Quick answer
EHL BIO utilizes Class 100 Clean Room technology and stringent environmental controls under GMP standards, featuring HEPA filtration and AHU systems to maintain a contaminant-free environment. As the first authorized Human Cell Management business in Korea, our facility supports a production capacity of 6,000 lots per year with high safety standards, according to EHL team assessment.
Key takeaways
- Class 100 standards for maximum purity during cell isolation and culture processes.
- High-efficiency HEPA Filter and Air Handling Unit (AHU) systems.
- Certified GMP facility and the first authorized Human Cell Management Business in Korea.
- Production capacity of 6,000 lots per year with integrated cryopreservation systems.
Class 100 and GMP Safety Standards
The core of regenerative medicine production lies in environmental control to ensure sterility. EHL BIO has established GMP (Good Manufacturing Practices) facilities featuring high-level Class 100 Clean Rooms, the standard for handling sensitive cells. This system is audited by Korean regulatory bodies to ensure every step, from adipose-derived stem cell isolation to immune cell cultivation, is conducted under peak safety conditions according to EHL team assessment.
Beyond cleanliness, EHL BIO is the first entity in Korea to be authorized as a Human Cell Management Business under the Advanced Regenerative Medicine and Advanced Biopharmaceuticals Act. This authorization elevates quality control for cell collection, inspection, and processing, ensuring systematic transparency and supporting that the cells meet purity and quality standards for clinical use.
Innovative Air Control and HEPA Filtration Systems
To achieve high cell viability and consistent quality, EHL BIO integrates sophisticated Air Handling Units (AHU) with High-Efficiency Particulate Air (HEPA) filters to trap microscopic particles and potential airborne contaminants. This system maintains optimal air pressure, temperature, and humidity for cell growth. The use of advanced Biological Safety Cabinets (BSC) further protects both the cells and laboratory personnel during the production process.
These technologies support a production capacity of 6,000 lots annually. Strict environmental monitoring extends to the use of modern inverted microscopes and CO2 incubators to closely track cell development in conditions mimicking the human body. This allows EHL BIO to deliver cell therapy products with goals of tissue regeneration and repair according to EHL team assessment.
Our Class 100 Clean Room technology is the cornerstone that allows EHL BIO to culture high-quality cells while ensuring superior safety according to EHL team assessment.
Cryopreservation Systems at -196 Degrees Celsius
Beyond clean room cultivation, environmental control extends to long-term cell storage. EHL BIO utilizes liquid nitrogen storage tanks for cryopreservation at temperatures as low as -196 degrees Celsius, effectively halting biological activity without damaging internal structures. This freezing technology allows clients to store their own cells for future use, maintaining the potency and recovery goals as the day they were collected.
This storage system is vital for individuals planning for long-term health (Aging Well), as collecting cells while the body is healthy ensures higher quality samples for future support of quality of life from degenerative conditions. EHL BIO’s expert team rigorously manages these quality control and storage systems according to international standards.
Production Expansion and Partner Networks
Success in clean room technology and GMP-compliant production has enabled EHL BIO to expand its Cell Center network, including establishing services in Thailand through EHL Thailand for integrated coordination. We collaborate with over 100 partner hospitals in Korea to deliver high-safety medical innovations according to EHL team assessment.
Our operations extend beyond cell production to the development of products like Exosomes and Conditioned Media, which are registered with International Nomenclature Cosmetic Ingredient (INCI) names and certified by Korean safety standards. All these processes undergo the same rigorous clean room environmental controls to ensure the quality and recovery goals of regenerative medicine in all its forms.
Frequently asked questions
What are the goals for recovery and quality of life in cell therapy?
The primary goal is to use cell technology to restore physical conditions and improve quality of life, focusing on cells cultured under Class 100 standards for optimal recovery potential according to EHL team assessment.
What is the Class 100 Clean Room standard?
It is an international standard for controlling airborne particulate matter to a minimum, ensuring a truly pure environment for production and cell therapies.
Why is the GMP standard necessary for cell production?
GMP (Good Manufacturing Practices) standards maintain consistent production quality, prevent errors, and support the safety of products intended for human use.
How long can cryopreservation maintain cell quality?
Cryopreservation at -196 degrees Celsius can pause cell aging for many years, preserving the cell's ability to proliferate and reach tissue recovery goals when needed for future use.
Related conditions
Based on EHL BIO information: EHL BIO · EHL BIO · EHL BIO · EHL BIO. Each care plan follows an individual EHL assessment.
