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

CS533 Study Participants

doi:10.1016/j.vaccine.2015.12.020

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

CS533 Study Participants

Gastrointestinal Infections

Research output: Contribution to journal › Article › peer-review

33 Citations (Scopus)

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.

Original language	English
Pages (from-to)	2035-2043
Number of pages	9
Journal	Vaccine
Volume	34
Issue number	17
DOIs	https://doi.org/10.1016/j.vaccine.2015.12.020
Publication status	Published - 12 Apr 2016

Bibliographical note

Funding Information:
We are grateful to the participants of the study for contributing time and resources. We would like to thank Dr. Rob Anderson, Dr. Sophie Collot-Teixeira and Dr. Kathryn Doris at NIBSC for provision of reagent 11/242-001 and advice on production and characterisation. We are grateful to the NIBSC Sales and Dispatch Team, in particular Mark Harris and Paul Bolton for co-ordination of reagent shipments and thank members of the FDA/PDA Advanced Virus Detection Technologies Interest Group for helpful discussions and feedback. This report is independent research which, in part, was commissioned and funded by the Department of Health Policy Research Programme (NIBSC Regulatory Science Research Unit, 044/0069). Funding reported by participants: NIH grant number R01-HL-105770 to Eric Delwart. The views expressed in this publication are those of the author(s) and not necessarily those of the Department of Health. Conflict of interest : The authors declare no conflicts of interest related to this study. An edited version of this report has been submitted to the World Health Organisation for consideration by the 2015 meeting of the Expert Committee on Biological Standardisation.

Funding Information:
We are grateful to the participants of the study for contributing time and resources. We would like to thank Dr. Rob Anderson, Dr. Sophie Collot-Teixeira and Dr. Kathryn Doris at NIBSC for provision of reagent 11/242-001 and advice on production and characterisation. We are grateful to the NIBSC Sales and Dispatch Team, in particular Mark Harris and Paul Bolton for co-ordination of reagent shipments and thank members of the FDA/PDA Advanced Virus Detection Technologies Interest Group for helpful discussions and feedback. This report is independent research which, in part, was commissioned and funded by the Department of Health Policy Research Programme (NIBSC Regulatory Science Research Unit, 044/0069). Funding reported by participants: NIH grant number R01-HL-105770 to Eric Delwart. The views expressed in this publication are those of the author(s) and not necessarily those of the Department of Health.

Publisher Copyright:
© 2015 The Authors.

Copyright:
Copyright 2019 Elsevier B.V., All rights reserved.

Keywords

Adventitious virus
Collaborative study
Deep sequencing
Reference material
Vaccine

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1016/j.vaccine.2015.12.020

Cite this

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title = "Development of a candidate reference material for adventitious virus detection in vaccine and biologicals manufacturing by deep sequencing",

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.",

keywords = "Adventitious virus, Collaborative study, Deep sequencing, Reference material, Vaccine",

author = "{CS533 Study Participants} and Mee, {Edward T.} and Preston, {Mark D.} and Minor, {Philip D.} and Silke Schepelmann and Xuening Huang and Jenny Nguyen and David Wall and Stacey Hargrove and Thomas Fu and George Xu and Li Li and Colette Cote and Eric Delwart and Linlin Li and Indira Hewlett and Vahan Simonyan and Viswanath Ragupathy and Alin Voskanian-Kordi and Nicolas Mermod and Christiane Hill and Birgit Ottenwalder and Richter, {Daniel C.} and Arman Tehrani and Jacqueline Weber-Lehmann and Cassart, {Jean Pol} and Carine Letellier and Olivier Vandeputte and Ruelle, {Jean Louis} and {La Neve}, Fabio and Avisek Deyati and Chiara Modena and Edward Mee and Mark Preston and Philip Minor and Marc Eloit and Erika Muth and Arnaud Lamamy and Florence Jagorel and Justine Cheval and Catherine Anscombe and Raju Misra and David Wooldridge and Saheer Gharbia and Graham Rose and Ng, {Siemon H.S.} and Charlebois, {Robert L.} and Lucy Gisonni-Lex and Laurent Mallet and Fabien Dorange and Charles Chiu",

note = "Funding Information: We are grateful to the participants of the study for contributing time and resources. We would like to thank Dr. Rob Anderson, Dr. Sophie Collot-Teixeira and Dr. Kathryn Doris at NIBSC for provision of reagent 11/242-001 and advice on production and characterisation. We are grateful to the NIBSC Sales and Dispatch Team, in particular Mark Harris and Paul Bolton for co-ordination of reagent shipments and thank members of the FDA/PDA Advanced Virus Detection Technologies Interest Group for helpful discussions and feedback. This report is independent research which, in part, was commissioned and funded by the Department of Health Policy Research Programme (NIBSC Regulatory Science Research Unit, 044/0069). Funding reported by participants: NIH grant number R01-HL-105770 to Eric Delwart. The views expressed in this publication are those of the author(s) and not necessarily those of the Department of Health. Conflict of interest : The authors declare no conflicts of interest related to this study. An edited version of this report has been submitted to the World Health Organisation for consideration by the 2015 meeting of the Expert Committee on Biological Standardisation. Funding Information: We are grateful to the participants of the study for contributing time and resources. We would like to thank Dr. Rob Anderson, Dr. Sophie Collot-Teixeira and Dr. Kathryn Doris at NIBSC for provision of reagent 11/242-001 and advice on production and characterisation. We are grateful to the NIBSC Sales and Dispatch Team, in particular Mark Harris and Paul Bolton for co-ordination of reagent shipments and thank members of the FDA/PDA Advanced Virus Detection Technologies Interest Group for helpful discussions and feedback. This report is independent research which, in part, was commissioned and funded by the Department of Health Policy Research Programme (NIBSC Regulatory Science Research Unit, 044/0069). Funding reported by participants: NIH grant number R01-HL-105770 to Eric Delwart. The views expressed in this publication are those of the author(s) and not necessarily those of the Department of Health. Publisher Copyright: {\textcopyright} 2015 The Authors. Copyright: Copyright 2019 Elsevier B.V., All rights reserved.",

year = "2016",

month = apr,

day = "12",

doi = "10.1016/j.vaccine.2015.12.020",

language = "English",

volume = "34",

pages = "2035--2043",

journal = "Vaccine",

issn = "0264-410X",

publisher = "Elsevier Ltd.",

number = "17",

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TY - JOUR

T1 - Development of a candidate reference material for adventitious virus detection in vaccine and biologicals manufacturing by deep sequencing

AU - CS533 Study Participants

AU - Mee, Edward T.

AU - Preston, Mark D.

AU - Minor, Philip D.

AU - Schepelmann, Silke

AU - Huang, Xuening

AU - Nguyen, Jenny

AU - Wall, David

AU - Hargrove, Stacey

AU - Fu, Thomas

AU - Xu, George

AU - Li, Li

AU - Cote, Colette

AU - Delwart, Eric

AU - Li, Linlin

AU - Hewlett, Indira

AU - Simonyan, Vahan

AU - Ragupathy, Viswanath

AU - Voskanian-Kordi, Alin

AU - Mermod, Nicolas

AU - Hill, Christiane

AU - Ottenwalder, Birgit

AU - Richter, Daniel C.

AU - Tehrani, Arman

AU - Weber-Lehmann, Jacqueline

AU - Cassart, Jean Pol

AU - Letellier, Carine

AU - Vandeputte, Olivier

AU - Ruelle, Jean Louis

AU - La Neve, Fabio

AU - Deyati, Avisek

AU - Modena, Chiara

AU - Mee, Edward

AU - Preston, Mark

AU - Minor, Philip

AU - Eloit, Marc

AU - Muth, Erika

AU - Lamamy, Arnaud

AU - Jagorel, Florence

AU - Cheval, Justine

AU - Anscombe, Catherine

AU - Misra, Raju

AU - Wooldridge, David

AU - Gharbia, Saheer

AU - Rose, Graham

AU - Ng, Siemon H.S.

AU - Charlebois, Robert L.

AU - Gisonni-Lex, Lucy

AU - Mallet, Laurent

AU - Dorange, Fabien

AU - Chiu, Charles

N1 - Funding Information: We are grateful to the participants of the study for contributing time and resources. We would like to thank Dr. Rob Anderson, Dr. Sophie Collot-Teixeira and Dr. Kathryn Doris at NIBSC for provision of reagent 11/242-001 and advice on production and characterisation. We are grateful to the NIBSC Sales and Dispatch Team, in particular Mark Harris and Paul Bolton for co-ordination of reagent shipments and thank members of the FDA/PDA Advanced Virus Detection Technologies Interest Group for helpful discussions and feedback. This report is independent research which, in part, was commissioned and funded by the Department of Health Policy Research Programme (NIBSC Regulatory Science Research Unit, 044/0069). Funding reported by participants: NIH grant number R01-HL-105770 to Eric Delwart. The views expressed in this publication are those of the author(s) and not necessarily those of the Department of Health. Conflict of interest : The authors declare no conflicts of interest related to this study. An edited version of this report has been submitted to the World Health Organisation for consideration by the 2015 meeting of the Expert Committee on Biological Standardisation. Funding Information: We are grateful to the participants of the study for contributing time and resources. We would like to thank Dr. Rob Anderson, Dr. Sophie Collot-Teixeira and Dr. Kathryn Doris at NIBSC for provision of reagent 11/242-001 and advice on production and characterisation. We are grateful to the NIBSC Sales and Dispatch Team, in particular Mark Harris and Paul Bolton for co-ordination of reagent shipments and thank members of the FDA/PDA Advanced Virus Detection Technologies Interest Group for helpful discussions and feedback. This report is independent research which, in part, was commissioned and funded by the Department of Health Policy Research Programme (NIBSC Regulatory Science Research Unit, 044/0069). Funding reported by participants: NIH grant number R01-HL-105770 to Eric Delwart. The views expressed in this publication are those of the author(s) and not necessarily those of the Department of Health. Publisher Copyright: © 2015 The Authors. Copyright: Copyright 2019 Elsevier B.V., All rights reserved.

PY - 2016/4/12

Y1 - 2016/4/12

N2 - 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.

AB - 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.

KW - Adventitious virus

KW - Collaborative study

KW - Deep sequencing

KW - Reference material

KW - Vaccine

UR - http://www.scopus.com/inward/record.url?scp=84960968448&partnerID=8YFLogxK

U2 - 10.1016/j.vaccine.2015.12.020

DO - 10.1016/j.vaccine.2015.12.020

M3 - Article

C2 - 26709640

AN - SCOPUS:84960968448

SN - 0264-410X

VL - 34

SP - 2035

EP - 2043

JO - Vaccine

JF - Vaccine

IS - 17

ER -

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

Abstract

Bibliographical note

Keywords

UN SDGs

Access to Document

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Cite this