Advancing Viral Safety with Next-Generation Sequencing: Regulatory Expectations, Validation, and Real-World Applications

Animal-based viral safety assays are facing growing challenges due to lengthy timelines, limited detection capabilities, and increasing regulatory scrutiny. Discover how next-generation sequencing (NGS) is transforming viral safety testing with faster, broader, and animal-free detection aligned with the latest ICH Q5A(R2) guidance. Join experts from WuXi Biologics to explore validated NGS approaches that enhance safety, support regulatory compliance, and advance modern biologics manufacturing.

Register Free: https://www.biopharminternational.com/bp_w/viral-safety

Event Overview:

Animal-based assays, while traditional, involve long timelines, limited detection scope, and increasing ethical and regulatory scrutiny. Next-generation sequencing (NGS) offers a rapid, more comprehensive alternative that supports animal-free testing aligned with the latest ICH Q5A(R2) guidance on viral safety.

WuXi Biologics has developed robust NGS methods capable of detecting adventitious viral contamination with exceptional sensitivity. Broad-spectrum coverage spans critical process materials, including cell banks, unprocessed bulk, drug substance, and final products. All methods are rigorously validated in accordance with ICH Q2, GMP standards, and global regulatory expectations. This technical advancement enhances product safety while addressing evolving priorities in biologics manufacturing.

Key Learning Objectives:

• Navigate new regulatory expectations for NGS adoption in viral safety.
• Implement effective NGS strategies for adventitious virus detection.
• Accelerate UPB release using NGS-driven testing approaches.

Who Should Attend:

• Quality professionals
• Process development scientists
• CMC leaders and specialists
• Manufacturing professionals
• Biopharmaceutical and biotechnology executives
• CRO and CDMO executives
• Consultants

Speaker:

Yuanshu Dong, PhD
Senior Director Biosafety Testing
WuXi Biologics

Yuanshu Dong leads the R&D department at WuXi Biologics Biosafety Testing Center and is responsible for testing method development and validation. Before joining WuXi Biologics, Dong worked as a research assistant professor and associate professor at Indiana University and Suzhou University, respectively. She earned a doctorate in cell biology from the University of Alabama at Birmingham.

Register Free: https://www.biopharminternational.com/bp_w/viral-safety