Sterile Clinical Trial Material Formulation & Filling

Whether a project is in post discovery, cGMP phases I-II, or ready for commercial manufacturing, DSM can provide all the resources necessary to provide assured delivery.

Sterile CTM Suite

• Phase I-II clinical trials
• Phase III CTM supply continues on commercial lines
• Lyophilization cycle development
• 24 sq. ft. Hull freeze dryer (4 shelves)
• Up to 4,000 vials/Lyophilized batch
• Up to 11,000 vials/Liquid batch
• Semi-automatic filler with peristaltic pump for dose control (maximum 60 upm)
• Vial sizes from 3cc to 30cc
• Cozzoli vial washer
• Ready to Sterilize or Valex Stopper Preparation