互动式分组讨论

互动式分组讨论是一种非正式的、有主持的讨论类型。参与者可以交流彼此的想法和经验,并就特定主题建立未来的合作。每次讨论都将由一名主持人主持,他将确保讨论步入正轨并确保小组参与。为了充分利用这个机会,请准备好分享您的研究范例,参与集体解决问题的会议,并热烈分享您的想法。

互动分组讨论仅限面对面方式进行。

3月19日(四) 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

* 活动内容有可能不事先告知作更动及调整。

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