Development of a candidate reference material for adventitious virus detection in vaccine and biologicals manufacturing by deep sequencing.
Details
State: Public
Version: Final published version
Serval ID
serval:BIB_000A07822074
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Development of a candidate reference material for adventitious virus detection in vaccine and biologicals manufacturing by deep sequencing.
Journal
Vaccine
Working group(s)
CS533 Study Participants
Contributor(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
Publication state
Published
Issued date
2016
Volume
34
Number
17
Pages
2035-2043
Language
english
Abstract
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.
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.
Keywords
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
Yes
Create date
31/01/2017 11:13
Last modification date
20/08/2019 12:21
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