Metagenomic Analysis for Viral Risk Assessment of Live Viral Vaccines in a GMP-Compliant Application

In this webinar, Vanessa Sarathy, Associate Principal Scientist from MSD Research Laboratories, focuses on the application of NGS for virus detection in biopharmaceuticals using viral metagenomic analysis (VMA), with an increasing recognition of NGS as a biosafety testing tool by regulatory authorities. She provides an overview of the typical VMA steps, ranging from sample processing to bioinformatics analysis. Then she proceeds to the next section of her talk, where she presents a case study comparing various bioinformatics tools for NGS-based biosafety analysis. The study assessed the tools' total hits, breadth of genome coverage, and detection of spiked-in viruses, revealing similar detection limits and performance. Vanessa concludes by emphasizing the need for further automation in several types of NGS-based analyses to facilitate GMP assays. 

This talk was given as part of the regular Open Forums on NGS-based QC for advancing drug development and manufacturing, hosted by Genedata Selector^®. 

Who should watch? 

Biopharma and biotech professionals looking to advance analytical development, biosafety, and QC testing for CGT products by embracing digitalization and innovative enterprise data analysis systems.