1887

Abstract

Ensuring the virological safety of biologicals is challenging due to the risk of viral contamination of raw materials and cell banks, and exposure during in-process handling to known and/or emerging viral pathogens. Viruses may contaminate raw materials and biologicals intended for human or veterinary use and remain undetected until appropriate testing measures are employed. The outbreak and expansive spread of the mosquito-borne flavivirus Zika virus (ZIKV) poses challenges to screening human- and animal -derived products used in the manufacture of biologicals. Here, we report the results of an in vitro study where detector cell lines were challenged with African and Asian lineages of ZIKV. We demonstrate that this pathogen is robustly detectable by in vitro assay, thereby providing assurance of detection of ZIKV, and in turn underpinning the robustness of in vitro virology assays in safety testing of biologicals.

Loading

Article metrics loading...

/content/journal/jgv/10.1099/jgv.0.000995
2017-12-14
2019-12-15
Loading full text...

Full text loading...

/deliver/fulltext/jgv/99/2/219.html?itemId=/content/journal/jgv/10.1099/jgv.0.000995&mimeType=html&fmt=ahah

References

  1. Saker L, Lee K, Cannito B, Gilmore A, Campbell-Lendrum D. Globalization and infectious diseases, a review of the linkages. UNDP/World Bank/WHO Special Programme on Tropical Diseases Research. Geneva 2004; pp1–62
  2. Howard CR, Fletcher NF. Emerging virus diseases: can we ever expect the unexpected?. Emerg Microbes Infect 2012;1:e46 [CrossRef][PubMed]
    [Google Scholar]
  3. Woolhouse ME, Gowtage-Sequeria S. Host range and emerging and reemerging pathogens. Emerg Infect Dis 2005;11:1842–1847 [CrossRef][PubMed]
    [Google Scholar]
  4. Weaver SC. Urbanization and geographic expansion of zoonotic arboviral diseases: mechanisms and potential strategies for prevention. Trends Microbiol 2013;21:360–363 [CrossRef][PubMed]
    [Google Scholar]
  5. European Medicines Agency ICH Topic Q 7 good manufacturing practice for active pharmaceutical ingredients. CPMP/ICH/4106/00 2000
  6. Aliota MT, Bassit L, Bradrick SS, Cox B, Garcia-Blanco MA et al. Zika in the Americas, year 2: what have we learned? what gaps remain? a report from the global virus network. Antiviral Res 2017;144:223–246 [CrossRef][PubMed]
    [Google Scholar]
  7. Gatherer D, Kohl A. Zika virus: a previously slow pandemic spreads rapidly through the Americas. J Gen Virol 2016;97:269–273 [CrossRef][PubMed]
    [Google Scholar]
  8. Nugent EK, Nugent AK, Nugent R, Nugent K. Zika Virus: Epidemiology, Pathogenesis and Human Disease. Am J Med Sci 2017;353:466–473 [CrossRef][PubMed]
    [Google Scholar]
  9. Wang A, Thurmond S, Islas L, Hui K, Hai R. Zika virus genome biology and molecular pathogenesis. Emerg Microbes Infect 2017;6:e13 [CrossRef][PubMed]
    [Google Scholar]
  10. European Centre for Disease Prevention and Control Zika virus epidemic in the Americas: potential association with microcephaly and Guillain-Barré syndrome, 10 December 2015. Ecdc2015:1–14
    [Google Scholar]
  11. Rodriguez-Morales AJ. Zika: the new arbovirus threat for Latin America. J Infect Dev Ctries 2015;9:684 [CrossRef][PubMed]
    [Google Scholar]
  12. McCarthy M. First US case of Zika virus infection is identified in Texas. BMJ 2016;352:i212 [CrossRef][PubMed]
    [Google Scholar]
  13. Zammarchi L, Tappe D, Fortuna C, Remoli ME, Günther S et al. Zika virus infection in a traveller returning to Europe from Brazil, March 2015. Euro Surveill 2015;20:21153–21156 [CrossRef][PubMed]
    [Google Scholar]
  14. Mlakar J, Korva M, Tul N, Popović M, Poljšak-Prijatelj M et al. Zika virus associated with microcephaly. N Engl J Med 2016;374:951–958 [CrossRef][PubMed]
    [Google Scholar]
  15. Rather IA, Lone JB, Bajpai VK, Park Y-H. Zika virus infection during pregnancy and congenital abnormalities. Front Microbiol 2017;8:1–7 [CrossRef]
    [Google Scholar]
  16. Morrison TE, Diamond MS. Animal models of zika virus infection, pathogenesis, and immunity. J Virol 2017;91:e00009-17 [CrossRef][PubMed]
    [Google Scholar]
  17. Krauer F, Riesen M, Reveiz L, Oladapo OT, Martínez-Vega R et al. Zika virus infection as a cause of congenital brain abnormalities and guillain-barré syndrome: systematic review. PLoS Med 2017;14:e1002203 [CrossRef][PubMed]
    [Google Scholar]
  18. Haddow AD, Schuh AJ, Yasuda CY, Kasper MR, Heang V et al. Genetic characterization of Zika virus strains: geographic expansion of the Asian lineage. PLoS Negl Trop Dis 2012;6:e1477 [CrossRef][PubMed]
    [Google Scholar]
  19. Ioos S, Mallet HP, Leparc Goffart I, Gauthier V, Cardoso T et al. Current Zika virus epidemiology and recent epidemics. Med Mal Infect 2014;44:302–307 [CrossRef][PubMed]
    [Google Scholar]
  20. Hayes EB. Zika virus outside Africa. Emerg Infect Dis 2009;15:1347–1350 [CrossRef][PubMed]
    [Google Scholar]
  21. Bueno MG, Martinez N, Abdalla L, Duarte dos Santos CN, Chame M. Animals in the Zika virus life cycle: what to expect from Megadiverse Latin American Countries. PLoS Negl Trop Dis 2016;10:e0005073 [CrossRef][PubMed]
    [Google Scholar]
  22. Buechler CR, Bailey AL, Weiler AM, Barry GL, Breitbach ME et al. Seroprevalence of Zika virus in wild African green monkeys and baboons. mSphere 2017;2:e00392-16 [CrossRef][PubMed]
    [Google Scholar]
  23. Phillips JA, Neyland A. Zika Virus. Work Heal Saf 2016;64:396 [CrossRef]
    [Google Scholar]
  24. Musso D, Roche C, Robin E, Nhan T, Teissier A et al. Potential sexual transmission of Zika virus. Emerg Infect Dis 2015;21:359–361 [CrossRef][PubMed]
    [Google Scholar]
  25. Mansuy JM, Dutertre M, Mengelle C, Fourcade C, Marchou B et al. Zika virus: high infectious viral load in semen, a new sexually transmitted pathogen?. Lancet Infect Dis 2016;16:405 [CrossRef][PubMed]
    [Google Scholar]
  26. Patiño-Barbosa AM, Medina I, Gil-Restrepo AF, Rodriguez-Morales AJ. Zika: another sexually transmitted infection?. Sex Transm Infect 2015;91:359 [CrossRef][PubMed]
    [Google Scholar]
  27. Musso D, Nhan T, Robin E, Roche C, Bierlaire D et al. Potential for Zika virus transmission through blood transfusion demonstrated during an outbreak in French Polynesia, November 2013 to February 2014. Euro Surveill 2014;19:20761–20766 [CrossRef][PubMed]
    [Google Scholar]
  28. Lanteri MC, Kleinman SH, Glynn SA, Musso D, Keith Hoots W et al. Zika virus: a new threat to the safety of the blood supply with worldwide impact and implications. Transfusion 2016;56:1907–1914 [CrossRef][PubMed]
    [Google Scholar]
  29. Nogueira ML, Estofolete CF, Terzian AC, Mascarin do Vale EP, da Silva RC et al. Zika virus infection and solid organ transplantation: a new challenge. Am J Transplant 2017;17:791–795 [CrossRef][PubMed]
    [Google Scholar]
  30. Besnard M, Lastere S, Teissier A, Cao-Lormeau V, Musso D. Evidence of perinatal transmission of Zika virus, French Polynesia, December 2013 and February 2014. Euro Surveill 2014;19:pii: 20751 [CrossRef][PubMed]
    [Google Scholar]
  31. Musso D, Roche C, Nhan TX, Robin E, Teissier A et al. Detection of Zika virus in saliva. J Clin Virol 2015;68:53–55 [CrossRef][PubMed]
    [Google Scholar]
  32. Barjas-Castro ML, Angerami RN, Cunha MS, Suzuki A, Nogueira JS et al. Probable transfusion-transmitted Zika virus in Brazil. Transfusion 2016;56:1684–1688 [CrossRef][PubMed]
    [Google Scholar]
  33. Zhang FC, Li XF, Deng YQ, Tong YG, Qin CF. Excretion of infectious Zika virus in urine. Lancet Infect Dis 2016;16:641–642 [CrossRef][PubMed]
    [Google Scholar]
  34. Hirsch AJ, Smith JL, Haese NN, Broeckel RM, Parkins CJ et al. Zika Virus infection of rhesus macaques leads to viral persistence in multiple tissues. PLoS Pathog 2017;13:e1006219 [CrossRef][PubMed]
    [Google Scholar]
  35. European Medicines Agency Guideline on plasma-derived medicinal products. EMA Guidel 2010;44:1–11
    [Google Scholar]
  36. EMA(CHMP) Guideline on the adventitious agent safety of urine- derived medicinal products. Draft 2013;44:1–6
    [Google Scholar]
  37. FDA 2016; Revised recommendations for reducing the risk of Zika virus transmission by blood and blood components. Guidance for industryhttp://www.fda.gov/BiologicsBloodVaccines/Guidance
    [Google Scholar]
  38. ECDC Zika virus and safety of substances of human origin. ECDC Sci Advice 2016
    [Google Scholar]
  39. Hoogstfcaal H, Roberts TJ, Ahmed IP. A sero-epidemiological survey for certain in Pakistan arboviruses (Togaviridae). 1983;77442–445
  40. Olson JG, Ksiazek TG, Gubler DJ, Lubis SI, Simanjuntak G et al. A survey for arboviral antibodies in sera of humans and animals in Lombok, Republic of Indonesia. Ann Trop Med Parasitol 1983;77:131–137 [CrossRef][PubMed]
    [Google Scholar]
  41. Chan JF, Yip CC, Tsang JO, Tee KM, Cai JP et al. Differential cell line susceptibility to the emerging Zika virus: implications for disease pathogenesis, non-vector-borne human transmission and animal reservoirs. Emerg Microbes Infect 2016;5:e93 [CrossRef][PubMed]
    [Google Scholar]
  42. Ph. Eur. 2.6.16 Test for extraneous agents in viral vaccines for human use. Eur Pharmacop 2017;90:
    [Google Scholar]
  43. Ph. Eur. 5.2.4 Cell cultures for the production of veterinary vaccines. 2017
  44. Ilchmann A, Armstrong AA, Clayton RF. Schmallenberg virus, an emerging viral pathogen of cattle and sheep and a potential contaminant of raw materials, is detectable by classical in-vitro adventitious virus assays. Biologicals 2017;49:28–32 [CrossRef][PubMed]
    [Google Scholar]
  45. Zmurko J, Marques RE, Schols D, Verbeken E, Kaptein SJ et al. The viral polymerase inhibitor 7-Deaza-2'-C-Methyladenosine is a potent inhibitor of in vitro zika virus replication and delays disease progression in a robust mouse infection model. PLoS Negl Trop Dis 2016;10:e0004695 [CrossRef][PubMed]
    [Google Scholar]
  46. Barr KL, Anderson BD, Prakoso D, Long MT. Working with Zika and Usutu viruses in vitro. PLoS Negl Trop Dis 2016;10:e0004931 [CrossRef][PubMed]
    [Google Scholar]
  47. FDA Guidance for Industry Cell Substrates and Other Biological. 2010
  48. Ph. Eur. 5.2.3. Cell Substrates for the Production of Vaccines for Human Use. 2017
  49. WHO Recommendations for the evaluation of animal cell cultures as substrates for the manufacture of biological medicinal products and for the characterization of cell banks. Who 2010
    [Google Scholar]
  50. European Medicines Agency ICH Topic Q 5 D Quality of Biotechnological Products: Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products. 1998
  51. Donald CL, Brennan B, Cumberworth SL, Rezelj VV, Clark JJ et al. Full genome sequence and sfrna interferon antagonist activity of Zika virus from Recife, Brazil. PLoS Negl Trop Dis 2016;10:e0005048 [CrossRef][PubMed]
    [Google Scholar]
  52. Porterfield JS. Use of goose cells in haemagglutination tests with arthropod-borne viruses. Nature 1957;180:1201–1202 [CrossRef][PubMed]
    [Google Scholar]
  53. Hahon N, Booth JA, Eckert HL. Quantitative assessment of hemadsorption by myxoviruses: virus hemadsorption assay. Appl Microbiol 1973;25:595–600
    [Google Scholar]
  54. Setoh YX, Prow NA, Peng N, Hugo LE, Devine G et al. De novo generation and characterization of new Zika virus isolate using sequence data from a microcephaly case. mSphere 2017;2:e00190-17 [CrossRef][PubMed]
    [Google Scholar]
  55. Simonin Y, Loustalot F, Desmetz C, Foulongne V, Constant O et al. Zika virus strains potentially display different infectious profiles in human neural cells. EBioMedicine 2016;12:161–169 [CrossRef][PubMed]
    [Google Scholar]
  56. Sheets R. History and characterization of the vero cell line. Cent Biol Eval Res (CBER); Vaccines Relat Biol Prod Advis Comm Meet 2000;1–12
    [Google Scholar]
  57. Kinney RM, Huang CY, Rose BC, Kroeker AD, Dreher TW et al. Inhibition of dengue virus serotypes 1 to 4 in vero cell cultures with morpholino oligomers inhibition of dengue virus serotypes 1 to 4 in vero cell cultures with morpholino oligomers. 2005;795116–5128
  58. Way JH, Bowen ET, Platt GS. Comparative studies of some African arboviruses in cell culture and in mice. J Gen Virol 1976;30:123–130 [CrossRef][PubMed]
    [Google Scholar]
  59. EU Horizon 2020-funded ZIK Alliance consortium. n.d;www.zikalliance.eu/
  60. www.gov.uk. Public Health England Introd to PHE Heal Wellbeing Dir. 2013;5www.yhpho.org.uk/default.aspx?RID=8504
http://instance.metastore.ingenta.com/content/journal/jgv/10.1099/jgv.0.000995
Loading
/content/journal/jgv/10.1099/jgv.0.000995
Loading

Data & Media loading...

Most Cited This Month

This is a required field
Please enter a valid email address
Approval was a Success
Invalid data
An Error Occurred
Approval was partially successful, following selected items could not be processed due to error