Recently the FDA issued a new draft guideline for continuous manufacturing of small molecule drugs. With these draft guidelines the FDA wants to engage more pharmaceutical manufacturers to shift from traditional batch/start-stop processing to continuous manufacturing. The main advantages associated with these processes are more room for modularity, automation and flexibility due to a smaller footprint, but also more consistent quality of the drug product. Of course the main incentive for the FDA to promote this way of processing is that it believes that this will have a positive impact on drug prices and prevent drug shortages.
Throughout the evolution of manufacturing, many industries have gradually shifted away from batch process to continuous process manufacturing as production technologies matured. This has included industries such as chemical, petroleum, steel, automobile, consumer goods and food manufacturing.