Leveraging Integrated Continuous Manufacturing to Address Critical Issues in the U.S. Military.

There is a tremendous opportunity to modernize the pharmaceutical manufacturing industry-relinquishing outdated machines that have been used for decades, and replacing them with state-of-the-art equipment that reflect more contemporary advanced technologies. This article describes how the implementation of continuous manufacturing, replacing outdated batch systems, can positively impact our health care sector. Important benefits will include the creation of advanced pharmaceutical manufacturing jobs in the United States, the establishment of capabilities and capacity to quickly produce drugs critical to U.S. citizens, the reduction of health care costs through more efficient manufacturing, and access to better quality drugs through more sophisticated and reliable production processes. Furthermore, the application of continuous manufacturing will enable the U.S. Government, in partnership with pharmaceutical companies, to address current issues such as drug shortages, national emergencies (eg, natural disasters or chemical, biological, radiological, or nuclear threats), the Strategic National Stockpile (ie, improving response time and reducing maintenance costs), and the delivery of critical drugs to distant geographies (eg, forward military bases). The article also provides a detailed example of a critical aspect of continuous manufacturing: the ability to overcome technical challenges encountered by batch technologies.