PLENARY KEYNOTE SESSION

BACK TO THE FUTURE OF BIOPROCESSING
ANTIBODIES TO EXTRACELLULAR VESICLES

What Have Monoclonal Antibodies Ever Done for Us? Past, Present, and Future Perspectives on Antibodies and How They Have Driven Bioprocessing Progress
Paul Varley, PhD, Senior Vice President, Development, Alchemab Therapeutics
Advances in bioprocessing have been pivotal to the emergence of monoclonal antibodies as one of the most successful classes of drugs in modern medicine. In this talk we will consider this journey and ask what's next for antibodies. We will also explore how advances in antibody bioprocessing continue to enable the next generation of biological medicines through the emergence of new product modalities.

Extracellular Vesicles as Promising Drug Modalities in Spinal Cord Injury and Other (Neuro)Degenerative Diseases
Eva Rohde, MD, Chair, Transfusion Medicine, Director GMP Unit, Spinal Cord Injury and Tissue Regeneration Center Salzburg (SCI-TReCS), Paracelsus Medical University Salzburg
Extracellular vesicles (EVs) have emerged as promising new biologic drug modalities. EV therapeutics (EV-Tx) from mesenchymal stromal cells (MSC) exert anti-inflammatory, anti-fibrotic and regenerative effects. MSC-EV-Tx could optimise healing after acute traumatic injury. Challenges in reproducible EV-Tx manufacturing prevent comprehensive evaluation of their efficacy. In early research, the paradigm of “the-process-is-the-product” is valid for complex biologicals. A “one-size-fits-all” approach to solve technical and regulatory issues is not available for EV-Tx. The claimed disease-related mechanisms of action (MoA) of candidate EV-Tx will determine regulatory requirements to be met. This presentation will introduce concepts to accelerate EV-Tx testing in various target diseases.

Biographies

Paul Varley, PhD, Senior Vice President, Development, Alchemab Therapeutics
Dr. Varley is an expert in biopharmaceutical development with more than 30 years' experience developing antibodies, proteins, and other macromolecules into drugs from research into the clinic and through to commercialization. Paul is currently Senior Vice President, Development, at Alchemab Therapeutics. Previously Paul held similar roles in Cambridge Antibody Technology, Astra Zeneca, MedImmune, and Kymab. Previously Paul had also worked at British Biotech, the UK National Institute of Biological Standards and Control (NIBSC), and the U.S. National Institutes of Health. Dr. Varley holds a degree in Biomolecular Sciences (First Class) from Portsmouth Polytechnic and a PhD in Biochemistry from the University of Newcastle upon Tyne. Paul was until recently a member of the British Pharmacopeia (BP) Commission and Chair of BP Expert Advisory Group on Biological and Biotechnological Products (2013 – 2022). He also currently chairs a MHRA/BP working party on new standards for Biological Medicines (DPS) and is also a member of the European Pharmacopeia (EP) Expert Committee on Monoclonal Antibodies.

Eva Rohde, MD, Chair, Transfusion Medicine, Director GMP Unit, Spinal Cord Injury and Tissue Regeneration Center Salzburg (SCI-TReCS), Paracelsus Medical University Salzburg
Eva Rohde, MD, is Head of the Clinical Department of Transfusion Medicine at the University Hospital Salzburg, Austria, and Director of the first academic pharmaceutical manufacturing unit for stem cell- and extracellular vesicle-based therapeutics in Europe. Her research at the Paracelsus Medical University (PMU) in Salzburg focuses on the clinical application of stem cell-based therapies with a special emphasis on their extracellular vesicles (EVs). The overarching goal is to develop novel cell-free therapies in conjunction with scientifically solid application-oriented analytical technologies. Eva Rohde actively participates in a global network of academic and industrial partners with the goal of the clinical development of EV-based therapies in diseases with a high unmet need. Eva Rohde chairs the global “Task Force on Regulatory Affairs and Clinical Use of EV-based Therapeutics” of the International Society for Extracellular Vesicles (ISEV) and is a member of the ISCT Exosome Committee.

Track Keynotes and Featured Speakers

Peter Herr Neubauer, PhD, Lab Head, Bioprocess Engineering, TU Berlin

David C. James, PhD, Professor, Bioprocess Engineering, University of Sheffield

Martina Micheletti, PhD, Professor, Bioprocess Fluid Dynamics, University College London

Cecile Brocard, PhD, Director Downstream Development, Bioprocess Science, Boehringer Ingelheim RCV GmbH & Co. KG

Andreas H. Laustsen, PhD, Center Director & Professor, Center for Antibody Technologies, DTU Bioengineering, Technical University of Denmark

Birgit Wiltschi, PhD, Head of Synthetic Biology Group, ACIB GmbH & University of Natural Resources and Life Sciences, Vienna

Jonathan Bones, PhD, Principal Investigator, Characterisation and Comparability Laboratory, National Institute for Bioprocessing Research and Training (NIBRT), Ireland in between

Markus Haindl, PhD, Global Head, Gene Therapy Technical Development, Roche Diagnostics GmbH

Patrick M. Hossler, PhD, Senior Director, Pharmaceutical Development, Ultragenyx

Parameswari Govindarajan, PhD, Senior Scientist, Process Development, CSL Behring GmbH

Sandra Krause, Lab Engineer, Biodevelopment Microbial Platform, Sanofi

Antonio G. Cardillo, PhD, Scientific Lead Associate Director, TRD-DS Global Innovation Centre, GSK Vaccines

Sarah Snykers, PhD, Director of Operations, Legend Biotech

Ali Mohamed, PhD, Vice President, CMC, Immatics US, Inc.

Ricardo Gomes, PhD, Senior Researcher, Mass Spectrometry Unit, iBET—Instituto de Biologia Experimental e Tecnológica

Thomas Waerner, PhD, Senior Principal Scientist & Laboratory Director, Analytical Development & Quality Control, Boehringer Ingelheim Pharma GmbH & Co. KG

Stefan Braun, Head of Laboratory, Liquid Formulation R&D, Merck

Iris L. Batalha, PhD, La Caixa Junior Leader, Molecular Bionics, Institute for Bioengineering of Catalonia (IBEC)

Petra Hanga, PhD, Lecturer, Biochemical Engineering and Cellular Agriculture, University College London

Joachim Schulze, PhD, CTO, Planetary Group

Seren Kell, Senior Science and Technology Manager, The Good Food Institute Europe

John Morrissey, PhD, Professor, Microbiology, University College Cork