The “Cell Therapy Core Laboratory” (CTCL) of our hospital is built in compliance with the regulation of good tissue practices (GTP) for human cells and tissues announcement by the Ministry of Health and Welfare. The CTCL is one of the large-scale production sites of cell therapy clinical trial products (cells/tissues) in various medical centers in Taiwan. As a GTP laboratory, we provide a clean, safe environment for cell production, which ensures that patients receiving cell therapies won't contract infectious diseases. The CTCL is an important facility for cell processing of cell therapy clinical services in our hospital and CTCL provides support to the hospital's teams in achieving national plans or developing industry-university collaboration projects to advance domestic cell therapy clinical applications.

The "Cell Therapy Core Laboratory" is located on the south wing of the ninth floor of the Medical Science and Technology Building. The facility with a total area of about 325 square meters includes four Class 10,000 and two Class 100,000 positive-pressure clean rooms, as well as auxiliary areas such as quality control and cryopreservation. To maintain cleanliness, the air in the clean room is filtered by a high-efficiency filter (HEPA filter). The flow of personnel is planned for one-way entry and exit in the Class 10,000 clean rooms; the entry and exit of specimens, reagents, products, and waste are all through the passing box. All logistics have independent moving lines to reduce the possibility of cross-contamination. In addition, all important entrances and exits are equipped with access control devices, which can effectively control and record the entry and exit of personnel. All instruments are equipped with installation qualifications, operation qualifications, and performance qualifications. In addition to the basic equipment such as biological safety operation cabinets, carbon dioxide incubators, centrifuges, microscopes, and refrigerators/freezers, it is also equipped with the clinical-grade magnetic sorter (CliniMACS Plus) and the three-gas carbon dioxide incubator can meet the special needs of different planning processes. In addition, a central real-time monitoring system is set up to monitor the temperature, humidity, and pressure of the clean room, as well as the operation status of important instruments such as cell incubators, and refrigerators/freezers, and is connected to the central real-time monitoring system. If there is any abnormality, an alarm can be issued, and the staff will be notified to deal with it on the spot, and there are two sets of air-conditioning boxes that operate alternately and serve as backup for each other. In addition to complete hardware facilities, the laboratory is also equipped with a full-time professional management team. The establishment includes organizational structure and personnel management, laboratory borrowing, maintenance of laboratory facilities and equipment, laboratory environment cleaning and maintenance, specimen materials, reagents, products, various quality management systems for management, laboratory audit, document control, and complaint handling.

CTCL keeps improving the laboratory operations to provide a safe environment for the manufacture of cell therapy clinical trial products so that this core facility can guarantee the development of cell therapy products without any worries by users. CTCL has continuously accumulated the experience of assisting the cell therapy product development team, and through the interaction with the competent authority for each clinical trial application, understands and is familiar with the requirements of the competent authority for the development of cell therapy products, and then passes on these key requirements to inexperienced the cell therapy product development team also provides assistance in plan writing, application, and clean room facility specification consultation to increase the starting point of its product development, make its process planning more detailed, and reduce the administrative procedures required for subsequent clinical trial applications time. It is hoped that this cell therapy development platform can achieve the goal of "promoting talent cooperation, developing platform sharing, and establishing a quality management system" to promote the development of the domestic cell therapy field.

Welcome the teams who are interested in cell therapy to contact us. We will hold a meeting to introduce CTCL in detail.

Information:

Address: Medical Science & Technology Building 9F, No. 201, Sec. 2, Shipai Rd., Beitou Dist., Taipei City 112201, Taiwan (R.O.C.)

E-mail: ypyang3@vghtpe.gov.tw

Tel: (886-2)5568 8455