Report of the 2019 NIST-FDA Workshop on Standards for Next Generation Sequencing Detection of Viral Adventitious Agents in Biologics and Biomanufacturing

Published

February 22, 2021

Author(s)

Megan Cleveland, Bharathi Anekella, Mike Brewer, Pei-Ju Chin, Heather Couch, Eric Delwart, Jim Huggett, Scott Jackson, Javier Martin, Serge Monpoeho, Tom Morrison, Siemon Ng, David Ussery, Arifa Khan

Abstract

Adventitious virus testing assures product safety by demonstrating the absence of viruses that may have been unintentionally introduced during the manufacturing process. The capabilities of next-generation or high-throughput sequencing (NGS/HTS) for broad virus detection in biologics have been demonstrated by the detection of known and novel viruses that were previously missed using the recommended routine assays for adventitious agent testing. This meeting was co- organized by the National Institute of Standards and Technology (NIST) and the U.S. Food and Drug Administration (FDA) on September 18-19, 2019 in Gaithersburg, Maryland, USA, to facilitate standardization of NGS technologies for applications of adventitious virus testing in biologics. The goal was to assess the currently used standards for virus detection by NGS and their public availability, and to identify additional needs for different types of reference materials and standards (natural and synthetic). The meeting focused on the NGS processes from sample preparation through sequencing but did not thoroughly cover bioinformatics, since this should be the topic of a separate meeting.

Citation

Biologicals

Pub Type

Journals

Download Paper

https://doi.org/10.1016/j.biologicals.2020.02.003

Local Download

Keywords

Adventitious, viruses, Biologics, Next generation sequencing, High throughput sequencing, Bioinformatics, Standards, Standardization

Citation

Cleveland, M. , Anekella, B. , Brewer, M. , Chin, P. , Couch, H. , Delwart, E. , Huggett, J. , Jackson, S. , Martin, J. , Monpoeho, S. , Morrison, T. , Ng, S. , Ussery, D. and Khan, A. (2021), Report of the 2019 NIST-FDA Workshop on Standards for Next Generation Sequencing Detection of Viral Adventitious Agents in Biologics and Biomanufacturing, Biologicals, [online], https://doi.org/10.1016/j.biologicals.2020.02.003, https://tsapps.nist.gov/publication/get_pdf.cfm?pub_id=929625 (Accessed October 10, 2025)