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?

SC3: Optimising Cell Culture Media

Instructors:

Ronan O’Kennedy, PhD, Consulting Bioprocess Specialist, ROK Bioconsulting

Anja Wüst, PhD, Project Manager, Media Development, Xell AG

To grow mammalian cells, researchers need to provide an optimal in vitro environment. The key feature of successful cell growth is the culture medium. “Achieving Super Soup” requires finesse and know-how in order to combine the right ingredients at the right times under the right conditions to achieve high titres. This workshop will provide a foundation for optimising cell culture media presented by real-world experts who will also tailor a portion of the course to fit concerns and challenges faced by the workshop participants.

Wednesday 20 March, 18:30 – 21:00

SC4: CMC Clinic: Where Am I Now and Where Do I Need to Be with My Dossier

Instructor:

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

Share your problems at the CMC regulatory clinic, learn how others have addressed them and gain new insights into what regulators are looking for. Puzzled by how to structure your dossier? Unsure if you have enough data for your next clinical trial application? Wondering how much data will be needed for approval? When does a problem need to be discussed with regulators and how should you approach them?

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

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.

SC6: Flocculation, Precipitation and Crystallization for DSP of Biopharmaceuticals - Detailed Agenda

Instructor:

Alois Jungbauer, PhD, Professor, Department of Biotechnology, University of Natural Resources Life Science, Vienna, Austria and Austrian Centre of Industrial Biotechnology

Flocculation, precipitation and crystallization are alternative methods to chromatography and membrane filtration for downstream processing of biopharmaceuticals. With the advent of integrated and/or continuous processing and feed stocks with much higher titers as in the past precipitation, flocculation, and crystallization again became very attractive. These techniques are and will be integrated into existing processes to intensify them. These methods are progressively integrated to new ones to establish simpler processes. In this workshop we will address the principles and methods for developing methods, scale up and large scale operation.