Development of a candidate reference material for adventitious virus detection in vaccine and biologicals manufacturing by deep sequencing
| Autor: | Brian S. Baier, Christine Mitchell, Fabien Dorange, Indira Hewlett, Heather D. Malicki, David Wall, Philip D. Minor, Catherine Anscombe, Wenping Sun, Erika Muth, Chiara Modena, Birgit Ottenwälder, Eric Delwart, Jean-Louis Ruelle, Christiane Hill, Jean-Pol Cassart, Saheer E. Gharbia, Stacey Hargrove, Florence Jagorel, Viswanath Ragupathy, Lucy Gisonni-Lex, Edward Mee, Linlin Li, Voskanian-Kordi Alin, Samia N. Naccache, Siemon H. S. Ng, Laurent Mallet, Edward T. Mee, Daniel C. Richter, Fabio La Neve, Jenny Nguyen, Arman Tehrani, Mark D. Preston, Matthew Cotten, David J. Wooldridge, Olivier Vandeputte, Xuening Huang, Justine Cheval, Lia van der Hoek, Graham Rose, Raju Misra, Marc Eloit, Vahan Simonyan, Avisek Deyati, Silke Schepelmann, Paul Kellam, Nicolas Mermod, Mark Preston, George Xu, Charles Y. Chiu, Thomas Fu, Li Li, Carine Letellier, Robert L. Charlebois, Colette Cote, Weber-Lehmann Jacqueline, Arnaud Lamamy |
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| Přispěvatelé: | AII - Amsterdam institute for Infection and Immunity, Medical Microbiology and Infection Prevention, CS533 Study Participants, Huang, X., Nguyen, J., Wall, D., Hargrove, S., Fu, T., Xu, G., Li, L., Cote, C., Delwart, E., 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. |
| Jazyk: | angličtina |
| Předmět: |
0301 basic medicine
Deep sequencing SAMPLES POLIOVIRUS Research & Experimental Medicine Adventitious virus Collaborative study 11 Medical and Health Sciences Vaccines CS533 Study Participants High-Throughput Nucleotide Sequencing Reference Standards 3. Good health CONTAMINATION Infectious Diseases Medicine Research & Experimental Viruses Molecular Medicine Biological Products/standards Drug Contamination/prevention & control Laboratories Vaccines/standards Viruses/isolation & purification Drug Contamination Life Sciences & Biomedicine Immunology Biology Article Virus PORCINE CIRCOVIRUS 03 medical and health sciences Virology 07 Agricultural and Veterinary Sciences Immunology and Microbiology(all) INFECTIVITY Reference standards PATHOGENS Biological Products Science & Technology IDENTIFICATION General Immunology and Microbiology General Veterinary Public Health Environmental and Occupational Health 06 Biological Sciences veterinary(all) Virus detection 030104 developmental biology DISCOVERY CELLS Reference material Vaccine RIBONUCLEIC ACID |
| Zdroj: | Vaccine Vaccine, 34(17), 2035-2043. Elsevier BV Vaccine, vol. 34, no. 17, pp. 2035-2043 |
| ISSN: | 0264-410X |
| DOI: | 10.1016/j.vaccine.2015.12.020 |
| Popis: | Highlights • Deep sequencing has potential as an improved adventitious virus screening method. • 15 laboratories sequenced a common reagent containing 25 target viruses. • 6 viruses were detected by all lab, the remainder were detected by 4–14 labs. • A wide range of sample preparation and bioinformatics methods is currently used. • A common reference material is essential to enable results to be compared. 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. |
| Databáze: | OpenAIRE |
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