Modeling the effects of advanced automation and process design on Cell Line Development

Abstract

Research and development of biologic drugs is a time- and resource-intensive process that can span several years and billions of dollars. Any improvements in the efficiency and end-to-end cycle time of this process provide value to producers in the form of reducing at-risk investment in new drug programs and improving speed to market. Cell Line Development (CLD), a major portion of the research and development lifecycle, is responsible for creating the parent cell for these new drug programs. The biotechnology industry has made great gains in CLD technologies and procedures, though many fields continue to advance and can further contribute to improved operational efficiency. This thesis proposes a methodology for evaluating CLD systems, characterizing alternative processes and technologies, and determining the ideal investments that can maximize system efficiency and processing speed. Approaches that are currently available in the industry are reviewed and used as model inputs to determine realistic short-term gains. Furthermore, nascent technologies that may reach industrial applicability are considered for an additional potential system design. Pfizer's CLD system is used as a case study, in which it is shown that total system utilization and cycle time can be improved by 29.6% and 8.8%, respectively, through the use of currently available technologies and procedures. The costs and risks of the new approaches are reviewed and found to be significantly low when compared with these gains. As technologies continue to develop in the future, they may further improve CLD system performance. However, the majority of gains are achieved by applying currently available approaches.