互动分组讨论

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2024年3月19日(二) 17:50 - 18:30

CELL CULTURE AND BIOPRODUCTION

BREAKOUT DISCUSSION 1:
Digital Bioprocessing and Industry 4.0: How Far Along Are We?
Mark Duerkop, CEO, Novasign GmbH

  • Critical evaluation of the current industrial evolution
  • AI vs mechanistic modelling: what to choose?
  • Workflow vs data: where to invest?
  • Outlook how AI will change the way of bioprocessing in the future

ADVANCES IN RECOVERY AND PURIFICATION - PART 1

BREAKOUT DISCUSSION 2:
ICH Q5 A (R1) Revision: Viral safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
Alois Jungbauer, PhD, Professor & Head, Biotechnology, Institute of Bioprocess Science and Engineering, University of Natural Resources and Life Sciences (BOKU)

  • Expectations
  • What has changed
  • Impact on bioprocessing

GENE THERAPY CMC AND ANALYTICS

BREAKOUT DISCUSSION 3:
Analyze This: AAV-based Gene Therapies
Rajiv Gangurde, PhD, Vice President, Technical Operations, Parexel

  • Gene therapy analysis
  • Ensuring product quality
  • In-house and outsourced resources
  • Regulatory implications

ANALYTICS AND CHARACTERISATION

BREAKOUT DISCUSSION 4:
Challenges and Opportunities Towards Analytical Development for Next Generation Manufacturing (NGM) Process Optimization
Rahul Mishra, PhD, Senior Analytical Scientist, AstraZeneca

  • How we can proceed with the High throughput analytical methods (size, charge, fragments, and glycan) to support the NGM process?
  • Is there opportunity for characterization methods to be scaled up for High throughput analysis?
  • What are the risk and challenges?

PROCESS OPTIMISATION FOR CULTIVATED MEAT

BREAKOUT DISCUSSION 5:
Technological Hurdles Cultivated Meat Still Needs to Master
Aleksandra Fuchs, PhD, Senior Scientist, Austrian Centre of Industrial Biotechnology

  • Cell culture medium - is there still a potential for lowering the price?
  • Do we expect a breakthrough in bioreactor design?
  • What is the potential of computational approach/AI in mastering these hurdles?

2024年3月20日(三) 18.00 - 18.30

CELL LINE DEVELOPMENT

BREAKOUT DISCUSSION 1:
The Role and Future of Cell Line Engineering for Product Quality Optimization
Emanuel Kreidl, PhD, Senior Expert, Science & Technology, Technical Research & Development, Novartis Pharmaceutical Manufacturing GmbH

  • Current trends
  • When to implement in the development process? Is it possible to address and/or initiate this as part of the QbD process?
  • Removal of protein from expression cell line vs. introduction of GOI into dedicated knockdown/knockout cell line?
  • IP, especially in the context of long development timelines - potential advantage of late filing?

INTENSIFIED AND CONTINUOUS PROCESSING

BREAKOUT DISCUSSION 2:
Digitalization of Biomanufacturing
Michael Sokolov, PhD, Lecturer, ETH Zurich

  • Implementing Digital transformation
  • Role of AI/ ML in Bioprocessing
  • Shared experiences

GENE THERAPY MANUFACTURING

BREAKOUT DISCUSSION 3:
Future Directions in Gene Therapy Manufacturing
Eduard Ayuso, DVM, PhD, CEO, DINAMIQS; Chairman of Manufacturing, European Society of Gene and Cell Therapy

  • Industrializing Gene Therapies - what have we learned from commercial products
  • Cell line development to process development
  • Technology gaps in process development - upstream to downstream

BREAKOUT DISCUSSION 4:
Viral Vector Process Development and Formulation
Tarik Senussi, PhD, Senior Director Process & Formulation Development, MSAT, Gyroscope Therapeutics, a Novartis Company

  • Moving from Upstream to Downstream Processing
  • Formulation Strategies
  • Fill Finish

FORMULATION AND STABILITY

BREAKOUT DISCUSSION 5:
Technical Transfer of Drug Product Manufacturing Process for Early Stage Programs (Phase I)
Japneet Kaur, PhD, Senior Scientist, CMC, Takeda Pharmaceuticals

  • Limited process information
  • Limited drug substance availability for scale up
  • Tight timelines for tech transfer and CTM batch manufacturing
  • Internal vs external manufacturing
  • CMO/CDMO selection process

PROCESS OPTIMISATION FOR PRECISION FERMENTATION

BREAKOUT DISCUSSION 6:
Essential Ingredients for Economic Precision Fermentation Solutions
Christoph Herwig, PhD, former Professor, Bioprocess Engineering, TU Wien; CPO, Fermify GmbH; Founder, Lisalis

  • What is precision fermentation compared to recombinant protein production of biopharmaceuticals?
  • How to achieve the drastically different unit economics?
  • What is the role of digital transformation and digital twins?
  • What can the biopharma sector learn from precision fermentation?

* 活动内容有可能不事先告知作更动及调整。

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