3월 18일(월), 13:00 – 16:00
SC1: Continuous Processing Masterclass
( SC1: 연속 프로세스 마스터클래스 )
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
( SC2: 세포치료제 및 유전자 치료제의 역가시험 )
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?
3월 20일(수), 18:30 – 21:00
SC5: Saving Time in Process Development with Next-Generation Methods: iDoE, Hybrid Modeling and PAT
( SC5: 차세대 이론에 의한 프로세스 개발 시간 단축 : 하이브리드 모델의 DOE 및 PAT )
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.
* 주최측 사정에 따라 사전 예고없이 프로그램이 변경될 수 있습니다.