The IABS NGS webinar will give an introduction to Next Generation Sequencing ( NGS) technologies and their applications in the viral safety testing package of biological products. It will particularly cover a review of the sources of introducing adventitious viral agent contamination in the biomanufacturing process, reports of cases of contamination with adventitious viral agents, considerations for using NGS as an alternative method for the current adventitious virus detection assays, and an overview of the different steps in the NGS workflow.
The talks and discussions focus on enhancing viral safety of biologics. The webinar will also provide an overview of the Advanced Virus Detection Technologies Working group (AVDTWG) activities and an update of the regulatory landscape from various regions.
The webinar is addressed to all manufacturers and regulators who want to learn about NGS applications for adventitious viral agent detection in biological products following its recent introduction in the ICHQ5A (R2) guideline and the publication for comment of the new EDQM/Ph. Eur general chapter 2.6.41 “High-Throughput Sequencing for the detection of viral extraneous agents.
Scientific Committee
Arifa S. Khan - Co-chair, FDA-CBER (FDA), U.S.A.
Laurent Mallet - Co-chair, EDQM, France
Pieter Neels - IABS Chair, Belgium
Johannes Blümel - PEI, Germany
Noémie Deneyer - GSK, Belgium
Sigrid De Keersmaecker - Sciensano, Belgium
Blandine De Saint-Vis - Boehringer- Ingelheim, France
Ivana Knezevic - WHO, Switzerland
Carine Logvinoff - Sanofi, France
Marie Murphy - Eli Lilly, Ireland
Siemon Ng - Notch Therapeutics, Canada
Yoji Sato - National Institute of Health Sciences, Japan
