Medigen-GDT-TW-V210-sub-1080p.mp4_20201113_112711.563[870x320]

Good Tissue Practices (GTP) and Good Manufacturing Practices (GMP) are the core TFDA requirements for manufacturing products regulated as Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps) and cellular therapies. Based on GTP/GMP, MBC has constructed new state-of-the-art cell processing units and quality control laboratory that meet the international ISO standards. We also have a strict management and monitoring system for our hardware facilities, staff training, material quality and production process. The cell culture laboratory complies with ISO Class 7 (Class 10,000) standard, meaning that the cleanroom has at most 1 x 107 particles per m³ of air. The entire process of cell culture follows standard operating procedures, ensuring safety, stability, completeness and effectiveness of relevant staff, environment and cellular products.