SC5: Saving Time in Process Development with Next-Generation Methods: iDoE, Hybrid Modeling and PAT
Wednesday, 20 March 2019 | 18:30 – 21:00 | Dinner Short Course

18:30 Introduction to QbD and Advanced Process Monitoring Approaches/PAT Analyzers

Gerald Striedner, PhD, Associate Professor, Biotechnology, University of Natural Resources and Life Sciences, Vienna (BOKU)

Focus will be laid on critical issues in context with advanced process monitoring and product characterization strategies. Data driven soft sensor applications will be discussed as a possible solution.

Agenda:

• Critical aspects of on- and offline monitoring strategies for process- and product characterization
• Soft sensors and statistical modeling

19:10 Dinner

19:40 Hybrid Modeling and iDoE for QbD and PAT

Moritz von Stosch, PhD, Senior Manager, Process Systems Biology and Engineering Center of Excellence, Technical Research and Development, GSK Vaccines

Hybrid modeling and intensified Design of Experiment approaches for process optimization and characterization will be discussed and their application for an industrial E.coli based processes will serve as example.

Agenda:

• Hybrid modeling: Approach, key benefits and applications
• Intensified DoE for fast and efficient process characterization & process optimization

20:20 Introduction of the Hybrid Modeling Toolbox

Mark Duerkop, PhD, Project Lead, Biotechnology, University of Natural Resources and Life Sciences, Vienna (BOKU)

Based on the previous discussed advantages of hybrid models a hybrid modeling toolbox will be presented. The handling of the toolbox and the benefits will be demonstrated on both a DoE and intensified Design of Experiments (iDoE) E. coli fed-batch data set.

Agenda:

• Introduction of the toolbox (display, data preprocessing, workflow)
• Demonstration of the ability to reduce process development and characterization times by applying the toolbox on iDoE data.

21:00 End of Course

Instructor Biographies

Gerald Striedner, PhD, Associate Professor, Biotechnology, University of Natural Resources and Life Sciences, Vienna (BOKU)

Gerald is an Associate Professor at the Department of Biotechnology (BOKU), head of the working group microbial fermentation, and principal investigator in the Austrian Center of Industrial Biotechnology (ACIB). The working group has established an integrated systems approach for bioprocess development and is focused on the implementation of PAT and QbD concepts in bioprocessing and rational host cell design. CHO, E. coli, insect cells and vero cell lines are used as expression systems for production of a representative set of biopharmaceuticals (mABs, Fabs, scFvs, VLPs, viruses, DNA).

Moritz von Stosch, PhD, Senior Manager, Technical Research and Development, GSK Vaccines

Moritz von Stosch leads the Process Systems Biology and Engineering Center of Excellence at Technical R&D, GSK Vaccines, Belgium. He is a process systems engineer by education with a degree in Chemical Engineering from the RWTH-Aachen University (Germany), and PhD in Biochemical Engineering from the University of Porto (Portugal). Before joining GSK, Moritz worked as a Lecturer at the School of Chemical Engineering and Advanced Materials at Newcastle University, where his research focused on the development of intensified Design of Experiment approaches and novel hybrid modeling methods as well as their application to enable more efficient process operation/design. He has contributed to more than 25 publications in international peer-reviewed journals.

Mark Duerkop, PhD, Project Lead, University of Natural Resources and Life Sciences, Vienna (BOKU)

With more than nine years of experience, Mark is a passionated scientist in the field of biopharmaceutical process development. He worked together with Novartis and Boehringer-Ingelheim targeting their needs in process development and understanding. Together with his team, he is developing a QbD software for both up and downstream processes. This software utilizes process data and first principle models (hybrid models) to quickly predict critical quality attributes (CQAs) from critical process parameters (CPPs). Hereby, bioprocess development and characterization will be accelerated significantly while simultaneously a better process understanding is gathered. From this research project the company “Novasign” will be founded within 2019 offering this unique software solution.