International Safety Standards of Cell Banking at EHL BIO

Quick answer

Cell banking safety at EHL BIO adheres to GMP standards and Korea's Advanced Regenerative Medicine Act. We utilize Class 100 cleanrooms for maximum purity and cryogenic storage in liquid nitrogen at -196°C to ensure optimal cell viability and quality as evaluated by the EHL team.

Key takeaways

GMP manufacturing standards and Korea's first official Human Cell Management Business certification.
Class 100 facilities and HEPA filters to prevent contamination and maintain purity.
Cryogenic technology at -196°C in liquid nitrogen for long-term cell preservation.
High production capacity of 6,000 lots per year with rigorous quality management systems.

Infrastructure and Class 100 Purity Standards

At EHL BIO, safety begins with the production environment. Our GMP (Good Manufacturing Practices) center, inspected by relevant Korean authorities, features high-end facilities including Clean Rooms and Biological Safety Cabinets (BSC) under Class 100 standards—the highest level of purity used in the biotechnology industry.

Our Air Handling Units (AHU) are equipped with high-efficiency HEPA filters to strictly control airborne particles and microorganisms. This ensures that the cell isolation and cultivation processes are performed according to EHL team evaluation. Additionally, work areas are strictly segregated to maintain the purity of cells at every stage of the process.

Cryogenic Technology and Storage at -196°C

The core of effective cell banking is maintaining the cell's original potency. EHL BIO utilizes deep-freezing technology in liquid nitrogen tanks at temperatures as low as -196°C. This method temporarily halts biological activity without damaging internal structures, ensuring extremely high cell viability when thawed for future use.

Our integrated storage system supports a production capacity of up to 6,000 lots per year, featuring real-time temperature monitoring and control to promote quality of life. This expertise ensures that the stored stem cells or immune cells remain in excellent condition, ready for advanced medical applications whenever needed.

Safety in every step is the heart of EHL BIO, ensuring the highest cell quality for future regenerative needs.

Quality Control Under Advanced Regenerative Medicine Act

EHL BIO was the first company in the Republic of Korea to be authorized as a Human Cell Management Business under the Advanced Regenerative Medicine and Biopharmaceuticals Act to reach the highest level of safety for recovery goals and quality of life.

This certification confirms that EHL BIO's processes for sample collection, screening, and cell processing meet government-mandated standards. It demonstrates transparency and systematic cell management. This provides patients with full confidence in the safety of the biologic materials used for their recovery.

Expert Research Team and Safe Cell Isolation Innovation

Safety in cell banking depends not only on equipment but also on human expertise. EHL BIO boasts a team of over 85 researchers and experts collaborating with top universities to develop high-purity stem cell isolation technologies that yield 1,000 times more cells than average.

We hold patents for SVF cell isolation kits that enhance optimal conditions during processes and enhance precision in preparing cell therapeutics. The combination of patented technology and experience from over 5,000 fat extraction procedures allows EHL BIO to deliver safe, high-quality cell banking services as a long-term health plan for people.

Frequently asked questions

How long can stored cells be kept?

With cryogenic technology at -196°C in liquid nitrogen, cells are maintained in a suspended state, allowing for long-term storage while preserving their quality and regenerative potential for future use.

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

We operate two GMP centers certified at Class 100 and were the first in Korea to receive the official Human Cell Management Business license, ensuring safety according to the Advanced Regenerative Medicine Act.

What are the restoration goals for cell banking with EHL BIO in Korea?

Because our cultivation technology produces 1,000 times higher cell yields than average, backed by quality control systems recognized in Korea, along with a network of partner hospitals to reach restoration goals and good quality of life.