Application of lean and continuous improvement methodologies at a biopharmaceutical manufacturing site

Abstract

Heightened competitive pressures, changes in the regulatory atmosphere, and dropping research and development productivity have been plaguing the pharmaceutical and biotechnology industries. Amgen has felt the effects of these forces and launched a new effort to improve its operations via continuous improvement and Lean, ultimately reducing costs and improving productivity of operations. This thesis examines one example of a process improvement effort at Amgen's Fremont manufacturing facility. This project involved characterizing the cycle times of their buffer solution preparation processes, leading to targeted actions to both minimize variability in the process and to reduce the amount of time and effort to manufacture tanks of buffer solution. Tools and ideas from Lean and Six Sigma were applied and a prioritized action plan was presented to the company. This thesis also provides a broader examination of how such continuous improvement efforts can fit into the biotechnology industry with its idiosyncrasies.