Webinar 3: Reference Materials for HTS/NGS-Based Adventitious Virus Detection

Teams / 12:00-14:00 CET
10th November 2026

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Biological Reference Materials (BRM) Webinar Series – Three-Part Webinar Series 

Purpose of the Webinar Series

Co-hosted by the Animal-Free Safety Assessment Collaboration (AFSA) and endorsed by the International Alliance for Biological Standardization (IABS), this webinar series will increase awareness and practical understanding of biological reference materials and their role in supporting the transition from in vivo to in vitro methods for vaccine release testing. This webinar series will present the following: 

  • Case studies that illustrate how reference standards can support implementation of in vitro methods across different vaccine products and technologies 
  • Regulatory expectations during method transitions 
  • Real-world examples on the use of appropriate reference standards, including guidance for situations where no reference standard or material yet exists 

Series Overview  

The series is designed to move participants from foundational concepts to applied examples, connecting regulatory expectations with practical approaches for adopting in vitro methods in vaccine release testing.

Webinar 1 introduces core principles and regulatory considerations, illustrated through DTaP and Hepatitis B examples. Watch the recording here.

Webinar 2 focuses on reference material lifecycle management and transition planning, using Rabies and tick-borne encephalitis (TBE) case studies. REGISTER

Webinar 3 examines the use of reference viruses for next-generation sequencing (NGS)-based adventitious virus detection.

Pre-read Material

MaterialLink
ICH Q5A (R2) VIRAL SAFETY EVALUATION OF BIOTECHNOLOGY PRODUCTS DERIVED FROM CELL LINES OF HUMAN OR ANIMAL ORIGIN
IABS 4th NGS conference reportReport of the fourth conference on next-generation sequencing (NGS) for adventitious virus detection in biologics for humans and animals: Validation and implementation of NGS
EDQM WebinarFrom text to practice: high-throughput sequencing for the detection of extraneous agents under Ph. Eur. general chapter 2.6.41 (Register to watch the recording)
EDQM Ph. Eur. Chapter 2.6.41High-throughput sequencing for the detection of viral extraneous agents in Ph. Eur. Issue 12.2 (October 2025) (need a license to access)
WHO Recommendations/ GuidelinesRecommendations for the evaluation of animal cell cultures as substrates for the manufacture of biological medicinal products and for the characterization of cell banks, Annex 3, TRS No 978

Scientific principles for regulatory risk evaluation on finding an adventitious agent in a marketed vaccine, Annex 2, TRS No 993

A Collaborative Study to Evaluate the Proposed First WHO International Reference Panel for Adventitious Virus Detection in Biological Products by High-throughput Sequencing (HTS) Technologies

Agenda

Time (CET)SessionSpeaker
12:00–12:05Welcome & Session ObjectivesJanette Turner, Humane World for Animals
Bio
12:05–12:30HTS/NGS for Adventitious Agents: A Regulatory OverviewLaurent Mallet, European Directorate for the Quality of Medicines & HealthCare
Bio
12:30–12:55Reference Materials for NGS Implementation as a New Approach Methodology for Adventitious Virus DetectionArifa Khan, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration
Bio
12:55–13:15Implementing NGS for adventitious virus detection in a live virus vaccineLeyla Diaz, MilliporeSigma BioReliance® Testing Services
Bio
13:15–13:35HTS for adventitious virus detection : reference materials considered throughout Sanofi vaccine test set upCarine Logvinoff, Sanofi
13:35–13:55Panel Discussion / Q&AModerated by Humane World for Animals
13:55–14:00Series Wrap-UpJanette Turner, Humane World for Animals