Confirmed Presentations – Day One
Current Perspectives on NGS for Detection of Viral Adventitious Agents in Biologics – Arifa S. Khan, PhD, FDA/CBER (invited)
Analysis Matters: Practical Bioinformatics for NGS-based Virus Safety Testing – Shawn Polson, Director, UD Bioinformatics Data Science Core Facility, University of Delaware
Head to head comparison of NGS and in vivo viral safety testing – a short summary of the publication – Horst Ruppach, Charles River
GMP is Not for the Faint of Heart – Colette Côté, PhD, Pathoquest
Panel: NGS becomes mandatory with the release of ICH Q5A R2 end this year? – Various Panelists
Strategizing Digital Transformation of Viral Clearance Database – Melissa Nathlich, Amgen
Automation of Virus Infectivity Assays for Virus Clearance Studies – from sample titration to readout – Eleonora Widmer, MD, PhD, CSL
Utilizing Viral Surrogates to Evaluate Viral Clearance for Multiple Modes of Separation – David A. Cetlin,Cygnus Technologies
Confirmed Presentations – Day Two
Multi-Spike Presentation – Madison Gaiser, Charles River
Anion Exchange in Viral Clearance for Biologics: A Comparison of Membrane Chromatography and Column Chromatography – Paul Phelan, Joinn Biologics
Current approaches and considerations for viral clearance in cell and gene therapy (CGT) – Tareq Jaber, PhD, Charles River
Application of Prior Knowledge in Early-Stage Viral Clearance Generic Claims – Valerie Cusick, Regeneron
Viral Clearance of IsoBlock Membranes and its Dependence on Surface Chemistry – Daniele Gerion, TeraPore
Evaluation of the Viral Clearance Capability of the Emphaze Filter – Serge Monpoeho, Regeneron
Examining the Effects of Variable Pressure Conditions on Viral Clearance of Planova Filters – Tsion Akalu, Asahi Kasei Bioprocess America, Inc.
Impact of ICH Q5A Revision 2 on VC study design – Various Panelists