Breakout Discussions
Tuesday, 21 July, 15.15pm, CET
TABLE: Making Cell Culture More Physiological
Josephine C. Adams, PhD, Professor, Cell Biology, University of Bristol
- Laboratory cell culture is a central technology for investigating cell structure, physiology and the cellular basis of disease processes
- But many cell culture reagents and procedures remain the same as used in the 1950s!
- How can researchers embrace new resources to improve biological relevance and reproducibility of cell culture, along with the challenges that need to be overcome?
TABLE: Industry 4.0 and Process Analytical Technology: Where are We and Where Can We Go?
Mark Dürkop, PhD, Project Leader, Biotechnology, University of Natural Resources & Life Sciences, Vienna (BOKU); Co-Founder and CEO, Novasign GmbH
- Data storage, availability and integrity
- Latest automation implementations
- QbD strategies
- Latest sensor technologies – soft sensors
- Machine Learning for process development and optimization
- Model Predictive Control and real time release
TABLE: COVID Vaccine Manufacturing
Antonio Roldao, PhD, Head, Cell-based Vaccines Development Lab, Animal Cell Technology Unit, Instituto de Biologia Experimental e Tecnológica ( iBET)
Manuel JT Carrondo, Professor, Chemical & Biochemical Engineering, Univ Nova de Lisboa, IBET
- Unique Manufacturing Challenges for COVID Vaccines
- Technology Gaps
- DNA versus vector-based Production
- Upcoming Developments
TABLE: Digitalization and Big Data in Biopharma – vice or virtue?
Alois Jungbauer, PhD, Professor & Head, Biotechnology, Institute of Bioprocess Science and Engineering, University of Natural Resources and Life Sciences (BOKU)
Michael Sokolov, PhD, Lecturer, ETH Zurich; Co-Founder and COO, DataHow AG
Massimo Morbidelli, PhD, Professor, Department of Chemistry, Materials and Chemical Engineering, Politecnico di Milano
- Challenges in digitalization in biopharma versus available solution
- Added value expected from digitalization and big data analytics
- Requirements and decisions on team and infrastructure
- Application in Continuous Processing
TABLE: Manufacturing and Controlling Cell-based Manufacturing
Ali Mohamed, PhD, Vice President, CMC, Immatics US, Inc.
- Scaling up cell-based therapies
- Raw material, quality control, monitoring
- Vein to vein times, closed manufacturing
TABLE: Comparability for Cell and Gene Therapies
Fouad Atouf, PhD, Vice President, Global Biologics, USP
Florence Salmon, PhD, Portfolio Lead Regulatory Affairs CMC, Cell and Gene Therapies, Novartis Pharma AG
- Process changes and demonstrating comparability
- Coping with short development time frames
- Using surrogate material
- Determining the right assay panel
TABLE: Data Science as an Enabler for Good Data and Process Understanding
Christoph Herwig, PhD, Head Research Area Biochemical Engineering, TU Vienna
- How can data science improve analytical quality?
- Digital twins and data science workarounds for missing CQAs in control strategies
TABLE: Native MS in Biopharmaceutical Development
Dan Bach Kristensen, PhD, Principal Scientist, Symphogen
- How do you use native MS in biopharmaceutical development?
- What separation techniques do you couple to native MS?
- How robust is your native MS platform?
- Are you using native MS to study non-covalent interactions, and if yes, what kind of interactions?
- Do you see a role for native MS in QC (release testing according to specifications)?
Thursday, 23 July, 14.05
TABLE: Downstream Processing of Viral Vectors
Matthew Roach, Process Development Engineer, Precision BioSciences
- Purification methods for viral vectors
- Scale methods
- New purification technologies
TABLE: Testing Approaches for AAV vectors: Challenges and Specifications
Eduard Ayuso, DVM, PhD, Team Leader, Innovative Vectorology; Scientific Director Translational Vector Core (CPV), Translational Gene Therapy for Genetic Disorders, Inserm, University of Nantes
- Need for novel analytical tools
- Biological limits for upscaling viral vector manufacturing
- Vector genome titration
- Ratio of empty/full particles, Host Cell DNA, Aggregates
Table: Emerging Technologies for Biopharmaceutical Manufacturing
Dimitrios Lamprou, PhD, Reader in Pharmaceutical Engineering, Queen's University Belfast
- Examining additive manufacturing
- Benefits of electrospinning
- Microfluidics as a tool for drug delivery
- Delivering drugs with Microelectromechanical Systems (MEMS)