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 EDT / 7:00am PDT / 2:00pm GMT / 3:00pm CET / 10:00pm CST / 7:30pm IST | Olav Lyngberg, Advanced Analytics, Modeling & Process Analytical Technology Leader at The Janssen Pharmaceutical Companies of Johnson & Johnson and Mark Isaacs, VP of Sales at IDBS |BOOK FREE SEAT FOR THIS WEBINAR

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 of 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 manufacturers 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. In the last 9 years with Janssen, he has been leading a team delivering mechanistic modelling, 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 months of a large-scale manufacturing facility, significant improvements in operational excellence for several vaccines 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.

Mark Isaacs, VP of Sales at IDBS

Mark has 30 years of experience in senior-level, global business development focused on bringing innovative solutions to the life science industry. His expertise combines a technical understanding of manufacturing challenges with the commercial application of software solutions to maximize value realized from improved product quality and increased process understanding. Mark holds a BS in Natural Sciences/Chemical Engineering and a Master’s Degree in Chemical Engineering from the University of Cambridge. He is also a member of the International Society for Pharmaceutical Engineering and has served on several industry advisory boards.

Sponsored by IDBS

IDBS helps BioPharmaceutical organizations accelerate the discovery, development and manufacturing of life-changing therapies that advance human health worldwide. From lab through manufacturing, IDBS leverages its 30+ years of experience working with a diverse list of customers – including 18 of the top 20 global BioPharma companies – and deep expertise in scientific informatics and process data management to tackle today’s most complex challenges. Known for its signature IDBS E-WorkBook product, IDBS has extended solutions across the entire value chain for BioPharma Lifecycle Management (BPLM). Built on analytics-centric and cloud-native technology, IDBS Polar and Skyland PIMS platforms are powered by a digital data backbone to drive faster and smarter decisions in drug development and across the supply chain. 

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