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SUMMARY:FDA Scientific Public Workshop: Next-Generation Sequencing for Adventitious Agent Detection in Biologics
DESCRIPTION: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. \nNGS-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: \n\nViruses\nBacteria\nFungi\nMycoplasma\nParasites\n\nThe 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. \nWorkshop Objectives: \n\nFacilitate scientific exchange among key stakeholders and regulators regarding current advances in NGS technology and their application to AA detection in biological products.\nGather perspectives on existing methodologies\, implementation challenges\, and emerging technical requirements for NGS-based AA detection.\nUnderstand challenges associated with the adoption of NGS-based methods\, including analytical validation\, data interpretation\, and integration into existing safety testing frameworks.\nIdentify knowledge gaps that must be addressed to support the broader application of NGS-based methods for ensuring the safety of biological products.\n\nVisit the event page for more information.
URL:https://about.citiprogram.org/event/fda-scientific-public-workshop-next-generation-sequencing-for-adventitious-agent-detection-in-biologics/
LOCATION:Online
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DTSTART;TZID=America/New_York:20260923T130000
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SUMMARY:Town Hall – Biocompatibility and Chemical Characterization Testing - Extractions
DESCRIPTION:The U.S. Food and Drug Administration (FDA) will host a town hall for industry professionals and other interested stakeholders to discuss chemical characterization testing methodologies used to address biocompatibility endpoints for medical devices. The session will focus on approaches for conducting extractions for chemical characterization testing in accordance with ISO 10993-18\, while also highlighting common challenges and practical examples related to these testing processes. \nParticipants will explore considerations for evaluating the potential biological response to device materials within a risk-based framework. Discussions will also address FDA’s ongoing efforts to support biocompatibility assessments in a manner that is intended to be efficient and least burdensome for both medical device manufacturers and regulatory reviewers. \nVisit the event page for more information.
URL:https://about.citiprogram.org/event/town-hall-biocompatibility-and-chemical-characterization-testing-extractions/
LOCATION:Online
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