GTP Laboratory

Operation technology oriented to the quality of tissue cells.
The development of research on human cell tissue therapy assists in improving medical technology.
Clinical research and development in pursuit of excellence.

In response to the demand of cell product development, Retain Biotech uses Tai Chen Cell Therapy Center’s GTP clean room, which complies with the GTP regulations of the Ministry of Health and Welfare (Good Tissue Practice, 91. 12. 13, Department of Health Announcement No. 0910078677), and can provide cellular product development and production, quality control testing, etc.

GTP Laboratory Quality Policy:

  • Operation technology oriented to the quality of tissue cells.
  • The development of research on human cell tissue therapy assists in improving medical technology.
  • Clinical research and development in pursuit of excellence.

GTP Laboratory Features

  • Important instrument use alarm remote monitoring and management system
  • Automated manufacturing process of CAR-T cell products
  • System 24-hour monitoring
  • New Laboratory
  • Comfortable and independent process operation space

Services offered by GTP Laboratory

Clean Area

The establishment of a national standard clean area (ISO7 Class 10,000), five independent access control cell operation rooms, can support the cell production of Phase I and Phase II clinical trials. Each clean area is an independent air conditioner to avoid cross-contamination.

Customized Service

Cell product manufacturing process development and substituting, including pre-process testing, experimental and testing method validation, SOP establishment and writing, product substituting, etc.

Other services include the following:

GTP personnel education and training, temperature/humidity/pressure difference environmental monitoring data, instrument use and calibration records, consumable warehouse use permissions, static environmental microbial monitoring data, assistance in GTP verification services.