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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:
- Currently used reference materials and standards
- Types of standards that are appropriate for various stages of the sequencing process
- Limitations of current standards
- Additional standards needed
- 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
|
09:00 |
Welcome Remarks Michael Tarlov, NIST |
|
09:10 |
Current Practices for Regulatory Applications Arifa Khan, FDA |
|
09:40 |
Overview of NIST Viral Standards Megan Cleveland, NIST |
|
10:10-10:30 |
Coffee break |
|
10:30 |
dPCR as a reference measurement procedure for viral detection and quantification Jim Huggett, UK National Measurement Laboratory |
|
11:00 |
Standardization of Next Generation Sequencing Methods for the Quality Control of Live-attenuated Vaccines Javier Martin, National Institute for Biological Standards and Control (NIBSC) |
|
11:30 |
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 |
Lunch |
Session 2 – Current Viral Reference Materials
|
2:00 |
Characterization of Reference Viral Stocks for NGS Standardization Pei-Ju Chin, FDA |
|
2:30 |
Exploring the Human Virome – The importance of Standards Heather Couch, ATCC |
|
2:45 -3:15 |
Coffee Break |
|
3:15 |
Sensitivity of NGS Based Viral Detection Methods using Viral Stocks Characterized for Genome Copy Number Mike Brewer, Thermo Fisher Scientific |
|
3:30 |
NGS Internal Controls for Adventitious Agent Testing to Ensure Sensitivity for All Targets in Every Sample Tom Morrison, Accugenomics |
|
3:45 |
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
|
9:00 |
Welcome back |
|
9:05 |
Identification of Highly Divergent Viral Sequences Eric Delwart, UCSF |
|
9:35 |
Potential Controls for an NGS Adventitious Virus Detection Assay Siemon Ng, Sanofi |
|
10:05 – 10:30 |
Coffee break
|
|
10:30 |
Microbiome and Metagenomic Standards Scott Jackson, NIST |
|
11:00 |
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
|
12:00-1:00 |
Topic Discussion – I Natural standards – Live Viral and extracted nucleic acids Co-leader: Arifa Khan Co-leader: Siemon Ng |
|
1-2 |
Lunch |
|
2-3 |
Topic Discussion – II Synthetic standards – a nucleic acids b engineered particles Co-leader: Viswanath Ragupathy Co-leader: Eric Delwart |
|
3-3:55 |
Summary Discussion: Priorities, implementation, resources, collaboration Leader: Megan Cleveland |
|
3:55-4:00 |
Closing Remarks, Arifa Khan |
Doubletree Hilton
620 Perry Parkway, Gaithersburg, Maryland 20877
Book by September 22nd to reserve your special rate starting at $119/night. A complimentary shuttle will be provided to and from NIST.
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