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Workshop on Standards for NGS Detection of Viral Adventitious Agents in Biologics and Biomanufacturing

Slides from each speaker's talk are available in this .zip file

This NIST workshop, co-organized with FDA,  will focus on the development of different types of standards for supporting standardization of Next Generation Sequencing (NGS) for detection of adventitious viruses in biologics (including viral vaccines, gene therapies, and biotherapeutics). Adventitious viruses may be unintentionally introduced during biomanufacturing via cell banks, viral seeds, raw materials, or the environment (such as equipment and handling). Currently, extensive adventitious virus testing is recommended; however, some of the tests are time-consuming and, in addition, may not detect all potential adventitious viruses. NGS testing for adventitious viruses can offer faster turnaround time and broad detection of adventitious agents, including known and novel viruses.

The workshop will cover all aspects of the sequencing process from upstream sample processing, extraction, cDNA synthesis, library preparation, and sequencing.  Bioinformatics will not be covered.

The following topics will be discussed:

  1. Currently used reference materials and standards
  2. Types of standards that are appropriate for various stages of the sequencing process
  3. Limitations of current standards
  4. Additional standards needed
  5. Characterization of standards

The workshop will include presentations and panel discussions from international regulatory authorities and other government agencies, academics, industry, and CROs. The availability of different standards will facilitate NGS applications for virus detection in biologics and biomanufacturing.


Day 1 - Wednesday, September 18, 2019

Session 1 – Perspectives on Standardization


Welcome Remarks

Michael Tarlov, NIST


Current Practices for Regulatory Applications

Arifa Khan, FDA


Overview of NIST Viral Standards

Megan Cleveland, NIST


Coffee break


dPCR as a reference measurement procedure for viral detection and quantification

Jim Huggett, UK National Measurement Laboratory


Standardization of Next Generation Sequencing Methods for the Quality Control of Live-attenuated Vaccines

Javier Martin, National Institute for Biological Standards and Control (NIBSC)


Building Standardized Dendograms for Viruses

David Ussery, University of Arkansas for Medical Sciences

12:00 – 12:30

Q&A and Discussion

12:30 – 2:00


Session 2 – Current Viral Reference Materials


Characterization of Reference Viral Stocks for NGS Standardization

Pei-Ju Chin, FDA


Exploring the Human Virome – The importance of Standards

Heather Couch, ATCC

2:45 -3:15

Coffee Break


Sensitivity of NGS Based Viral Detection Methods using Viral Stocks Characterized for Genome Copy Number

Mike Brewer, Thermo Fisher Scientific


NGS Internal Controls for Adventitious Agent Testing to Ensure Sensitivity for All Targets in Every Sample

Tom Morrison, Accugenomics


AccuPlex™ Recombinant Virus Technology – A tool to generate reference material for pathogenic virus

Bharathi Anekella, LGC-SeraCare

4:00– 5:00

Q&A and Discussion

Day 2 - Thursday, September 19, 2019

Session 3 – Applications of standards for adventitious virus testing for biologics


Welcome back


Identification of Highly Divergent Viral Sequences

Eric Delwart, UCSF


Potential Controls for an NGS Adventitious Virus Detection Assay

Siemon Ng, Sanofi

10:05 – 10:30

Coffee break



Microbiome and Metagenomic Standards

Scott Jackson, NIST


Background NGS data for Sample Matrix and Reference Control Standards Using Nanopore Sequencing

 Serge Monpoeho, Regeneron

11:30 – 12:00

Q&A - discussion



Session 4 – Discussion on standards and moving forward


Topic Discussion – I Natural standards – Live Viral and extracted nucleic acids

Co-leader: Arifa Khan

Co-leader: Siemon Ng




Topic Discussion – II Synthetic standards – a nucleic acids b engineered particles

Co-leader: Viswanath Ragupathy

Co-leader: Eric Delwart


Summary Discussion: Priorities, implementation, resources, collaboration

Leader: Megan Cleveland


Closing Remarks, Arifa Khan



Doubletree Hilton 
620 Perry Parkway, Gaithersburg, Maryland 20877


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Book by September 22nd to reserve your special rate starting at $119/night. A complimentary shuttle will be provided to and from NIST.


NON U.S. CITIZENS PLEASE NOTE: All foreign national visitors who do not have permanent resident status and who wish to register for the above meeting must supply additional information. Failure to provide this information prior to arrival will result, at a minimum, in significant delays in entering the facility. Authority to gather this information is derived from United States Department of Commerce Department Administrative Order (DAO) number 207-12.

*New Visitor Access Requirement: Effective July 21, 2014, Under the REAL ID Act of 2005, agencies, including NIST, can only accept a state-issued driver’s license or identification card for access to federal facilities if issued by states that are REAL ID compliant or have an extension. As of Monday, January 30, 2017, Federal agencies will be prohibited from accepting driver’s licenses and identification cards from the following states for accessing federal facilities: Maine, Minnesota, Missouri, Montana and Washington. For further details, please visit our Campus Access and Security page.

Acceptable Photo Identification:

For Non-US Citizens: Valid passport for photo identification

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Created June 7, 2019, Updated October 15, 2019