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

CS533 Study Participants

Research output: Contribution to journalArticlepeer-review

28 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 languageEnglish
Pages (from-to)2035-2043
Number of pages9
JournalVaccine
Volume34
Issue number17
DOIs
Publication statusPublished - 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

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