Continuous Flow Technology
The application of Continuous Flow Technology (CFT) for drug substance manufacturing compared to the use of traditional stirred batch type reactions is an example of the innovative approaches taken to process design that you can expect from Siegfried.
CFT offers advantages for:
- Improving the degree of purity achieved and/or higher process yield
- Avoiding ultra-low temperature process steps
- Simplifying process scale-up
- Achieving a higher process stability
- Enabling safe operation of reactions otherwise not possible in batch mode
The aforesaid advantages drove Siegfried to institute a laboratory program with the goal of implementing CFT technology at manufacturing scale in a cGMP pharmaceutical context. With the right process, CFT can provide improved levels of process control through Quality by Design (QbD) approaches, combining improved process economics versus batch operations.
Siegfried has successfully applied CFT at both lab and pilot levels for a variety of processes with several published case studies to illustrate the types of desired process improvements that can be achieved:
Our equipment inventory for CFT includes glass and metal equipment (nickel, hastelloy C22, & steel apparatus) as well as measurement and control equipment required for mass flow, pressure, temperature and reaction control (on-line Raman probe used).
In addition, CFT is well suited for evaluating a reaction's parameter space using statistical experimental design. In this area we apply Stavex®, a tool for software-supported experimental design.
If you need a fresh alternative look at how your process could be developed, Siegfried would be delighted to evaluate with you the benefits of Continuous Flow Technology. The prospects for improving standard batch processes may be much greater than you would expect.