Recent Advances in Process Analytical Technology (PAT) for Downstream and Upstream Processing
Join our experts, and by attending this forum, you will:
- Gain an understanding of how process analytical technology (PAT) operates within both upstream and downstream process development.
- Learn about the link between modelling, chemometrics, and PAT in upstream and downstream processing.
- Obtain an overview of common analytes and analytical techniques used as PAT for cell culture/fermentation and purification.
Event overview
Process Analytical Technology (PAT) in biopharmaceutical manufacturing involves using real-time, in-line, and at-line analytical tools to monitor and control critical process and quality attributes across upstream (cell culture or fermentation) and downstream (purification of biological products) operations. This expert forum offers a comprehensive overview of PAT in upstream and downstream bioprocessing, emphasising its implementation, effects on yield, consistency, and scalability, and the roles of modelling and chemometrics in facilitating advanced monitoring and control strategies. Discover how the newest PAT tools are revolutionising bioprocesses by learning from experienced experts and examining real-world case studies.
It will also include a presentation on PAT and Real-Time Release Testing (RTRT), which have limited applications in aseptic manufacturing. In this presentation, we present a use case in which RTRT elements were incorporated into the release control system for a sterile Biotech drug product and implemented and filed at a commercial launch site. The main elements of this RTRT control strategy included:
- Implementing an RTRT sampling point
- Using Raman spectroscopy as a multi-attribute method
- Leveraging the existing rapid microbiology toolbox
Additionally, the presentation will cover regulatory feedback, lessons learned, the scale-out strategy, and the potential for other launches.
What you need to know:
Dual-time broadcast, with starting times as follows:
Wednesday, 9 December 2026
- Broadcast #1 (Europe / Asia): 09:00 h GMT (London) / 10:00 h CET (Paris/Berlin) / 14:30 h IST (New Delhi) / 17:00 h SGT (Singapore) / 18:00 h JST (Tokyo)
- Broadcast #2 (North America / Europe): 08:00 h PDT (Los Angeles) / 11:00 h EDT (New York) / 16:00 h BST (London) / 17:00 h CEST (Paris/Berlin)
Duration: Approximately 60 – 90 minutes, incl. Q&A.
Who should attend?
Anyone interested in real-time monitoring to improve yield, consistency, and scalability, or in integrating in-line and at-line analytical tools with control systems, whether for practical use or regulatory compliance, within biopharmaceutical analysis.
- Upstream Process Development (USP) Scientists / Engineers
- Downstream Process Development (DSP) Scientists / Engineers
- Bioprocess Engineers
- Manufacturing Science and Technology (MSAT) Specialists
- Biologics Quality Control (QC) or Quality Assurance (QA) Scientists
- Process Automation / Control Systems Engineers
Prof. Dr. Marieke KlijnDelft University of Technology (The Netherlands)After an MSc in Biochemical Engineering and a PhD in protein analytics and machine learning, Marieke established a research group at Delft University of Technology in 2020, focusing on applying advanced analytics to understand, develop, and control bioprocesses. The group’s research spans microbial fermentation to ATMP production, with synergies in the application of in-line analytics, the development of technology to accelerate data-driven modelling, and work towards data-driven control strategies.
Dr. Lorenz LiesumHead of Advanced Analytical ScienceRoche (Switzerland)With a background in Chemistry and Mathematics, Lorenz holds a Ph.D. in Physical Chemistry from ETH Zurich. He began his career in the pharmaceutical industry at Novartis as an analytical scientist in pharmaceutical development. For more than 15 years, he has specialised in Process Analytical Technology (PAT), including involvement in regulatory Quality by Design (QbD) filings. Lorenz currently serves as the Head of Analytical Science for Roche Global QC. In this role, he leads the Instant Release capability team, driving the implementation of new technologies and control strategies throughout the internal manufacturing network. Further presenters/panellists to be confirmed.
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Prof. Dr. Cari Sänger-van de GriendScientific DirectorBioQCExpert in (bio)pharmaceutical analytical chemistry with 30 years of industrial and academic experience in method development and control strategies, including Analytical Quality by Design (AQbD), and focused on best practices and knowledge sharing.
Dr. Ewoud van TrichtScientific DirectorBioQCExpert in (bio)pharmaceutical analysis with over 18 years of industrial experience in analytical development, Quality Control, and Analytical Quality by Design (AQbD). He has contributed to diverse therapeutic modalities, including small molecules, viruses, and cells, at leading companies such as Janssen Vaccines and Sanofi Cell Therapy.
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