An important aspect of viral safety assurance for biologics is a panel of orthogonal virus detection assays performed during cell line characterization. Increasingly, regulations are being updated to recommend the use of molecular methods for biosafety testing, especially to replace outdated animal-based testing.
In this context, the correct selection of assays is critical to retain sufficient breadth of virus detection and sensitivity to mitigate the risk of contamination events. In this webinar, we explore the use of non-targeted next generation sequencing (NGS), combined with targeted molecular methods, to encompass a suitable range of viruses to meet specific regulatory expectations.
In this webinar, you will learn:
- What regulators expect from your cell line characterization package for adventitious virus testing
- Different methods employed in targeted and non-targeted approaches
- How our orthogonal NGS approaches comply with ICH Q5A(R2) and other recent regulatory updates
- How molecular methods can support sustainability and 3R initiatives by replacing animal testing
Speakers

Anna Woodward, Ph.D.
Merck
Technical Consultant
Anna Woodward joined Merck in 2019 and has more than 15 years of experience providing technical support to developers and manufacturers of small molecules and biologics. In her current role as a technical consultant, Anna supports the BioReliance® services portfolio and works closely with clients and internal colleagues to provide scientific and regulatory guidance on biosafety testing packages. Anna holds a Ph.D. in cell biology from the University of Dundee, Scotland.

Leyla Diaz, Ph.D.
Merck
Technical Consultant
Leyla is a principal scientist in field development services. She provides scientific and regulatory input in biosafety testing and characterization of biological therapeutic products. She has 17 years of industry experience in product development of therapeutic antibodies and assay development for large molecules and vaccines.
Pharma and biopharma manufacturing
- Pharma and biopharma manufacturing
Duration:1h
Language:English
Session 1:Tue, July 29, 2025 4:00 PM CEST
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