Learn how data science can be beneficial for successful tech transfer from development to commercial and from site to site. The speakers will share tips on designing robustness to identify NORs and PARs for platform based, scale and site independent control strategies; focusing on critical unknowns for data science assisted risk assessment and data science for proving comparability; how to anticipate holistic criticality by using digital twins/integrated data analytics for anticipating critical process parameters along the full process chain and strategies for compensating the differences in process control strategies.
- Learn how data science can be beneficial for successful tech transfer
- Get familiar with data science tool, such as comparability analysis, power analysis and integrated process modelling
- Realize, that the tools can be applied along the product life cycle as emphasized in ICH Q12
Meet the Speakers:
Christoph Herwig, bioprocess engineer from RWTH Aachen, worked in industry in the design and commissioning of large chemical facilities prior to enter his interdisciplinary PhD studies at EPFL, Switzerland in bioprocess identification. Subsequently he positioned himself at the interface between bioprocess development and facility design in biopharmaceutical industry. Since 2008, he is full professor for biochemical engineering at the Vienna University of Technology. The research area focuses on the development of data science methods for integrated and efficient bioprocess development along PAT and QbD principles for biopharmaceuticals. In 2013 he founded the company Exputec addressing data science solutions for the biopharma life cycle.
Thomas Zahel is head of innovation at Exputec, with outstanding experience in statistics, algorithm development and turning complex challenges into easy concepts for our clients. His background is in bioprocess engineering and he holds a PhD in applied statistics for process development and validation. He is most passionate about developing new statistical methods that turn data into knowledge. He has successfully helped top-ranked biopharmaceutical companies to develop, improve and validate their processes according to regulatory compliance.