Creation of a real time process data framework with external manufacturer... - Seguridad Mania.com - España y América Latina

Full Title: Creation of a real time process data framework with external manufacturer to enhance process performance, technology transfer success and drive cost savings Janssen Supply Chain is embarking on a journey towards Industry 4.0 through the implementation of a network wide program to connect real-time process data from Janssen’s external suppliers with Janssen’s digital twins. This program is a mutually beneficially collaboration in which data sharing enables manufacturing performance monitoring and optimization against the full network wide process history and performance. Each supplier in real-time can track their process performance on a detailed and actionable level. The tracking can be in the form of proactive process performance reviews, avoidance of failure by correcting issues as they occur, alarming on complex univariate or multi-variate signals or comparing with predicted optimal process trajectories, as examples. During tech transfer this approach can provide other benefits such as, trending the current tech-transfer against lab and clinical scale data and the ability to see the expected outcome against quality and performance attributes. The intent with the program is to connect to Janssen’s strategic suppliers by 2024 and long-term connect all core and strategic suppliers. At the time of writing a half dozen suppliers have live connections and another handful are connected via hourly or daily data links. Internal and external use of process data monitoring with associated multi-variate models and alarming have resulted in >10 batches being saved and valuable yield improvements in the biologics-based processes analyzed. Janssen looks at external and internal data sharing as a win-win application of digital technology that enables external manufactures to perform optimally, while sponsor companies benefit from enhanced reliability, lower cost, and better assurance of quality.