FDA CBER Convenes NGS Workshop on Biologics Detection Standards

Biologics manufacturers operating under 21 CFR Part 610 and ICH Q5A(R2) face a clear regulatory signal: CBER is actively shaping the framework for next-generation sequencing as a validated adventitious agent detection methodology. On September 23, 2026, FDA's Center for Biologics Evaluation and Research will convene a full-day virtual scientific public workshop titled "Next-Generation Sequencing for Adventitious Agent Detection in Biologics," drawing subject matter experts from CROs, academic virology, and CBER's own Office of Therapeutic Products.

The workshop's stated objectives go beyond technology demonstration. CBER is specifically seeking to map analytical validation gaps, data interpretation challenges, and integration pathways into existing safety testing frameworks, the precise pressure points QA directors and regulatory affairs leads encounter when qualifying new approach methodologies against legacy compendial assays. The agency's January 2024 adoption of ICH Q5A(R2) already signaled intent; this workshop operationalises that intent by gathering industry perspectives on where implementation stalls.

Adventitious agent contamination, spanning viruses, bacteria, fungi, mycoplasma, and parasites, carries direct consequences for cell and gene therapies, xenotransplantation products, blood products, and vaccines regulated by CBER. Viral detection presents the sharpest technical challenge: sequence diversity within viral populations drives continuous emergence of variants and novel agents that conventional in vivo and in vitro assays may not reliably capture. NGS-based methods, positioned here as new approach methodologies, offer broader detection coverage while reducing dependence on animal testing, an alignment that intersects with both scientific and regulatory modernisation priorities.

Session structure reflects the agency's intent to stress-test readiness across the supply chain. CBER's internal perspectives open the day, led by Arifa Khan from the Molecular Retrovirology Unit and Sandip De from the Office of Cellular Therapies. A dedicated CRO session follows, featuring representatives from BioReliance, ViruSure, and PathoQuest, organisations already offering commercial NGS testing services, giving plant heads a direct read on where contract testing capability currently sits relative to regulatory expectation.

Registration for the Microsoft Teams session is closed at capacity; a YouTube livestream remains accessible, and a recording will be posted to FDA.gov following the event. An updated agenda is expected closer to the date.

The knowledge gaps CBER identifies through this workshop are likely to inform future guidance language on NGS analytical validation requirements, making the post-event publication on FDA.gov a document QA and regulatory teams should track against their own method qualification timelines.

Source: FDA Center for Biologics Evaluation and Research via What's New – Vaccines, Blood & Biologics RSS Feed, September 1, 2026. Workshop date: September 23, 2026, 8:30 a.m.–5:00 p.m. ET, virtual via Microsoft Teams.