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Bulk harvest release testing for adventitious viruses is an integral part of biosafety for manufacturing biopharma products. Finding a testing strategy that works for diverse biologics modalities continues to be a critical requirement. Recently, the field has moved toward next-generation sequencing (NGS), which addresses limitations of current testing strategies, including cell culture and PCR assays. This interest is also bolstered by regulatory changes that favor NGS adoption for adventitious agent testing.
In this GEN webinar, our expert speakers will provide an overview of the current state of NGS-based release testing for biosafety and discuss how a GMP-compliant process can increase biologics manufacturing speeds and improve product safety. They will showcase the advantages of NGS-based release testing, including its broader detection range and greater accuracy compared to cell cultures and PCR assays. Attendees will learn strategies for optimizing NGS-based testing for a range of biologics, including monoclonal antibodies, cell therapies, viral vectors, and vaccines. Key takeaways from the webinar are:
- How NGS enhances bulk harvest testing for adventitious viruses
- Steps to implement a GMP-compliant NGS workflow in biomanufacturing
- Regulatory trends driving NGS adoption in bulk release testing
A live Q&A session will follow the presentation, offering you a chance to pose questions to our expert panelists.
