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)