Short Courses*

Monday 18 March, 13:00 – 16:00

SC1: Continuous Processing Masterclass - Detailed Agenda

Instructor:

Margit Holzer, PhD, Owner, Ulysse Consult

The manufacture of biopharmaceuticals using semi- or fully continuous processes has the potential to improve product quality and increase the productivity of biomanufacturing facilities. This short course details the principles and practical challenges of implementing a continuous process strategy. Using examples and shared experiences, the course covers continuous processing definitions and drivers, technologies and processes, process development and control, and quality considerations.

SC2: Potency Assays for Cell and Gene Therapies - Detailed Agenda

Instructor:

Christopher Bravery, PhD, Consulting Regulatory Scientist, Consulting on Advanced Biologicals, Ltd.

Potency assays are an essential concept in determining the quality of any biological medicinal product/biologic. Extending this concept to cell and gene products is more challenging and often the most difficult aspect of characterising these products. The relevance of the approach taken is often challenged by regulators both during development and when seeking market approval. This workshop will lead you through the issues and how to develop an overall potency strategy.

• What is potency and why is it so important?
• How do I develop potency assays?
• What are the regulatory expectations for potency assays?

Wednesday 20 March, 18:30 – 21:00

SC5: Saving Time in Process Development with Next-Generation Methods: iDoE, Hybrid Modeling and PAT - Detailed Agenda

Instructors:

Moritz von Stosch, PhD, Senior Manager, Drug Substance, Technical R&D, GSK Vaccines

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

Mark Dürkop, PhD, Project Leader, Biotechnology, University of Natural Resources and Life Sciences (BOKU)

In this short course, we show how a more accurate design space can be defined that provides increased flexibility for process operation based on the iDoE-hybrid modeling strategy. We also show how advanced monitoring strategies support the tracking of the deviations and how these methods can readily be developed from the iDoE data. It will be illustrated how the combination of the hybrid model with monitoring can directly be exploited for process control, thus naturally evolving the last step of the QbD roadmap.