EHL BIO Becomes South Korea’s First Certified Human Cell Management Business

A Major Step Toward Regenerative Medicine Standards

The certification of EHL BIO as a 'Human Cell Management Business' marks a significant milestone under South Korea's 'Act on Safety and Support for Advanced Regenerative Medicine and Advanced Biological Products.' This approval is not only a testament to technological readiness but also reflects a commitment to elevating safety and quality control standards across all stages—from collection and inspection to the high-level processing of stem cells and immune cells. By ensuring a systematic and transparent management process, clients can have full confidence in the safety of cell therapies intended for their future health restoration and quality of life according to EHL team assessments.

Furthermore, EHL BIO stands as the first entity in Korea to receive CPC (Cell Processing Center) authorization, proving specialized expertise recognized at the public health policy level. Operating under the stringent regulations of the Ministry of Food and Drug Safety (MFDS) allows for the efficient and reliable delivery of cutting-edge medical technologies into research and clinical processes.

Production Systems Under Class 100 GMP Standards

To support its role as an official cell management facility, EHL BIO has developed a state-of-the-art GMP (Good Manufacturing Practices) center equipped with high-level facilities, including Clean Rooms and Biological Safety Cabinets (BSC) for biosafety. Our production system is capable of culturing up to 6,000 lots per year within a Class 100 controlled environment, a high standard for biopharmaceutical production.

Having a solid infrastructure certified by regulatory authorities enables EHL BIO to effectively manage adipose-derived or urine-derived stem cells, as well as various immune cells such as NK Cells and T Cells. All cells are preserved using cryopreservation at -196°C to maintain cell viability and purity until they are utilized for health restoration goals according to EHL team assessments.

Becoming the first licensed human cell management business is our commitment to patient safety and quality of life.

Research and Development Collaboration for Excellence

Beyond cell management, EHL BIO focuses on expanding academic collaborations with leading medical institutions such as Chungnam National University Hospital, Dankook University Hospital, and Wonkwang University Hospital to conduct joint research in advanced regenerative medicine. These partnerships allow us to apply stem cell technology to health restoration goals for conditions such as chronic kidney disease, osteoarthritis, and neurological disorders.

With support from ministry-level regenerative medicine technology development projects, EHL BIO has advanced to clinical trials (IND) for several products, including ADSTEM for atopic dermatitis and KDSTEM for chronic kidney disease. All are produced under the licensed human cell management standards, positioning us to deliver new alternatives to patients through a network of over 150 partner hospitals according to EHL team assessments.

Standard Service Process at EHL Thailand

For those interested in receiving services from EHL BIO through EHL Thailand, we have a Thai coordination team ready to provide comprehensive care. The process begins with submitting an online consultation, followed by a medical team evaluating health documents and history to plan the trip to the EHL Cell Clinic in Apgujeong, Seoul.

Upon arrival in Korea, clients undergo health screenings and cell collection in a high-standard environment. The cells are then cultured in the approved GMP center and undergo strict quality checks before being administered according to the care plan. Continuous follow-up is provided after returning to Thailand to ensure health restoration goals and improved quality of life according to EHL team assessments.