インタラクティブ・ブレイクアウトディスカッション・グループ

研究者や業界専門家との徹底的な討論に参加し、自身の研究の成果や傾向、直面した課題について深く議論することができます。

インタラクティブ・ブレイクアウトディスカッション・グループは、将来の協力者とのネットワーク作りに不可欠な役割を果たします。また、研究成果をシェアしたり、仲間とアイデアを出し合い、グループでの問題解決の取り組みに参加する機会を提供します。

2024年3月19日（火） 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（水） 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?

* 不測の事態により、事前の予告なしにプログラムが変更される場合があります。