FDA Scientific Public Workshop: Next-Generation Sequencing for Adventitious Agent Detection in Biologics
The FDA’s Center for Biologics Evaluation and Research (CBER) will host a virtual scientific public workshop on September 23, 2026, titled “Next-Generation Sequencing (NGS) for Adventitious Agent (AA) Detection in Biologics.” The event will bring together subject matter experts and stakeholders to discuss the readiness of NGS technologies for AA detection, examine current challenges, and explore potential approaches to support broader adoption of NGS-based methodologies in biological product testing.
NGS-based AA detection methods are emerging as new approach methodologies (NAMs) that can help enhance the safety of biological products while reducing reliance on animal testing. Workshop discussions will focus on the use of NGS technologies to detect a broad range of adventitious agents, including:
- Viruses
- Bacteria
- Fungi
- Mycoplasma
- Parasites
The event will also address challenges associated with detecting adventitious viruses, particularly given the genetic diversity of viral populations and the ongoing emergence of new viral variants. These topics are relevant to a range of CBER-regulated biological products, including cell and gene therapies, xenotransplantation products, blood products, and vaccines.
Workshop Objectives:
- Facilitate scientific exchange among key stakeholders and regulators regarding current advances in NGS technology and their application to AA detection in biological products.
- Gather perspectives on existing methodologies, implementation challenges, and emerging technical requirements for NGS-based AA detection.
- Understand challenges associated with the adoption of NGS-based methods, including analytical validation, data interpretation, and integration into existing safety testing frameworks.
- Identify knowledge gaps that must be addressed to support the broader application of NGS-based methods for ensuring the safety of biological products.
Visit the event page for more information.