DCVMN Webinar : Next Generation Sequencing (IABS)
Speakers: Pieter Neels
Sebastiaan Theuns
Laurent Mallet
Gwenaël Ciréfice
Arifa Khan
Ravneet Bhuller
Abstract
IABS is a non-for-profit organisation that brings together academia, authority regulators and industry to discuss challenging projects.
Next Generation Sequencing (NGS) is such a project. It is a new technique that might replace a number of time consuming and costly viral testing, and time consuming, to show the absence of adventitious agents.
In Washington, September 28-29, the 3rd IABS NGS meeting will take place to discuss the implementation of these new techniques in detecting adventitious agents in the production and development of new and old vaccines.
However, not everyone is familiar with NGS and therefore IABS together with DCVMN decided to organise a webinar to give an introduction on NGS, in fact to initiate people not aware of these new techniques in order to understand the topics being discussed at the September meeting to implement these money and time saving techniques.
This is an invitation for people working in the field of vaccine production and development that are not aware of these new techniques and want to learn more about it to improve the production and development of their vaccines.
This is a collaboration between IABS and DCMN to improve knowledge of new techniques.
Proposed Agenda
Proposed Agenda
13:00-13:05 Welcome Pieter Neels
13:05-13:25 Introduction to NGS Sebastiaan Theuns
Burning questions
13:30-13:50 Regulatory aspects at EDQM Laurent Mallet
Burning questions
12:55-14:15 Reference Materials for NGS Arifa Khan
Burning questions
14:20-14:40 NGS at WHO/ECBS/NIBSC TBC
14:40-15:00 Questions all
Next Generation Sequencing (NGS) is a new technology that could overcome some of the limitations of the current viral testing methods for demonstrating the absence of adventitious agents in biologics. This report follows up on the webinar organized by the IABS – International Alliance for Biological Standardization and the Developing Countries Vaccine Manufacturers Network (DCVMN), held on July 2022, as an introduction to the technical and bioinformatics concepts of NGS and to some of the strengths and limitations of using the technology for those working in vaccine production or development. The application of NGS to supplement or replace current in vivo and in vitro assays in adventitious virus testing during vaccine production is promising; however, assay performance (sensitivity, specificity, and reproducibility) needs to be demonstrated, which may include laboratory and bioinformatics work. Efforts from regulatory authorities, industry, and researchers are ongoing to facilitate validation and establishment of NGS as a new method for virus detection.
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