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Smarter, Faster Viral Detection: The Case for NGS
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 viral safety testing is performed across biologics development.
In this expert-led webinar, Charles River biologics specialists Olaf Stamm, PhD, and Horst Ruppach, PhD, 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.
What you will learn:
- When and how to replace in vivo assays and virus-specific PCR panels using transcriptomic NGS while maintaining compliance
- Why agnostic NGS is a strategic solution for high-risk scenarios involving limited sample volumes, neutralizing antibodies, or unknown contaminants
- What developers need to align with revised ICH Q5A guidance and reduce delays tied to legacy testing models
Who should watch:
- R&D, Process Development & Bioprocessing, MAbs scientists
- Quality, Analytics, Regulatory & Compliance
- Manufacturing, Operations & Supply Chain
- C-levels, Operations & Supply Chain and other related fields
Webinar Presenters
Horst Ruppach, PhD
Executive Director, Scientific and Portfolio, Global Biologics Charles River Biologics
Charles River
Olaf Stamm, PhD, MDRA
Technical Business Development Director Charles River Biological Testing Solutions
Charles River