Screening for viral extraneous agents in live-attenuated avian vaccines by using a microbial microarray and sequencing

Screening for viral extraneous agents in live-attenuated avian vaccines by using a microbial microarray and sequencing

The absence of extraneous agents (EA) in the raw material used for production and in finished products is one of the principal safety elements related to all medicinal products of biological origin, such as live-attenuated vaccines. The aim of this study was to investigate the applicability of the L...

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Bibliographic Details
Published in:Biologicals Vol. 51; pp. 37 - 45
Main Authors: Olesen, Majken Lindholm, Jørgensen, Lotte Leick, Blixenkrone-Møller, Merete, Sandberg, Eva, Frandsen, Peer Lyng, Østergaard, Erik, Bækdahl, Eva Rauhe, Fridholm, Helena, Fomsgaard, Anders, Rosenstierne, Maiken Worsøe
Format: Journal Article
Language:English
Published: England Elsevier Ltd 01-01-2018
Subjects:
Avian vaccines
Extraneous agents
Microarray
Sequencing
SPF eggs
Extraneous agents
Microarray
Avian vaccines
SPF eggs
Sequencing
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Summary:The absence of extraneous agents (EA) in the raw material used for production and in finished products is one of the principal safety elements related to all medicinal products of biological origin, such as live-attenuated vaccines. The aim of this study was to investigate the applicability of the Lawrence Livermore Microbial detection array version 2 (LLMDAv2) combined with whole genome amplification and sequencing for screening for viral EAs in live-attenuated vaccines and specific pathogen-free (SPF) eggs. We detected positive microarray signals for avian endogenous retrovirus EAV-HP and several viruses belonging to the Alpharetrovirus genus in all analyzed vaccines and SPF eggs. We used a microarray probe mapping approach to evaluate the presence of intact retroviral genomes, which in addition to PCR analysis revealed that several of the positive microarray signals were most likely due to cross hybridization with the EAV-HPΔpol and ALV-E ev1, ev3 and ev6 loci sequences originating from the chicken genome. Sequencing of the vaccines on a MiSeq instrument verified the microarray findings and showed similar cross hybridization. Our results suggest that genomic microarrays and sequencing of avian attenuated vaccines may be applied in tests for EA.
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ISSN:1045-1056
1095-8320
DOI:10.1016/j.biologicals.2017.10.005