MIRAE BIO MEDICINE

Mirae Biogroup is

a biotechnology enterprise at the forefront of the world’s first stem cell and immune cell technologies, specializing in advanced cellular therapeutics research.

Mirae Biogroup is an institution officially licensed and recognized for its safety and highest quality cellular technology by Korea's Ministry of Food and Drug Safety and Japan's Ministry of Health, Labour and Welfare. It conducts comprehensive research in adult stem cells, immune cells, and anti-aging, and develops various cellular therapies.

The Cell Processing Facility (CPF) is a specialized facility that isolates, cultures, and stores cells such as stem cells and immune cells. It primarily cultures, manipulates, and processes living cells for medical use, aimed at patient treatment.

Mirae Biogroup's Cheongdam Center operates directly with medical and research staff, as well as clinical research professionals, adhering to international standards to ensure strict quality control supervision.

Mirae Biogroup GMP Research Laboratory

✔Cell Cultivation and Proliferation Cells harvested from patients are proliferated and manipulated to be processed according to therapeutic purposes.

✔Cell Manipulation Enhances cellular functions through processes such as genetic modification, differentiation induction, and purification.

✔Quality Control and Validation Manufactured in a sterile environment to prevent contamination, and quality tests are conducted to ensure safety and efficacy.

✔Storage and Transportation Cells are stored and transported to clinical sites while maintaining consistent temperature and environmental conditions

Key Facility Features

♦︎Clean Room A sterile space maintaining an aseptic condition, equipped with an air purification system and strict access procedures.

♦︎Cultivation Room Space for cell proliferation and cultivation, including incubators and culture medium preparation equipment

♦︎QC(Quality Control) Laboratory Laboratory for evaluating the quality and safety of cells.

♦︎Freezing/Storage Facility Ultra-low temperature freezers (below -196°C) and liquid nitrogen storage for cell preservation

The Rating of Mirae Biogroup’s Cell Processing Facility (Cleanliness Rating, Cleanroom Rating)

The Mirae Biogroup's Cell Processing Facility (CPF) is crucial for the manufacture and processing of cellular therapeutics, immune cell therapies, and gene therapies, necessitating the maintenance of a sterile environment.

The facility’s cleanliness is regulated according to GMP standards, operating cleanrooms ranging from Class 100 to Class 100,000.

USA Standard	European Standard	No. of Particles (≥0.5 µm, pcs/m³)	Application Example
Class 100	Grade A	≤ 3,520	laminar airflow workbenches and cell processing
Class 1,000	Grade B	≤ 35,200	sterile manufacturing labs
Class 10,000	Grade C	≤ 352,000	culturing, manipulation, and the manufacture of cell therapy products
Class 100,000	Grade D	≤ 3,520,000	general manufacturing zones and entryways

USA Standard

European Standard

No. of Particles (≥0.5 µm, pcs/m³)

Application Example

Class 100

Grade A

≤ 3,520

laminar airflow workbenches and cell processing

Class 1,000

Grade B

≤ 35,200

sterile manufacturing labs

Class 10,000

Grade C

≤ 352,000

culturing, manipulation, and the manufacture of cell therapy products

Class 100,000

Grade D

≤ 3,520,000

general manufacturing zones and entryways

♦︎Particle Count Standard Evaluate cleanliness by measuring the number of particles (≥0.5 µm) per cubic meter of air inside the cleanroom.

♦︎GMP Standards

       Grade A Areas where asepsis is essential (e.g., injection filling, cell infusion stages)
       Grade B Areas surrounding Grade A zones
       Grade C, D Cell handling and general manufacturing areas

Mirae Bio Group leads the world as the first in stem cell and immune cell technologies.