Next Generation Sequencing in Adventitious Agent Testing
Smarter, faster viral detection: the case for NGS
Two Charles River Biologics specialists answer the questions developers keep asking about
agnostic transcriptomic NGS: where it fits, what it replaces, and how to put it in front
of a regulator with confidence.
An agnostic run maps everything in the sample and then makes you account for whatever is left.
A virus-specific PCR panel only answers the question you already knew to ask, which is the
gap this session is about.
The session
Regulators have moved. Most testing strategies have not.
Agnostic transcriptomic next generation sequencing has become a credible alternative for
adventitious agent testing, with broad detection, proven sensitivity and growing regulatory
recognition. ICH Q5A(R2) now encourages NGS as a replacement for in vivo assays,
because it addresses the limits of breadth and sensitivity those assays carry, and because
it supports the wider objective of reducing animal testing. What is less settled inside most
organisations is the practical question: which assays come out of the package, which stay,
and what a reviewer will expect to see.
When and how
When and how to replace in vivo assays and virus-specific PCR panels using
transcriptomic NGS while maintaining compliance.
Why
Why agnostic NGS is a strategic solution for high-risk scenarios involving limited
sample volumes, neutralizing antibodies, or unknown contaminants.
What
What developers need to align with revised ICH Q5A guidance and reduce delays tied to
legacy testing models.
Presenters
Charles River Biologics
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 virology. His scientific, technical and
regulatory expertise covers pathogen safety testing and virus and prion clearance studies
for all kinds of biologics, including cell and gene therapy products and medical devices.
By expanding his expertise to the analytical characterization and testing required for
biologics from the clinical phase through to commercialization, he took on the scientific
leadership role at Charles River Biologics in 2019. He supports and coordinates global
analytical service development and actively manages the Charles River Biologics testing
portfolio.
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's degree in drug
regulatory affairs from the University of Bonn, Germany. He joined Charles River in 2003
and became responsible for business development activities in Europe and Asia. Before
joining Charles River he worked for Eurofins Scientific, running their microbiological GMP
testing laboratories in Switzerland. For many years the global subject matter specialist
for impurity and contamination testing, he now focuses on analytical and regulatory
consulting for Charles River Biologics Services in Asia and Europe.
Watch on demand
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Full recorded session with both presenters
Replaces in vivo assays and PCR panels: what to keep, what to retire
ICH Q5A(R2) expectations in practice
Optional consultation with a Charles River expert
Presented on BioSpectrum Asia
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Next Generation Sequencing in Adventitious Agent Testing
