Simulation Modeling of Drug Substance Tech Transfer Timelines at Amgen

Abstract

Technology transfer (TT), or the process by which a product's manufacturing is moved and scaled, is a complex business process with countless deliverables and stakeholders. This is especially true in biomanufacturing, where drug commercialization timelines are measured in years, manufacturing facilities are specially designed, and regulations must be stringently met. This systems-level complexity can create inefficiencies in the TT process, lengthening timelines and wasting resources. In this project, we use simulation modeling techniques to digitally model Amgen's Commercial Tech Transfer (CTT) process for biologic drugs. We use virtual experimentation to identify key bottlenecks in the TT workflow, quantify how workstream alterations impact project timelines, and identify process changes likely to shorten timelines. We also extend this analysis to Amgen's New Product Introduction (NPI) process, identifying how coordination between upstream and downstream processes may accelerate NPI timelines. Finally, we link this project to the ongoing development of TT data visualization dashboards.