インタラクティブブレイクアウトディスカッション

インタラクティブブレイクアウトディスカッションは、非公式かつモデレートタイプのディスカッションです。参加者はアイデアや経験を交換し、特定のトピックについて、将来のコラボレーションを築くことができます。各ディスカッションは、ファシリテーターの進行によって、グループが維持されます。この機会を最大限に活用するには、自分の研究例を共有し、集団で問題解決を行うセッションに参加し、活発なアイデアを共有する準備をしてきてください。

インタラクティブブレイクアウトディスカッションは 対面でのみ行われます。

3月19日（水） 18:00 - 18:30

Cell Culture and Cell Line Engineering - Part 2
細胞培養・細胞株エンジニアリング - パート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
回収・精製の進歩 - パート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
遺伝子治療の製造

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
強化処理・連続処理

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
次世代の分析法

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