Recent Industrial Roadmaps to Enable Smart Manufacturing of Biopharmaceuticals

Abstract

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. Note to Practitioners —The market for biopharmaceuticals has been rising rapidly in recent years. It is now a multibillion dollar industry with its own ecosystem of suppliers, medical professionals, drug delivery systems, and regulators. The healthcare benefits promised by biopharmaceuticals are impressive, but there are several research, development, and manufacturing challenges that must be overcome to deliver on these promises. The biopharmaceutical industry, in collaboration with academics and government laboratories, has published a series of roadmaps recently to address these challenges. “Fully automated facilities” and “knowledge management” have been explicitly identified in the roadmaps as two of the critical enablers to meet these challenges. This article summarizes the findings of these industrial roadmaps and provides a clear picture of the collaborative efforts needed to succeed in, and grow, this promising industry.