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Charles River 7th Annual Viral Safety and Viral Clearance Summit

October 3 @ 8:00 am - October 4 @ 5:00 pm

Charles River Laboratories and Wheeler Bio Announce Agreement to Build and  Operate RightSourceSM Laboratory | Business Wire

Join us for a two-day event uniting experts on viral safety and viral clearance taking place at the Hyatt Centric Fisherman’s Wharf in San Francisco, CA. Gain insight from expert regulatory authorities, academic researchers, and industry leaders who are defining the way we evaluate biologics, vaccines, and advanced therapeutic medicinal products (ATMPs). Discover new technologies, learn best practices, and achieve a solid understanding for designing an efficient manufacturing process. Charles River reserves the right to refuse registrations from market competitors at our own discretion.


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


October 3 @ 8:00 am
October 4 @ 5:00 pm
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Hyatt Centric Fisherman’s Wharf San Francisco
555 North Point St
San Francisco, CA 94133 United States
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