Compliant with the Cell Processing Center manufacturing license. We ensure that all medical use cells are extracted from raw materials, cultured, tested, and cryopreserved in accordance with operating procedures. This ensures that cells are safe and viable, and differentiation control is stable.
Medical Research
Stem cells, inflammation, and immunotherapy
Medical research teams in Japan, Taiwan, and Germany have developed patented cell engineering technologies and continue to perform clinical research and develop anti-inflammatory products with major medical institutions.
Research Process
Cooperate with hospitals and clinics to conduct clinical case studies
Inspection of Tissue Samples
Culture Selection
Culture Testing
Storage Management
Center for Regenerative Medicine
Cell Medicine Research Department and Cell Function Research Office
Cell culture cleanroom operators need to have a professional degree (Ph.D.) in medical biotechnology from Japan. They have to exhibit cell culture knowledge and have at least 5 years' worth of clinical experience in this field. In terms of management, GMP and QMS are used as standards. In the development of regenerative medical products, the highest quality of safety control, personnel management, and the most ideal manufacturing environment is required.
Analysis Equipment - Quality and Safety Inspection
Cell Culture Status
Cell Viability Record
Cell Safety Testing
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Donor Screening -
Sample Test Items -
Safety and Toxicity Test -
Manufacturing Engineering Management -
Training and Equipment Management -
Performance Check -
Preservation Management System
Quality Control and Certificate of Quality
Cell Processing Center (CPC Facilities)
The company adopts GMP (Ministry of Health, Labour and Welfare Regulations, Quality standards stipulated by Good Manufacturing Practices) and all facilities meet soft and hard standards. The operation and management of all cell manufacturing research comply with these laws and regulations.
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Research laboratory
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Autoclave room
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Cell culture room
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Process monitoring Room
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Completed product testing room
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Material storage room
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Operators access room
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Central control room
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Changing room
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Product storage room
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Raw materials (sample) testing room
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Air conditioning and mechanical and electrical management room
| Name | Number of Cells | Cell Proliferation Number | Culture Area | Primary Cell Culture Cell Number |
|---|---|---|---|---|
| BIRE-AD | 1X105 | 4X106 | 4X106 | 5.6X108 |
| BIRE-UC | 2X105 | 8X106 | 4X106 | 2X109 |
CPC Culture Laboratory
This is a high-standard cell culture center that adopts the US Federal Standard Fed.Std.209D (target particle size 0.5μm) to ensure that the processing and culture process is of an equivalent standard to pharmaceutical grade.
10,000
The environment of the germ-free room is class 10,000.
1,000
The environment of the cell processing room is class 1,000.
100
The biological safety cabinet is class 100.
*US Federal Standard Fed.Std.209D (target particle size 0.5μm)
Our goal is to perform cell therapy research and manufacturing services for hospitals or medical research units. We aim for our clinical testing services to respond in a flexible and friendly manner and to provide efficient services to our clients.
