Development of a candidate reference material for adventitious virus detection in vaccine and biologicals manufacturing by deep sequencing.

Détails

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Etat: Public
Version: Final published version
ID Serval
serval:BIB_000A07822074
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Titre
Development of a candidate reference material for adventitious virus detection in vaccine and biologicals manufacturing by deep sequencing.
Périodique
Vaccine
Auteur(s)
Mee E.T., Preston M.D., Minor P.D., Schepelmann S.
Collaborateur(s)
CS533 Study Participants
Contributeur(s)
Huang X., Nguyen J., Wall D., Hargrove S., Fu T., Xu G., Li L., Cote C., Delwart E., Li L., Hewlett I., Simonyan V., Ragupathy V., Alin V.K., Mermod N., Hill C., Ottenwälder B., Richter D.C., Tehrani A., Jacqueline W.L., Cassart J.P., Letellier C., Vandeputte O., Ruelle J.L., Deyati A., La Neve F., Modena C., Mee E., Schepelmann S., Preston M., Minor P., Eloit M., Muth E., Lamamy A., Jagorel F., Cheval J., Anscombe C., Misra R., Wooldridge D., Gharbia S., Rose G., Ng S.H., Charlebois R.L., Gisonni-Lex L., Mallet L., Dorange F., Chiu C., Naccache S., Kellam P., van der Hoek L., Cotten M., Mitchell C., Baier B.S., Sun W., Malicki H.D.
ISSN
1873-2518 (Electronic)
ISSN-L
0264-410X
Statut éditorial
Publié
Date de publication
2016
Volume
34
Numéro
17
Pages
2035-2043
Langue
anglais
Résumé
Unbiased deep sequencing offers the potential for improved adventitious virus screening in vaccines and biotherapeutics. Successful implementation of such assays will require appropriate control materials to confirm assay performance and sensitivity.
A common reference material containing 25 target viruses was produced and 16 laboratories were invited to process it using their preferred adventitious virus detection assay.
Fifteen laboratories returned results, obtained using a wide range of wet-lab and informatics methods. Six of 25 target viruses were detected by all laboratories, with the remaining viruses detected by 4-14 laboratories. Six non-target viruses were detected by three or more laboratories.
The study demonstrated that a wide range of methods are currently used for adventitious virus detection screening in biological products by deep sequencing and that they can yield significantly different results. This underscores the need for common reference materials to ensure satisfactory assay performance and enable comparisons between laboratories.

Mots-clé
Biological Products/standards, Drug Contamination/prevention & control, High-Throughput Nucleotide Sequencing, Laboratories, Reference Standards, Vaccines/standards, Viruses/isolation & purification
Pubmed
Web of science
Open Access
Oui
Création de la notice
31/01/2017 11:13
Dernière modification de la notice
20/08/2019 12:21
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