Fundamentals and Regulatory
(Chair: Thomas Kreil Ph.D., Associate Professor of Virology, Vice President, Global Pathogen Safety, Takeda)
New chapter in the European Pharmacopeia on high-throughput sequencing for the detection of viral extraneous agents
Johannes Bluemel, Ph.D.
Head of Viral Safety Section, Infectiology, Paul-Ehrlich-Institute
Enhancing Viral Safety: Prior knowledge and platform virus clearance strategies in the era of ICHQ5A (R2)
Andy Bailey, Ph.D.
CEO, ViruSure GmbH
Implications of the ICHQ5A (R2) on viral clearance studies scopes
Anja Tessarz, Ph.D.
Associate Director R&D, SME Viral Clearance, Charles River Laboratories Germany GmbH
Nanofiltration of challenging plasma derived proteins
(Chair: Elisa Moretti, PhD., Senior Director Global Pathogen Safety/Global Manufacturing Science & Development (GMSD), Kedrion Biopharma)
Robustness study of Planova S20N (TBC)
Changes in nanofilters: case studies for switching to state-of-the-art nanofilters in established and developing manufacturing processes
Martyn Paddick, Ph.D.
Director Global Process Development & Industrialization, Kedrion Biopharma
Mechanistic Insights into Virus Filtration Process by Direct Visualization of Retention Profiles
Remo Leisi, Ph.D.
Head of Breakthrough Technologies & Technical Innovation, CSL
Rapid nanofiltration enabling highly efficient processing
(Chair: Uwe Gottschalk, PhD., Operating Partner, Keensight Capital former Lonza CSO)
Evaluation of Planova FG1 Virus Filter: Enhancing Efficiency and Addressing Filterability Challenges in a Diverse Therapeutic Antibody Pipeline
Ludivine Profit
Scientist, Purification Process Development, Sanofi
Evaluation of Planova S20N on a challenging mAb solution prone to aggregation (TBC)
Evaluation of Planova FG1 (TBC)
Cell Culture Clarification with Tangential Flow Microfiltration
(Chair: Ashley Baltes, Scientific Director, Just-Evotec Biologics, Inc)
Cell Culture Clarification with Tangential Flow Microfiltration in a perfusion production (TBC)
Intensification Strategies for Adeno Associated Virus Production Processes
Thomas Villiger, PhD.
Professor of Bioprocess Technology, University of Applied Sciences and Arts Northwestern Switzerland
FHNW
Optimizing TFF Hollow Fiber Filtration for Scalable Perfusion Bioprocessing
Patrick Romann, Ph.D.
Bioprocess Innovation Manager, R&D, Levitronix
New Trends and Applications
(Chair: Alex Harley, SME – Viral Clearance, Downstream Process Development, FUJIFILM Biotechnologies)
Media nanofiltration for Advanced Therapy Medicinal Products (ATMP) (TBC)
Exploring the Approach for rAAV Downstream Early-Stage Viral Clearance Study
Yu-Tsan (Richard) Liu
Senior Scientist, Gene Therapy Process Sciences Downstream, UCB Pharma SA
Evaluation of Viral Filter Performance in an End-to-End Continuous Process
Jodi Chen
Scientist, Purification, PD, Just-Evotec Biologics
Poster Session
Study of Superior Microfiltration Membrane Structure for Perfusion Cell Culture: Influence of Cell Density and Shear at Membrane Surface on Filtration Performance
Shun Matsuda, Scientist, Research and Technology Development Div., Asahi Kasei Life Science Co., Ltd.
Non-Pressurized Membrane Concentration for Pharmaceutical Manufacturing: Forward Osmosis and Membrane Distillation
Junji Sakuda, Ph.D.
Manager, Corporate Research & Development., Asahi Kasei Corporation
The features of membrane structure and production method of BioOptimal UMP
and MFSL filters
Yuki Miki
Chief Researcher, Microza Research ＆ Development Department., Asahi Kasei Corporation
Hybrid PCR-Based Mycoplasma Detection for Product-Specific Suitability and USP<63> Comparability for High Cell Density Products
Lori Daane, PhD
Chief Scientific Officer, Bionique Testing Laboratories LLC
A comparison of Planova FG1 virus filter performance and product quality on various modalities of biologics
Minni Aswath
Vice President, Process Development., Bionova Scientific LLC
GMP Implementation of Oxford Nanopore’s long-read sequencing technology for
the detection of adventitious viruses in biopharmaceutical products
Hans-Peter Fasching
Deputy Head of Molecular Biology Department, ViruSure GmbH