Flow chemistry for more sustainable API manufacturing
Axel Zimmermann, director of process development services, pharma services, at Thermo Fisher Scientific, looks at how introducing flow early can reduce costs and time
Early clinical supply is often based on medicinal chemistry routes that are designed primarily for speed, flexibility and rapid analogue access. Such routes are rarely selected with large-scale manufacturability in mind and often rely on conditions that do not prioritise sustainable practices and may ultimately prove unsuitable for scale-up.
If these limitations only become apparent during clinical development, the resulting need for route or process redesign can be particularly costly, especially since changes at this stage may alter impurity profiles or the overall synthetic sequence. They increase development risk and may require extra comparability studies to show the modified process still delivers material of consistent quality, safety and performance. Introducing flow chemistry principles and flow-compatible route concepts during early-phase development can significantly reduce costs, lead times and regulatory burden when transitioning to highly intensified, cost-efficient and more sustainable processes. Rather than deferring process intensification until later clinical stages, an early flowbased strategy enables continued process adjustments throughout the entire development pipeline.
This creates a more consistent path from initial route selection to clinical and commercial manufacturing. Thus, increasing the probability that the selected chemistry can be seamlessly scaled without requiring major redesign or introducing regulatory risks.
16 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981