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
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
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.