Recent Industrial Roadmaps to Enable Smart Manufacturing of Biopharmaceuticals

Biopharmaceutical manufacturing is an evolving industry with great potential to improve public health, but laden with technical and operational challenges. It has many features that are similar to other smart manufacturing industries, but it also has some unique features that are specific to the biological domain in which it operates. Both types of features have been carefully explored in recent industrial roadmaps to guide the research, development, and manufacturing of biopharmaceuticals. These roadmaps explicitly identify “fully automated facilities” and “knowledge management” as two of the critical enabling capabilities that will drive the biopharmaceutical industry in the next decade. This article describes these roadmaps to identify the emerging opportunities and future directions in this knowledge-intensive manufacturing industry. It also serves as a “call for action” for collaboration among key stakeholders, including the robotics and automation community.