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.

Wednesday, 19 March, 2025: 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