How to enhance the safety of your drug substance synthesis process by smart chemical design?

How to enhance the safety of your drug substance synthesis process by smart chemical design?

Scaling up the synthesis process of new chemical entities may require the use of hazardous reaction conditions or reagents. It is essential to develop a thorough understanding of the chemistry involved to prevent unsafe situations.

At Ardena, we design synthesis processes that are intrinsically safe. During the proposal preparation process, we identify hazardous chemical transformations and reagents. We inform our customer on potential safety issues and propose alternative reaction conditions and/or reagents during the project chartering phase. During process development, all chemical reactions are thoroughly assessed for hazards.

Many accidents in chemical plants are caused by poorly controlled heat-releasing (exothermic) reactions. It is therefore critical to know the energy content of each reaction and to develop chemical processes in such a way that exothermic reactions are controllable or dose-controlled and thus stoppable at any point during processing.

Our internal governance at Ardena ensures that such exothermic events are properly assessed via tools such as reaction calorimetry and differential scanning calorimetry. Reaction calorimetry is a well-established technique to determine the thermal profile of a reaction and its associated temperature change, whereas differential scanning calorimetry analysis is used to identify the onset temperature of hazardous events.

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