10,000 ㎡ Automated, Intelligent, and Digital Grade A Production Site
Service Content
• 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
CDMO Cooperation Method
Pharmaceutical Research
● Radiolabeling pre-experiment
● Process development and optimization
● Analytical method development
● Compatibility studies of raw materials, excipients and packaging materials
TT can be carried out immediately to achieve clinical product supply with current production line and capacity
● Cost controllable, light asset operation
● Flexible and convenient
● High standard delivery
● Suitable for non-clinical sample production and clinical product supply
Shared Production Line
Customized production line according to client demand
● Plan ahead to lock in production capacity
● Flexible customization, designed according to client demand
● Automated, intelligent, and large-scale production can be realized
● Suitable for late-stage clinical product supply and commercial product production
Dedicated Production Line
● Analytical method transfer
● Process Transfer
● Improvement of production line applicability
Technology Transfer
● Process Validation
● Methodology Validation
● Stability study
Process Validation
● Packaging and transportation of radioactive samples
● Supply of non-clinical samples
● Supply of clinical samples
● Supply of commercial pharmaceuticals
Product Supply
