Interactive Breakout Discussions
Interactive Breakout Discussions are informal, moderated discussions, allowing participants to exchange ideas and experiences and develop future collaborations around a focused topic. Each discussion will be led by a facilitator who keeps the discussion on track and the group engaged. To get the most out of this format, please come prepared to share examples from your work, be a part of a collective, problem-solving session, and participate in active idea sharing.
These will take place IN-PERSON ONLY.
TUESDAY, 19 MARCH 2024, 17:50 – 18:30
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
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
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
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?
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?
WEDNESDAY, 20 MARCH, 2024, 18.00 – 18.30
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?
BREAKOUT DISCUSSION 2:
Digitalization of Biomanufacturing
Michael Sokolov, PhD, Lecturer, ETH Zurich
- Implementing Digital transformation
- Role of AI/ ML in Bioprocessing
- Shared experiences
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
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
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?