We are currently reviewing the documents related to the regenerative medicine provision plan submitted by Japanese medical institutions. Once this process is finalized, we will sign contract manufacturing and quality agreements with the medical institutions and proceed to actual manufacturing after completing transport validation between South Korea and Japan.” He added, “At BioJapan, we aim to secure additional medical institutions and local partners that can lead to contract manufacturing agreements.”
Last May, ENCell Co., Ltd. received certification from Japan’s Ministry of Health, Labor and Welfare (MHLW) for its Hanam GMP Plant No. 2 as a manufacturing facility for specified cell processing products. This certification followed an on-site inspection conducted by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) in December of last year. This certification qualifies the company to handle cell culture and processing for the provision of regenerative medicine in Japan.
Japanese Regenerative Medicine: Cells Manufactured in Korea Following Procedures by Local Medical InstitutionsJapan’s
regenerative medicinesystem operates on a different track from general drug approvals. Medical
institutionssubmit data on target diseases and cells to the Regenerative Medicine Committee for review; based on this, they proceed with the necessary procedures through the Ministry of Health, Labor and Welfare before patient treatment can begin. ENCell Co., Ltd. is responsible for cell manufacturing, quality control, and supporting documentation, while local hospitals take the lead in patient care and submitting treatment plans.
Director Park explained, “While commercializing allogeneic cell therapies as drugs in Korea requires product approval from the Ministry of Food and Drug Safety, Japan’s regenerative medicine system operates under a separate, medical institution-centered procedure.” He added, “Once a medical institution completes the necessary procedures for providing regenerative medicine, it can offer treatment to local patients.”
ENCell Co., Ltd. first established a partnership with a medical institution in Nagoya earlier this year and has since expanded its network to include JK JAPAN, a Japanese company specializing in the distribution of cosmetics and medical devices, as well as the Jun Matsuyama Memorial Clinic in Osaka. ENCell Co., Ltd. is currently preparing documentation related to the regenerative medicine service plan with the Nagoya medical institution. With the Jun Matsuyama Memorial Clinic, ENCell Co., Ltd. plans to develop a regenerative medicine business utilizing autologous adipose-derived mesenchymal stem cells (MSCs).
“Since receiving certification, we have been receiving a steady stream of inquiries from medical institutions in Japan regarding contract manufacturing of stem cells,” he said. “At this year’s BioJapan event, we are also holding meetings with medical institutions and local partners interested in regenerative medicine to identify additional potential partners for contract manufacturing.”
Rather than completely renovating the facilities for Japanese certification, the Hanam GMP Plant No. 2 focused on demonstrating its existing quality management system. ENCell Co., Ltd. has already been producing cells and gene therapies for clinical trials following inspections by the Korean Ministry of Food and Drug Safety and global pharmaceutical companies. Although the PMDA inspection lasted two days, the company explained that there were almost no issues raised.
Director Park said, “Since we already had facilities and a quality management system in place for producing investigational medicinal products in accordance with domestic standards, there wasn’t much we had to set up from scratch aside from preparing documentation to meet Japanese regulatory requirements,” adding, “The fact that we passed an on-site inspection by a global regulatory agency is also significant for attracting overseas clients.”
Raising Margins with AAV and Building a Global CDMO NetworkENCell Co., Ltd. is also focusing on expanding its overseas customer base for CGT CDMO services alongside Japan’s regenerative medicine sector. The company’s core business rests on two pillars: cell and gene therapy CDMO services and the development of its proprietary new drug, “EN001.” Starting as a faculty-founded startup at Samsung Seoul Hospital, the company has been transforming cell therapies developed by researchers or biotech firms into drugs ready for actual patient administration at its GMP facilities.
CDMO goes a step beyond contract manufacturing (CMO)—which involves production based on a client’s established manufacturing process—by optimizing laboratory-scale processes for clinical and commercial production. In particular, with cell therapies, it is difficult to produce treatments for patient administration simply by scaling up the number of cells obtained in the laboratory. Culture media, time, collection and filling conditions, and quality testing methods must be re-tailored for each specific product.
Director Park stated, “Since each client possesses different core technologies and cell characteristics, it is difficult to apply a single standardized process across the board. We design processes by modularizing manufacturing stages—such as isolation, large-scale culture, harvesting, and filling—and combining them to suit the client’s specific technology.”
In particular, he noted, “GMP is a system where documentation is so critical that there’s even a saying calling it ‘Good Many Paper.’ By accumulating and systematizing manufacturing records, manufacturing instructions, and standard operating procedures (SOPs), we reduce response times from technology transfer through production, which translates into cost competitiveness for our clients.”
ENCell Co., Ltd. began with stem cell therapies and has expanded its production scope to include immune cell therapies, chimeric antigen receptor T cells (CAR-T), natural killer (NK) cells, exosomes, and viral vectors. Currently, Plant No. 1 at Samsung Seoul Hospital handles raw cell processing and the production of cell therapies without genetic modification, while Plant No. 2 in Hanam is equipped to handle viruses, enabling the production of cell therapies with genetic modification. Plant No. 3 in Hanam specializes in the production of viral vectors such as lentiviruses and adeno-associated viruses (AAV).
By linking these three plants, the company can carry out the entire process: isolating T cells from a patient’s blood, producing viral vectors to introduce genes, and finally manufacturing the cell therapy product. Executive Director Park emphasized this as a “one-stop production system that handles both cells and viruses.”
ENCell Co., Ltd. identifies AAV as an area with potential for future growth in unit price and profitability. AAV serves as a vector for delivering genes into the human body and is widely used in the development of gene therapies. According to the company, the manufacturing process, as well as analytical and quality testing, are more complex than those for cell therapies, and the costs required—from process development to production for clinical trials—are also significantly higher.
Director Park stated, “While CDMO projects for stem cell or non-genetically modified immune cell therapies may cost around 1 billion won depending on the client’s scope of work, a single AAV project can reach several billion won.” He added, “Conversely, given that this cost structure makes it difficult for early-stage biotech companies to commit, the domestic investment environment and the expansion of government-funded projects are crucial for increasing AAV orders.”
ENCell Co., Ltd. has internalized AAV process development since its inception. The company has refined its processes in collaboration with global equipment and raw material suppliers such as Sartorius, Thermo Fisher, and Polyplus, and based on this, it secured a contract for the Korea Research Institute of Bioscience and Biotechnology’s (KRIBB) customized AAV gene therapy development and production platform project. The AAV therapy in which the company participated in production recently received approval for an Investigational New Drug (IND) application and is preparing to enter clinical trials.
The company is also building a global CDMO partnership network. It is currently in discussions with Cell Lysosys in Japan, Cell Therapies in Australia, and Andelin Biosciences in the U.S. Regarding Andelin, the two companies are exploring ways to mutually support Korean biotech firms’ entry into the North American market and Andelin’s clients’ entry into the Asian clinical market.
He noted, “With rare genetic diseases, the number of patients is small, so recruiting clinical trial participants is crucial. Korea has the characteristic that most patients are concentrated in large hospitals, which can be an advantage for overseas companies conducting clinical trials in Asia.” He added, “Although the equipment and manufacturing environments vary across CDMO facilities, aligning documentation systems and test methods can make technology transfer and multinational clinical trials much smoother.”
ENCell Co., Ltd., which recently experienced a slump in performance, is pursuing diversification of its business portfolio through new ventures—such as regenerative medicine in Japan—alongside a recovery in CDMO orders that had declined due to clinical trial delays at its clients. ENCell Co., Ltd.’s primary clients are early-stage biotech companies conducting clinical trials through investment funding. However, the company explained that while follow-up production orders from clients were delayed due to a post-COVID-19 downturn in biotech investment sentiment and clinical trial delays caused by conflicts between the medical community and the government, signs of improvement are now emerging.
Director Park explained, “The typical structure is for clients to secure investment, proceed with production, produce clinical results, and then move on to the next investment round; however, orders declined as this chain of events weakened. Even when we secure an order, revenue isn’t recognized until we complete technology transfer, pilot production, full-scale production, shipment, or milestone achievement.” He added, “Orders have been recovering since last year, and the number of orders this year has increased compared to last year. Given that our business model requires us to grow alongside our clients, we expect earnings to rebound starting this year as clinical progress and fundraising improve,” he emphasized.
