Cell Processing Facility in Taiwan
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.