Article thumbnail

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

By ET Mee, MD Preston, CSSS Participant, PD Minor and S Schepelmann

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

Topics: 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, Adventitious virus, Collaborative study, Deep sequencing, Reference material, Vaccine, Biological Products, Drug Contamination, High-Throughput Nucleotide Sequencing, Laboratories, Reference Standards, Vaccines, Viruses, CS533 Study Participants, Viruses, Biological Products, Vaccines, Drug Contamination, Reference Standards, Laboratories, High-Throughput Nucleotide Sequencing, 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, Virology, 06 Biological Sciences, 07 Agricultural and Veterinary Sciences, 11 Medical and Health Sciences
Publisher: 'Elsevier BV'
Year: 2015
DOI identifier: 10.1016/j.vaccine.2015.12.020
OAI identifier: oai:spiral.imperial.ac.uk:10044/1/81559
Journal:
Download PDF:
Sorry, we are unable to provide the full text but you may find it at the following location(s):
  • http://hdl.handle.net/10044/1/... (external link)
  • Suggested articles


    To submit an update or takedown request for this paper, please submit an Update/Correction/Removal Request.