Han Family Nursing Hospital and NKCL Bio Group have begun building an integrated platform encompassing advanced regenerative medicine clinical research and cell therapy manufacturing processes.

Han Family Nursing Hospital [Jeonil Medical Foundation (Chairman Kim Da-mi), Hospital Director Dr. Jeon Se-il] and NKCL Bio Group (Chairman Shin Dong-hwa) held an agreement ceremony in the conference room on the 5th floor of Han Family Nursing Hospital on the 1st and formalized the establishment of an integrated advanced regenerative medicine clinical and manufacturing system.

This cooperation is a process to externally confirm joint projects already in progress based on pre-signed contracts. The two organizations immediately launched a joint project covering the entire cell therapy development cycle and shared implementation plans and a mid- to long-term roadmap.

The key is to tie the entire process of research and development, clinical practice, manufacturing, and quality control into one system by directly linking the clinical infrastructure with the Ministry of Food and Drug Safety’s GMP-certified cell processing facility. Through this, the plan is to build a standardization system at a level that can be operated in practice.

In particular, a model that combines clinical infrastructure and GMP manufacturing facilities is a rare example in Korea. It is regarded as meaningful in that it has a structure that can quickly connect research results to actual treatments and promote commercialization together.

Han Family Nursing Hospital has the capability to conduct clinical research on advanced regenerative medicine based on clinical experience and data accumulated in geriatric diseases, chronic degenerative diseases, rehabilitation treatment, and bedsore treatment. It has also established a research foundation with ethics and safety through the operation of an IRB (Institutional Review Board) and a clinical trial management system.

NKCL Bio Group is a bio company that has established culture, separation, cryopreservation technology, and a quality evaluation system for natural killer cells (NK Cells) and stem cells based on GMP-certified cell processing facilities. By applying an automated cell culture system and real-time quality monitoring technology to the production process, reproducibility and commercialization scalability are secured.

The company is also establishing its own production (Point-of-Care) system within the hospital by introducing the four-person automatic cell culture machine “ACS-II” to its GMP manufacturing facility. Through this, it has laid the foundation for producing and applying patient-tailored cell therapy directly within medical institutions.

Based on its closed structure, “ACS-II” lowers the risk of contamination by performing the entire process from culture medium injection to cell collection in a disposable kit isolated from the external environment. It is also characterized by a deep learning-based AI real-time monitoring function that analyzes cell density, activity, and shape 24 hours a day, and automatically controls the culture environment such as temperature, CO₂, and pH.

Additionally, each of the four culture chambers can be operated independently, allowing different culture protocols to be applied simultaneously for each patient. All cultivation processes are designed to enable data management and quality tracking in accordance with GMP standards through the Audit Trail function, which is automatically recorded.

Through this collaboration, the two organizations plan to design and perform clinical research on advanced regenerative medicine, advance cell processing facilities and standardize CMC-based manufacturing processes, jointly apply for core technology patents and secure intellectual property rights, establish a real-time collection and analysis system for clinical data based on EDC and CTMS, establish a clinical and quality control system that meets ICH-GCP standards, and expand joint academic research and domestic and international academic presentations.

Hospital Director Jeon Se-il said, “This collaboration goes beyond a simple research agreement and is an actionable model that directly connects data obtained from clinical sites to the development and production of actual treatments.” He added, “Concrete projects are already in operation, and we plan to quickly produce visible clinical and manufacturing results.”

Chairman Shin Dong-hwa said, “We are building a cell therapy production system that can be applied immediately by integrating the clinical and manufacturing capabilities of both organizations,” and added, “Based on this, we will gradually expand the development of treatments with high commercialization potential.”

The two organizations plan to sequentially apply the integrated system being built this time to the fields of cancer, degenerative diseases, and intractable wound treatment, and gradually expand clinical and commercialization results.