Breakout Discussions

Table 1: Process Robustness, Challenges and Validation Strategies

Moderator: Christoph Herwig, PhD, Professor and Head, Biochemical Engineering, Chemical Environmental and Bioscience Engineering, Technical University of Vienna (TU Wien)

• How to judge that a process is robust?
• Is perfusion a robust process
• How to demonstrate manufacturing capability inside of CPV by data science tools
• How to find root causes for process variability

Table 2: Problem Solving through Genome Engineering

Moderator: Bjørn Voldborg, MSc, Director, CHO Cell Line Development, The Novo Nordisk Foundation Center for Biosustainability, Technical University of Denmark (TU Denmark)

• Which problems can and which cannot be solved by genome engineering?
• Which genome engineering tools are being used?
• Which problems have been solved?

Table 3: Bioprocessing Data Science –Where are the Training Gaps and What will be the Perceived Benefits?

Moderator: Ronan O’Kennedy, PhD, Consulting Bioprocess Specialist, ROK Bioconsulting

Table 4: Continuous Processing

Moderator: Alois Jungbauer, PhD, Professor, Department of Biotechnology, University of Natural Resources and Life Science, Vienna, Austria and Austrian Centre of Industrial Biotechnology

• Process control in biomanufacturing
• How to tackle process development for continuous biomanufacturing

Table 5: Process Control for Continuous Processing

Moderator: Margit Holzer, PhD, Owner, Ulysse Consult

• Control strategies and monitoring technologies
• Process validation
• Impact of Digitalization, Industry 4.0

Table 6: CMC and Regulation of Cell-based Therapies

Moderators:
Matthias Renner, PhD, Scientist, Federal Institute for Vaccines and Biomedicines, Paul Ehrlich Institute
Florence Salmon, PhD, Director Regulatory Affairs CMC, Novartis Pharma AG

• Most common questions asked by companies/ regulators
• Process change and comparability
• Challenges around gene-edited cell therapies
• Preparing for filing– What are the priorities, preclinical packages?

Table 7: Cell Therapy Scale Up

Moderators:
Paula M. Alves, PhD, CEO, IBET; Director Animal Cell Technology Unit, ITQB NOVA
Robert Deans, PhD, CTO, Bluerock Therapeutics

• Current challenges in cell-based manufacturing
• Emerging technologies
• Reducing COGs

Table 8: Analytics in Gene Therapy

Moderator: Eduard Ayuso, DVM, PhD, Team Leader, Innovative Vectorology; Scientific Director Translational Vector Core (CPV), Translational Gene Therapy for Genetic Disorders, Inserm, University of Nantes

• In process analytics: limitations
• Release testings: early phase vs late phase
• Need for novel analytical tools

Table 9: Needs for Analytical Methods in Gene Therapy Vector Characterization

Nina Forsberg, Marketing Director, Vironova

• Challenges to meet regulatory and safety requirements in emerging therapies such as gene therapy
• Current CMC guidelines - strengths and limitations and need for further detail
• How to interpret and correlate data from different analytical methods - are established methods sufficient or are novel analytical solutions needed?
• Risks to consider when relying in traditional methods versus investing in innovative technology - choosing the right collaborations partner.