At the scale-up/process optimization phase, our chemists further optimize the critical parameters to develop a viable commercial process. Cycle times, reactor loading and concentrations are optimized. The process can be frozen and the demonstration and validation runs are performed.

Our goal: To provide the client with a validated commercial process together with the associated regulatory documentation.

At a minimum you can anticipate the following outcomes as a result of your input combined with our activities:

Input

• Technical process
• Demonstrated pilot runs

Activities

• Cycle time reduction
• Reactor loading
• Maximize reagent concentration
• Yield improvements and product isolation improvement
• Demonstration and validation batches

Output

• Robust commercial process
• Fully validated process
• Drug master file/regulatory documentation