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High Potency Drug Development

Sundia understands the importance of oncology drugs to the pharmaceutical industry and has built up a high potency drug development platform to provide this special service to our clients. The design of all relevant laboratories, scaling up kilo lab and pilot plant strictly follows the ESH guidelines and satisfies the stringent quality assurance and regulatory affair requirement.
• In full compliance of ICH Q7A guidelines
• Meet all the cGMP requirements
• SOPs
• Personnel training
• EHS consideration
• Operation in isolated area
• PPE: Safety Glasses or Goggles, Disposable Lab Coat, Double Gloves, Respiratory Protection
• Isolation equipment and systems required to protect our employees from the APIs
• Waste handling
• Cleaning and decontamination

Major Facilities and Equipment
− Kilo Lab for API
• Located in Shanghai 
• Total area: 4000 sq. ft.
• Clean room for API manufacturing
• 12 reactors, 50L – 200L
• Operation temperature: -80 C° to 230C°
• Up to 10kg API

− Pilot Plant in Taicang
• 20 reactors, 300L-5000L (Phase I)
• Operation temperature: -80 C° to 230C°
• 2 hydrogenation reactors, 500L and 1000L
• QA/QC labs, HPLC and GC
• Use-Test Labs

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