Rapti Madurawe
US FDA Director, Office of Process and Facilities, Center for Drug Evaluation and Research
FDA generally gets favorable feedback on continuous processing. That said, implementing continuous manufacturing does require a capital investment up front. There is also a learning curve involved the first time a company implements a continuous manufacturing process. Constraints like these may pose a challenge for some companies, particularly when considering their existing investment in batch manufacturing. It is up to each company to decide whether continuous manufacturing is a practical approach for a specific product in their portfolio.
The monetary advantages of continuous manufacturing are more likely to be realized over a longer timeframe. Continuous manufacturing facilities and equipment are significantly smaller compared to batch manufacturing. These can reduce operational costs such as utility usage, waste, solvent use, and staffing, among other considerations. Continuous manufacturing also naturally lends itself to rapid process development, and a batch size increase is usually achieved by increasing run time without requiring a change to equipment size. This can help reduce the time from development to market. Since continuous manufacturing also allows for more nimble testing and control, it can help reduce the likelihood of manufacturing failures.