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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
biochemistry, genetics and molecular biology
Development of a candidate reference material for adventitious virus detection in vaccine and biologicals manufacturing by deep sequencing
Vaccine, Volume 34, No. 17, Year 2016
Notification
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Description
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. © 2015 The Authors.
Authors & Co-Authors
Mee, Edward T.
United Kingdom, London
Medicines and Healthcare Products Regulatory Agency
Minor, Phillip D.
United Kingdom, London
Medicines and Healthcare Products Regulatory Agency
Delwart, E. L.
United States, San Francisco
Vitalant Research Institute
United States, San Francisco
University of California, San Francisco
Li, Linlin
United States, San Francisco
Vitalant Research Institute
United States, San Francisco
University of California, San Francisco
Hewlett, Indira K.
United States, Silver Spring
Food and Drug Administration
Ragupathy, Viswanath
United States, Silver Spring
Food and Drug Administration
Tehrani, Arman
Luxembourg, Luxembourg
Eurofins Gsc Lux
Letellier, Carine
Belgium, Wavre
Glaxosmithkline Pharmaceuticals Sa/nv
Preston, Mark D.
United Kingdom, Hertfordshire
National Institute for Biological Standards and Control
Éloit, Marc E.
Unknown Affiliation
Anscombe, Catherine
United Kingdom, London
Public Health England
Gharbia, Saheer E.
United Kingdom, London
Public Health England
Rose, Graham
United Kingdom, London
Public Health England
Chiu, Charles Y.
United States, San Francisco
University of California, San Francisco
Naccache, Samia N.
United States, San Francisco
University of California, San Francisco
Kellam, P.
United Kingdom, Hinxton
Wellcome Sanger Institute
van der Hoek, Lia M.
United Kingdom, Hinxton
Wellcome Sanger Institute
Cotten, Matt
United Kingdom, Hinxton
Wellcome Sanger Institute
Statistics
Citations: 30
Authors: 18
Affiliations: 12
Identifiers
Doi:
10.1016/j.vaccine.2015.12.020
ISSN:
0264410X