Traditional in vivo assays are slow, resource-intensive, and increasingly unnecessary. Recent updates to the ICH Q5A guideline make it clear that regulators are ready to support smarter, faster, and more comprehensive approaches to viral detection.
Next generation sequencing (NGS), specifically agnostic transcriptomic approaches, has emerged as a compelling alternative for adventitious agent testing. With broad detection capabilities, proven sensitivity, and increasing regulatory recognition, NGS is reshaping how virus safety is done across biologics development.
In this expert-led webinar, Charles River Biologics specialists Olaf Stamm, PhD, and Horst Ruppach, PhD, will address common questions about NGS in viral safety testing. They outline where it fits, what it replaces, and how to implement it effectively within regulatory expectations..
Dr. Horst Ruppach, Ph.D.
Executive Director, Scientific and Portfolio, Global Biologics Charles River Biologics
Dr. Horst Ruppach studied chemistry at the University of Cologne and the University of Marburg, Germany and earned his PhD in Virology (HIV) at the Georg Speyer House, Frankfurt. He has 25 years of experience in the field of virology. His scientific, technical, and regulatory expertise is in pathogen safety testing and virus/prion clearances studies for all kind of Biologics including Cell- and Gene Therapy products and medical devices.
Olaf Stamm, Ph.D., MDRA
Technical Business Development Director Charles River Biological Testing Solutions
Dr. Stamm holds a doctoral degree in molecular parasitology and a master degree in drug regulatory affairs from the University of Bonn, Germany. He joined Charles River in 2003 and became responsible for the Business development activities in Europe and Asia.Prior to joining Charles River he worked for Eurofins Scientific running their microbiological GMP testing laboratories in Switzerland.