By Dr. Ingo Klement, Director Global Business Development for Exclusive Synthesis, Evonik
Momentum continues to build behind the use of flow chemistry to overcome many of the process limitations of batch manufacturing for APIs and advanced intermediates. Thanks to more than two decades of collaboration between manufacturers, academia and regulatory authorities, the foundation stones have been laid to integrate flow chemistry into the process development and cGMP manufacturing of such substances made by chemical synthesis.
Several drug products utilizing continuous processes have now been approved by the FDA, with many more in the clinical development pipeline. On the drug substance side however, despite much progress, there are still very few companies that have been able to successfully scale-up an API or intermediate with one or more continuous chemical process steps beyond the kilogram range under cGMP conditions. There are multiple factors behind this lack of commercial progress.