Modern approach to advanced pharmaceutical manufacturing | Statement from US FDA Commissioner

One of today’s most important tools for modernizing the pharmaceutical industry is a process known as continuous manufacturing (CM). This approach transforms the traditional, step-wise manufacturing processes into a single system that’s based on modern process monitoring and controls. It enables a steady output of finished drug products as raw materials are continuously added to the closed system.

Today, we’re taking new steps to help advance the adoption of these manufacturing innovations.

The closed and continuous nature of these CM systems means that the process is easier to control than the decades-old, traditional “batch” manufacturing. Under that traditional approach, the finished drug product is made using a long series of discrete steps that involve many stops and starts. Each step in this traditional staggered manufacturing process introduces a degree of complexity and uncertainty.

CM helps to ensure consistently-made products, allows manufacturers to more easily scale their manufacturing operations to meet demand, and can help reduce drug shortages by minimizing operational stops and starts. CM systems also require smaller footprints to operate. The high tech and small footprint attributes of these systems promote localized manufacturing, helping to shorten the drug supply chain. Furthermore, these continuous processes are much more efficient. This may help manufacturers reduce costs of production in the long run. This efficiency could eventually be captured for consumers in the form of lower drug prices.



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