Development of a candidate reference material for adventitious virus detection in vaccine and biologicals manufacturing by deep sequencing
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Published version
Author(s)
Mee, Edward T
Preston, Mark D
Participant, CSS Study
Minor, Philip D
Schepelmann, Silke
Type
Journal Article
Abstract
Background
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.
Methods
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.
Results
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.
Conclusion
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.
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.
Methods
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.
Results
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.
Conclusion
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.
Date Issued
2016-04-12
Date Acceptance
2015-12-05
Citation
Vaccine, 2016, 34 (17), pp.2035-2043
ISSN
0264-410X
Publisher
Elsevier
Start Page
2035
End Page
2043
Journal / Book Title
Vaccine
Volume
34
Issue
17
Copyright Statement
© 2015 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
Identifier
http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000374083400010&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=1ba7043ffcc86c417c072aa74d649202
Subjects
Science & Technology
Life Sciences & Biomedicine
Immunology
Medicine, Research & Experimental
Research & Experimental Medicine
Adventitious virus
Vaccine
Deep sequencing
Reference material
Collaborative study
PORCINE CIRCOVIRUS
RIBONUCLEIC ACID
CONTAMINATION
SAMPLES
CELLS
IDENTIFICATION
INFECTIVITY
POLIOVIRUS
DISCOVERY
PATHOGENS
Publication Status
Published
Date Publish Online
2015-12-19