The increasing complexity of new chemical entities (NCEs) is leading to a rise in hazardous chemistries that form key steps in the synthetic manufacturing processes. As a result, API manufacturers are faced with an increased manufacturing risk relating to product quality, worker safety and environmental impact. In many cases, it is proving beneficial for pharmaceutical companies to reduce their risk by employing contract manufacturing organisations (CMOs) to perform the hazardous steps. As such CMOs are increasingly faced with the need to offer a wide variety of chemistries and manufacturing capabilities at varying scales.
In this article, Paul Moscrop, Process Engineering Manager at Sterling Pharma Solutions, outlines the current trend for hazardous chemistry in the API manufacturing space and discusses the necessity of process hazard evaluation. He also explores the importance of integrating process engineering and chemistry expertise within an organisation to ensure project success, whilst still maintaining a safe plant, ensuring workforce safety and protecting customer confidence.
Trends in hazardous chemistry
Hazardous chemistry is often essential to access a particular functionality within a specific molecule. Although not always necessary, the technique can also result in additional benefits such as cleaner chemistry with fewer or no side reactions, or provide a more direct route to a molecule with fewer processing stages. These advantages reduce cost by consuming less material, providing easier purification, producing less waste and reducing capital equipment and processing time.
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