Qualification Facilities
Innovative radiopharmaceutical R&D base with commercial production capacity in compliance with global cGMP standards and with Class A radiation safety certificate.
R&D and Production Base
Advanced R&D laboratory, research center for drug efficacy, pharmacokinetics and safety evaluation, Class A workplace
2,800 ㎡ R&D laboratory
Comprehensive research platform covering the development of biological, chemical, and radiolabeling processes and analytical methods
R&D laboratory: Class A workplace, available for the manipulation of nuclides F-18, Ga-68, Cu-64, Tc-99m, Lu-177, Y-90, Ra-223, Ac-225, Th-227, etc.
2,800 ㎡ GLP-like pre-clinical research center
Constructed and operated following the GLP standards
Animal experiments: drug molecule screening, pharmacodynamic studies, pharmacokinetic/toxicokinetic studies, safety evaluation
Pre-clinical research center: Available for the manipulation of nuclides F-18, Ga-68, Cu-64, I-124, I-123, Tc-99m, Lu-177, I-131, Y-90, Ra-223, Ac-225, Th-227, etc.
2,800 ㎡ Class A pilot workshop
Class A workplace: covering nuclides Lu-177, Ra-223, Ac-225, etc.
Shared-line production: C-Ray is available for immediate TT production for clinical supply with its existing production lines and capacity
10,000㎡ Class A R&D and production base
13 high-standard radiopharmaceutical production lines conforming to FDA, NMPA and EMA cGMP
Automated, intelligent and digitalized radiopharmaceutical production lines with proprietary intellectual property rights
Customized production line for advanced clinical supply and commercial production
Provincial key project, taking an area of 100 acres
Designed to meet the cGMP standards of FDA, EMA and NMPA
China’s first automated, intelligent, large-scale production line developed jointly and independently
