6,000 Lots Annual Capacity: EHL BIO's World-Class GMP Production Standards

Quick answer

EHL BIO possesses a robust production capacity of 6,000 lots per year through two MFDS-certified GMP facilities. These centers utilize proprietary technology capable of yielding cell counts up to 1,000 times higher than competitors while maintaining high viability rates for global medical demands.

Key takeaways

Maximum capacity of 6,000 lots per year, supporting treatments in Korea and global networks.
Class 100 cleanliness standards featuring HEPA Filters and AHU systems.
First institution in South Korea certified as a Human Cell Management Business by the MFDS.
Cryopreservation technology in liquid nitrogen at -196°C to maintain peak cell quality.

World-Class GMP Production Hub

EHL BIO prioritizes quality and safety at every production stage through its two dedicated GMP (Good Manufacturing Practices) facilities designed for mass cell cultivation. The first center was completed in 2015 and passed MFDS inspection in 2016, followed by the second facility in 2019. This advanced infrastructure allows EHL BIO to maintain a production capacity of 6,000 lots per year, positioning the company at the forefront of the biotechnology industry.

The core of this capacity lies in specialized expertise in separating and culturing stem cells derived from adipose tissue and urine. EHL BIO's proprietary technology yields cell counts up to 1,000 times higher than industry competitors while maintaining excellent cell viability and quality. This ensures that every produced cell therapy provides maximum regenerative potential, adhering to personalized treatment plans designed by an expert team of doctors and scientists.

Class 100 Cleanliness and Quality Control

Cell therapy safety begins with a contamination-free environment. EHL BIO utilizes Class 100 Clean Room systems, strictly controlled by high-efficiency HEPA filters and Air Handling Units (AHU) to maintain the highest standards. The facility is equipped with advanced tools, including Biological Safety Cabinets (BSC) for biosafety and CO2 incubators that maintain the optimal environment for cell growth.

Operating under the Advanced Regenerative Bio Act, EHL BIO was the first in South Korea to be certified as a 'Human Cell Management Business.' This certification covers the entire process from collection and quality testing to processing. This international-standard management system ensures that every product is consistent and safe for actual therapeutic use in treating various conditions, ranging from age-related degeneration to complex chronic diseases.

Class 100 GMP standards and a capacity of 6,000 lots per year affirm EHL BIO's readiness as a global leader in regenerative medicine.

Innovative High-Efficiency Cryopreservation

Beyond efficient cultivation, EHL BIO excels in long-term cell storage technology through a high-quality cryopreservation system. Stem cells and immune cells are preserved in liquid nitrogen tanks at -196°C, a temperature that halts cellular activity at its peak without losing regenerative potential. This technology allows patients to undergo a single collection and utilize the cultured cells for multiple treatments throughout their lives.

This mass cultivation system supports a wide range of therapies, from skin rejuvenation using Exosomes and Conditioned Media to treating challenging conditions like chronic kidney disease and osteoarthritis. The high production capacity reduces patient waiting times and facilitates faster, more efficient access to regenerative medicine innovations, all managed by a research team of over 85 dedicated professionals.

Collaboration Network and Future Opportunities

A production capacity of 6,000 lots per year does more than support local patients; it connects to a network of over 100 partner hospitals in Korea and 50+ international locations. This includes research collaborations with top institutions like Chungnam National University and Yonsei University to develop advanced regenerative medicine technologies.

EHL BIO's selection by the Korean Fund for Regenerative Medicine (KFRM) for chronic kidney disease and atopic dermatitis research validates the government's confidence in the company's production and research standards. We are committed to utilizing high-purity cell cultivation and patented innovations, such as SVF separation kits and 15-PGDH inhibitors, to enhance human quality of life and promote a healthier, longer lifespan in the future.

Frequently asked questions

How does EHL BIO's GMP standard differ from others?

EHL BIO features facilities with the highest Class 100 standards and was the first in Korea authorized as a Human Cell Management Business. It employs strict AHU and HEPA filter systems with a high capacity of 6,000 lots annually.

Does mass cell cultivation affect quality?

No. On the contrary, EHL BIO's technology yields 1,000 times more cells than average while maintaining excellent purity and viability through rigorous quality control at every step.

How are the produced cells stored?

Cells are stored using cryopreservation technology in liquid nitrogen at -196°C to preserve their state and quality for future patient needs.