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Webinar: Applying next-generation sequencing for vaccine development and testing

Next-generation sequencing (NGS) is a powerful, high-throughput technology that enables rapid and comprehensive analysis of genetic material, offering unparalleled sensitivity for detecting known and unknown contaminants, verifying product integrity, and supporting regulatory compliance.

This webinar discusses the practical applicability of NGS sequencing for vaccine development and testing by low- and middle-income country manufacturers (LMICs). This two-day webinar provides up-to-date information and guidance from subject matter experts on NGS methodology, validation, regulatory expectations, and controls. It features two real-world case studies and a panel discussion between regulatory experts.

Speakers include:

  • Kutub Mahmood, PhD, Project Director, Polio Vaccines, Center for Vaccine Innovation and Access, PATH
  • Tara Tagmyer, PhD, Scientific Director, Bacterial & Parasitic Diseases, Center for Vaccine Innovation and Access, PATH
  • Colette Cote, PhD, US General Manager and Chief Scientific and Portfolio Officer, PathoQuest
  • Arifa Khan, PhD, Head, Molecular Retrovirology Unit, Division of Viral Products, Office of Vaccines Research and Review in the Center for Biologics Evaluation and Research, US Food and Drug Administration
  • Bradley Hasson, MBA, Director of Lab Operations for Next Generation Sequencing, Millipore Sigma
  • Leyla Diaz, PhD, Technical Consultant, Scientific and Regulatory Consultancy, Millipore Sigma
  • Konstantin Chumakov, PhD, Adjunct Professor, George Washington University and University of Maryland
  • Javier Martin, PhD, Principal Scientist, Medicines and Healthcare products Regulatory Agency (UK)
  • Manasi Majumdar, PhD, Principal Scientist, Medicines and Healthcare products Regulatory Agency (UK)
  • Yola Eka Erwinda, MS, Senior Laboratory Officer, Biological Products Laboratory Division, Indonesian Food and Drug Control
  • Devendra Barthwal, MS, Assistant Technical Officer, Central Drugs Laboratory, Kasauli, India, and certified WHO Inspector

Please note: The slides and recording from Day 2 presentation 2.3 are temporarily unavailable. They will be added to this site at a future date.

Corporate author(s): PATH, PathoQuest, Millipore Sigma, US Food and Drug Administration, India Central Drugs Laboratory, Indonesian Food and Drug Control, UK Medicines & Healthcare products Regulatory Agency

Publication date: November 2025

Available materials

  1. English

    1. Day 1, presentation 1.2: NGS process overview 3.4 MB PDF
    2. Day 1, presentation 1.3: Current status of NGS sequencing for adventitious virus testing and regulatory expectations 2.4 MB PDF
    3. Day 1, presentation 1.4: Validation of an NGS sequencing method for adventitious virus detection in biologically derived products 1.1 MB PDF
    4. Day 2, presentation 2.2: NGS for molecular consistency monitoring of biopharmaceuticals 6.5 MB PDF

  2. English

    1. Webinar recording: Day 1
    2. Webinar recording: Day 2