Adventitious agent screening by long-read NGS

Abstract Long-read nanopore sequencing — a powerful and rapid platform with a small footprint — is ideal for metagenomic applications and will open a new frontier in compendial testing. This presentation highlights the unique challenges for implementing a long-read sequencing approach in a GMP quality control setting to perform virus screening in biological drug products. These challenges encompass the bioinformatic analysis validation (speed, cost, computer resources, accuracy, and database issues), sample preparation, positive and negative assay controls, criteria for true positive and subsequent confirmatory tests, and minimizing the percentage of unmapped reads. Addressing these obstacles is vital for successfully advancing and integrating this technology as a robust assay for product testing. Biography Serge Monpoeho holds a PhD and PharmD in virology. He obtained his PhD from the Pharmacy School of Nantes in France. Serge assumed a virology laboratory manager role at Genentech in 2003 before joining Regeneron in 2012 as a product Viral Safety Manager. He is currently assuming the position of Executive Director & Chief Virologist in Quality Control at Regeneron IOPS. In his current role, Serge is responsible for overseeing the viral safety programs for both mAb and gene therapy products, as well as supporting other activities of ATMP manufacturing and testing.