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 beneficial 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 program intends 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 at Janssen Supply Chain. In the last nine 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 has, among many things, been the approval of two real-time release products, a reduction in the qualification timeline by 4.5 months at 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.

Followed by a presentation on:

How digital strategies and data standards can overcome process monitoring challenges and ensure quality across external networks

Streamlining the flow of accurate and timely data across internal and external teams, sites, and partners is critical for successful tech transfer and ensuring your process variability is understood and minimized. This requires more standardized and digitized approaches to collaboration. You’ll leave this session with a solid foundation on

• How cloud-based process information management systems (PIMS) improve data visibility, collaboration, and process performance
• The role of digital data sharing in accelerating tech transfer and business and regulatory reporting, including cGMP CPV
• How industry collaborations such as BioPhorum are helping to ensure reliable information sharing to support supply visibility and ensure quality
• Best practices to successfully engage and onboard partners for seamless data capture, verification, and analysis

Presented by Teodor Leahu, Director of European Operations at IDBS

Teodor has 14 years of expertise as a scientist in biotech process development, design, optimization, and validation. His successful track record building and managing technology roadmaps for GMP manufacturing, including software selection, qualification, and implementation, positions him as a respected advisor on maximizing operational efficiency to accelerate scale-up, tech transfer, and commercial release. Before joining IDBS, Teo served as a Process Development Scientist at Emergent BioSolutions, where he led science and technology for a newly developed orphan disease vaccine. Previously at Merck Healthcare, his roles spanned Bioprocess Development Scientist and Compliance Specialist for Downstream Processing. Teo holds a BS in Biomedical Engineering from Yale University and an MS in Biotechnology and Bioengineering from EPFL (Swiss Federal Institute of Bioengineering).

Sponsored by IDBS

IDBS provides purpose-built software solutions to address the data management challenges prominent across the BioPharma lifecycle and supply chain. 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 help our customers accelerate life-changing therapies time to market. Known for its signature IDBS E-WorkBook product, IDBS has extended our solutions portfolio 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 development and manufacturing.