Perspectives on integrated continuous bioprocessing - opportunities and challenges

Biopharmaceuticals are currently produced almost entirely using batch operations. Integrated continuous processes have the potential to revolutionize bioprocessing, leading to significant reductions in manufacturing costs and facility size while improving product quality through enhanced uniformity in the microenvironment. This paper examines the potential opportunities and challenges in implementing continuous processes for the production of high value biological products. Although regulatory agencies seem highly open to continuous processing, there are significant technical and practical issues that must be addressed to move the industry in this direction, including the development of effective alternatives to traditional downstream processing operations. Continuous processing could provide unique opportunities for the production and delivery of low-cost biopharmaceuticals for solution of major global health challenges in the coming decades.