On 27-28 September, representatives of the EDQM participated in the 3rd Conference on Next Generation Sequencing for Adventitious Virus Detection in Biologics for Humans and Animals organised by the International Alliance for Biological Standardization (IABS) in Rockville, Maryland, U.S.A.
At the event, Laurent Mallet, Head of the Biological Standardisation, OMCL Network and Healthcare Department and Gwenael Cirefice, Scientific Programme Officer, European Pharmacopoeia Department, gave an overview of what has already been achieved by the EDQM/the European Pharmacopoeia (Ph. Eur.) in Next Generation Sequencing (NGS) and also outlined perspectives for the future in this rapidly developing field. In particular, their presentation focused on the ongoing drafting, by an international working group of experts, of a new Ph. Eur. general chapter (2.6.41) that will describe NGS technology and include guidelines for validation of the method.
The meeting, co-chaired by the US FDA (Arifa Khan) and the EDQM (Laurent Mallet), brought together representatives from industry, academia, contract research organisations and international regulatory bodies. The focus was on reaching a scientific consensus on recommendations for the use of NGS for the detection of adventitious viruses.
“This 3rd IABS NGS conference was a great opportunity to share the impressive progress made in the field since the 2nd IABS NGS Conference in Ghent in November 2019, in particular the first validation data that were published in 2020 and, based on the first submissions received, to clarify regulatory expectations in both the USA and Europe” said Laurent Mallet.
Did You know?
Next Generation Sequencing (NGS) is an innovative technology that can be used to detect extraneous/adventitious agents that may contaminate biological products.
NGS was first included in the European Pharmacopoeia in 2017, in two general chapters (5.2.3 and 2.6.16) on vaccines for human use. These chapters are also applicable for gene therapy vectors.
The new general chapter (2.6.41) will help promote the use of this innovative technology which is set to be included in the ICHQ5A revised guidelines.
- 3rd Conference on Next Generation Sequencing for Adventitious Virus Detection in Biologics for Humans and Animals
- Biological Standardisation Programme (BSP)
- OMCL Network
- European Pharmacopoeia (Ph. Eur.)