인터랙티브 브레이크아웃 디스커션

인터랙티브 브레이크아웃 디스커션은 비공식 및 모더레이트 유형의 디스커션입니다. 참가자는 아이디어 및 경험을 교환하고, 특정 토픽에 대해 향후 협업을 발전시킬 수 있습니다. 각 디스커션은 진행자가 주도하며, 진행자는 토론의 진행과 그룹 참여도를 유지합니다. 이 기회를 최대한 활용하려면 자신의 연구 사례를 공유하고, 집단적인 문제 해결 세션에 참가하며 활발한 아이디어를 공유할 준비를 해주시기 바랍니다.

인터랙티브 브레이크아웃 디스커션은 대면 형식으로만 진행됩니다.

3월 19일(수) 18:00 - 18:30

Cell Culture and Cell Line Engineering - Part 2

TABLE 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 on how AI will change the way of bioprocessing in the future

TABLE 2: Economic and Sustainability Considerations for Hybrid Processes (Single Use/Stainless)
Stefan Junne, PhD, Associate Professor, Bioscience and Engineering, Aalborg University

• Definition and examples of hybrid processing
• Benefits for process flexibility and continuous operation
• Technical, logistical and regulatory burdens
• Sustainability considerations
• Will hybrid processing give a boost for single-use equipment beyond biopharma?

Advances in Recovery and Purification - Part 2

TABLE 3: Virus Clearance Strategies in Bioprocessing
Alois Jungbauer, PhD, Professor & Head, Biotechnology, Institute of Bioprocess Science and Engineering, BOKU University

• ICH Q5 A (R1) Revision: Viral safety Evaluation of Biotechnology
• Products Derived from Cell Lines of Human or Animal Origin Expectations
• What has changed and the Impact on bioprocessing
• Viral clearance strategies in continuous processing
• Virus removal

TABLE 4:  Optimizing Partnerships: Strategies for Effective CMO/CDMO Management in Bioprocessing
Tarik Senussi, PhD, Head of Technology Transfer, New Technologies, Recordati

• Defining Success Metrics: Key performance indicators for evaluating CMO/CDMO partnerships in bioprocessing projects
• Communication Strategies: Ensuring alignment through clear communication, project updates, and expectations management
• Risk Mitigation: Identifying and addressing common challenges such as quality assurance, timelines, and regulatory compliance
• Scaling and Innovation: Leveraging CMO/CDMO expertise to navigate scale-up/down challenges and integrate emerging technologies

Gene Therapy Manufacturing

TABLE 5: Viral Vector Manufacturing-From Niche Science to an Industry, Now with Those Growing Pains
Jack Cordrey, PhD, EMEA Senior Bioprocessing Applications Specialist, Purification & Filtration, Solventum

• Regulatory environment-today and future concerns.
• Cell line and productivity-triple transfection or stable cell line?
• Early impurity removal-its impact downstream
• Encapsulation-how do we tackle empty, partial, full, and genomic DNA?
• DNA Endonuclease addition-how confident are we that we can remove this CMC concern??

Intensified and Continuous Processing

TABLE 6: Integrated and Continuous Processing
Lara Fernandez-Cerezo, PhD, Associate Principal Scientist, Merck Sharp Dohme (MSD)

• Implementing advanced control process technologies to continuous processes
• Beyond monoclonal antibodies (mAb): applying continuous manufacturing to a diversified pipeline
• Breaking barriers to enhance adoption of continuous manufacturing: how?

TABLE 7: Sustainability in Biomanufacturing
Clare Thompson, Global Change Facilitator, BioPhophorum
Darryl Ratty, Executive Director, Global ESG, SK Pharmteco 

• Explore the main environmental concerns in biomanufacturing such as water use, plastics, and energy consumption
• Examine a structured framework that guides organizations in enhancing their sustainability practices
• Discuss specific measures that can be implemented by manufacturing facilities to minimize their environmental impact
• Critical environmental challenges in biomanufacturing and innovative solutions to address them

Next-Generation Analytical Methods

TABLE 8: Developability Assessment of Biotherapeutics - A Solved Problem or an Outstanding Challenge?
Hristo Svilenov, PhD, Associate Professor, TUM

• Common developability pitfalls for novel modalities (e.g., bispecifics, ADCs)
• Strategies for mitigating aggregation, instability, and immunogenicity
• Real-world constraints in applying developability frameworks
• Evolving regulatory expectations for developability data