Creation of a real time process data framework with external manufacturer to enhance process performance, technology transfer success and drive cost savings
08th February 2023 | 10:00am EST / 7:00am PST / 3:00pm GMT / 4:00pm CET | Olav Lyngberg, Advanced Analytics, Modeling & Process Analytical Technology Leader at The Janssen Pharmaceutical Companies of Johnson & Johnson |WATCH FOR FREE
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.
Presented by Olav Lyngberg, Advanced Analytics, Modeling & Process Analytical Technology Leader at The Janssen Pharmaceutical Companies of Johnson & Johnson
Olav is a Sr. Scientific Fellow and group leader within Technical Operations, Janssen Supply Chain. The last 9 years with Janssen he has been leading a team delivering mechanistic modeling, process analytical technology and advanced analytics solutions for large and small molecule active pharmaceutical ingredients and drug product processes. The outcome of these efforts, have among many things, been the approval of two real time release products, the reduction in qualification timeline by 4.5 month of a large-scale manufacturing facility, significant improvements in operational excellence for several vaccine and monoclonal antibody products, as well as countless technology transfers impacted positively with reduced timelines and expenses. Olav holds a Ph.D. in Chemical Engineering from the University of Minnesota where he studied under Professors Scriven and Flickinger. He holds a Master of Science degree in Chemical Engineering from The Technical University of Denmark where he studied with Prof. Jens Nielsen. Olav started his industrial career in Chemical Development with Bristol-Myers Squibb in 2000.