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.