The Gene and Stem Cell Manufacturing Center of Hualien Tzu Chi Hospital has passed the inspection of the Taiwan Food and Drug Administration in 2022, and can officially provide bone marrow mesenchymal stem cells that meets the GTP standard under the special management regulations for the patient with spinal cord injury or degenerative arthritis treatment. As the only one cell preparation site (CPU) in eastern Taiwan that has passed the inspection, we hope to serve more medical institutions that have such medical needs but have not yet built a CPU in the future, and provide relevant application and implementation experience sharing.
Features / strengths
Currently, the Gene and Stem Cell Manufacturing Center of Hualien Tzu Chi Hospital uses the Cell Processing Isolator (CPi) for cell manufacturing. Compared with the generally CPU using the Biosafety Cabinet (BSC) system for cell processing, CPi has higher protection in terms of sterility and avoiding cross-contamination. Although the government does not require hospital units to fully comply with the PIC/S GMP standard, our hospital has required that all relevant management must comply with the PIC/S GMP standard in order to provide patients with a more stable level of treatment. Depending on the demand, consider further upgrading the current system to automated production to expand production capacity and maintain good quality management.
Specification in detail
bone marrow mesenchymal stem cell
5*107~2*108 cells per vial