Flow Chemistry for Drug Substance Manufacturing

Continuous Flow Chemistry – An Enabling Technology within the Pharmaceutical Industry

The adoption of continuous flow chemistry as an enabling tool by the pharmaceutical industry, especially CDMO and CRO-based businesses for drug substance manufacturing, was initially slow but in recent years has accelerated. While implementation of these techniques requires notable investment – both in terms of staff training and infrastructure – the opportunities and benefits are clear. Reactions are more scalable, reliable, and controllable. Of key importance are the safety improvements, particularly in relation to reducing the risk of thermal runaway, use of gases or high energy materials as reactants or reagents and controlling worker exposure to toxic materials.

This short white paper gives a brief overview of flow chemistry within a drug substance setting, particularly outlining the safety advantages, and presents an example where Pharmaron has successfully implemented a continuous flow chemistry approach.

Key takeaways

• Flow chemistry is an enabling technology with considerable safety gains.
• Use of continuous flow chemistry for large-scale processing of pharmaceutical materials is gaining traction
• There are significant advantages within economics, safety, and environmental impact
• Case study: the Pharmaron team used a continuous flow approach for a 40 kg reduction of a nitro group during production of an API, a transformation fraught with risk.