We are living in exciting times with a veritable explosion in our understanding of human biology, providing insight into how we can prevent and treat disease. Approaches for preventing, controlling and curing many serious conditions like cancer and heart disease are advancing rapidly, and these are increasingly in the form of biologics. The fundamental question is obvious, “Are we ready to meet the demands of this future state and deliver the opportunities that biologic therapies offer?” While advances in technology in the biopharma industry over the past decade are very promising, the rate of change over the last 40 years or so has been relatively slow. The complexity of reproducibly manufacturing biologics in a highly-regulated environment has propagated conservative approaches by both the industry and regulatory agencies. The slow rate of improvements in manufacturing technologies runs the risk of impeding the acceptance and affordability of promising biologic therapies. This talk will survey some of the patterns and trends in the biopharma industry, as well as offer some possible solutions. One such solution is the title and focus of this conference; Integrated Continuous Biomanufacturing
