This presentation summarizes the rapid deployment of a real-time multivariate process monitoring system and at Takeda leveraging the data from OSIsoft PI. It will cover the entire process starting from system conceptualization to implementation of SIMCA Online, which took less the 9 months. The talk identifies the OSIsoft PI system configurations within Takeda that enabled the quick implementation as well as the challenges overcome including shifting the company culture. Finally, it examines the use of the SIMCA Online system for ensuring process consistency during a tech transfer of a process from a CMO to an internal manufacturing facility.
Jeff Simeone is an Associate Director at Takeda, Inc. working with the Manufacturing Sciences group. He joined Takeda (Shire) in January 2016 providing technical support for cell culture operations. Jeff has worked in the biotechnology industry for 18 years. He has spent a majority of that time working in Process Analytics and has been instrumental in the development and deployment of SIMCA Online systems at several facilities.