Historical evaluation of the in vivo adventitious virus test and its potential for replacement with next generation sequencing (NGS)-Reference-Cited by-同舟云学术

Historical evaluation of the in vivo adventitious virus test and its potential for replacement with next generation sequencing (NGS)

Published:2023-02 Issue: Volume:81 Page:101661
ISSN:1045-1056
Container-title:Biologicals
language:en
Short-container-title:Biologicals

Author:

Barone Paul W.^ORCID,Keumurian Flora J.,Neufeld Caleb,Koenigsberg Andrea,Kiss Robert,Leung James^ORCID,Wiebe Michael^ORCID,Ait-Belkacem Rima,Azimpour Tabrizi Chakameh^ORCID,Barbirato Cristina,Beurdeley Pascale,Brussel Audrey,Cassart Jean-Pol,Cote Colette^ORCID,Deneyer Noémie,Dheenadhayalan Veera,Diaz Leyla,Geiselhoeringer Angela,Gilleece Maria M.,Goldmann Jakob,Hickman Danielle^ORCID,Holden Angela^ORCID,Keiner Björn,Kopp Martina,Kreil Thomas R.,Lambert Christophe,Logvinoff Carine,Michaels Brandye,Modrof Jens,Mullan Brian,Mullberg Jürgen,Murphy Marie,O'Donnell Sean,Peña José^ORCID,Ruffing Michael,Ruppach Horst,Salehi Nasrin,Shaid Shahjahan,Silva Lindsey,Snyder Richard,Spedito-Jovial Mélancolie,Vandeputte Olivier,Westrek Bernice,Yang Bin,Yang Ping^ORCID,Springs Stacy L.

Publisher

Elsevier BV

Subject

Pharmacology,General Immunology and Microbiology,Applied Microbiology and Biotechnology,General Medicine,Bioengineering,Biotechnology

Reference42 articles.

1. Viral contamination in biologic manufacture and implications for emerging therapies;Barone;Nat Biotechnol,2020

2. Viral nucleic acids in live-attenuated vaccines: detection of minority variants and an adventitious virus;Victoria;J Virol,2010

3. Q5A viral safety evaluation of biotechnology products derived from cell lines of human or animal origin,1997

4. Systematic evaluation of in vitro and in vivo adventitious virus assays for the detection of viral contamination of cell banks and biological products;Gombold;Vaccine,2014

5. Characterization and qualification of cell substrates and other biological materials used in the production of viral vaccines for infectious disease indications,2010

Cited by 5 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Evaluation of next-generation sequencing performance for in vitro detection of viruses in biological products;Biologicals;2024-02

2. Evaluation of a viral transcriptome Next Generation Sequencing assay as an alternative to animal assays for viral safety testing of cell substrates;Vaccine;2023-08

3. Effects of the COVID-19 pandemic: new approaches for accelerated delivery of gene to first-in-human CMC data for recombinant proteins;mAbs;2023-06-06

4. Rational arguments for regulatory acceptance of consistency testing: benefits of non-animal testing over in vivo release testing of vaccines;Expert Review of Vaccines;2023-04-19

5. Next-Generation Sequencing: A Promising Tool for Vaccines and Other Biological Products;Vaccines;2023-02-23