GMP Manufacuring Facility

Spanning approximately 2,000 square meters, GenScript’s cGMP manufacturing facility is purpose-built to meet the stringent requirements of major global regulatory agencies, including the U.S. FDA, EMA, PMDA, and NMPA. The facility operates under a comprehensive GMP quality management system that encompasses raw materials, equipment and facilities, laboratory controls, production, packaging, and labeling. Equipped with advanced technologies and compliant cleanrooms, the plant follows standardized production processes and a robust sterility assurance system. GenScript offers end-to-end services to support preclinical, clinical, and commercial-stage programs—delivering high-quality, sterile products that meet global registration and manufacturing standards.