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

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.

STEP 01

Inspection of Tissue Samples

STEP 02

Culture Selection

STEP 03

Culture Testing

STEP 04

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 Culture Status
Cell Viability Record
Cell Viability Record
Cell Safety Testing
Cell Safety Testing
|
  • 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.

  • Research laboratory

  • Autoclave room

  • Cell culture room

  • Process monitoring Room

  • Completed product testing room

  • Material storage room

  • Operators access room

  • Central control room

  • Changing room

  • Product storage room

  • Raw materials (sample) testing room

  • 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.