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dc.contributor.author
Spitteler, Marcelo A.
dc.contributor.author
Romo, Ana
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Magi, Nicolás
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Seo, Min Goo
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Yun, Seon-Jong
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Barroumeres, Fernando
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Régulier, Emmanuel G.
dc.contributor.author
Bellinzoni, Rodolfo
dc.date.available
2021-03-10T15:44:37Z
dc.date.issued
2019-08
dc.identifier.citation
Spitteler, Marcelo A.; Romo, Ana; Magi, Nicolás; Seo, Min Goo; Yun, Seon-Jong; et al.; Validation of a high performance liquid chromatography method for quantitation of foot-and-mouth disease virus antigen in vaccines and vaccine manufacturing; Elsevier; Vaccine; 37; 36; 8-2019; 5288-5296
dc.identifier.issn
0264-410X
dc.identifier.uri
http://hdl.handle.net/11336/127970
dc.description.abstract
Foot-and-mouth disease (FMD) is an infectious viral disease that affects the main meat and dairy production animals, including cattle, sheep, goats and swine. It is readily transmissible and countries where the disease is present suffer harsh international trade restrictions on livestock products and serious economic losses. Vaccines are important tools to contain outbreaks and maintain the status of free with or without vaccination, as defined by the World Organization for Animal Health (OIE). The efficacy of vaccines is reliant on the content and integrity of inactivated virus particles. The long-established method to quantify the viral content of vaccines along the manufacturing process and in the final product is the 140S sucrose density gradient analysis. This method has been a valuable tool for many decades. However, it requires gradient preparation for each sample, a lengthy ultracentrifugation and a manual UV reading of the gradient, rendering it highly operator dependent and almost impossible to automate. We present a method to quantify FMDV particles in vaccines and intermediate process samples that is based on separation of components by size exclusion high performance liquid chromatography (SE-HPLC) and measurement of virus by absorption at 254 nm. The method has been extensively validated; it is accurate, precise and linear. It is applicable to all FMDV strains and sample materials and has a good concordance with the 140S test. The proposed method uses off the shelf HPLC equipment and columns. It is easily automated for high throughput operation, affording a useful process analytical technology and a novel tool for control of final product by manufacturers and regulatory agencies.
dc.format
application/pdf
dc.language.iso
eng
dc.publisher
Elsevier
dc.rights
info:eu-repo/semantics/restrictedAccess
dc.rights.uri
https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
dc.subject
140S
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146S
dc.subject
FMD
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FMDV
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FOOT-AND-MOUTH-DISEASE
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GPC
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HPLC
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SE-HPLC
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SIZE EXCLUSION HIGH PERFORMANCE LIQUID CHROMATOGRAPHY
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VACCINE
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VALIDATION
dc.subject.classification
Ciencias Veterinarias
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Ciencias Veterinarias
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CIENCIAS AGRÍCOLAS
dc.title
Validation of a high performance liquid chromatography method for quantitation of foot-and-mouth disease virus antigen in vaccines and vaccine manufacturing
dc.type
info:eu-repo/semantics/article
dc.type
info:ar-repo/semantics/artículo
dc.type
info:eu-repo/semantics/publishedVersion
dc.date.updated
2021-03-05T19:00:23Z
dc.journal.volume
37
dc.journal.number
36
dc.journal.pagination
5288-5296
dc.journal.pais
Países Bajos
dc.journal.ciudad
Amsterdam
dc.description.fil
Fil: Spitteler, Marcelo A.. Biogénesis Bagó; Argentina
dc.description.fil
Fil: Romo, Ana. Biogénesis Bagó; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - La Plata; Argentina
dc.description.fil
Fil: Magi, Nicolás. Biogénesis Bagó; Argentina
dc.description.fil
Fil: Seo, Min Goo. Animal and Plant Quarantine Agency; Corea del Sur
dc.description.fil
Fil: Yun, Seon-Jong. Animal and Plant Quarantine Agency; Corea del Sur
dc.description.fil
Fil: Barroumeres, Fernando. Biogénesis Bagó; Argentina
dc.description.fil
Fil: Régulier, Emmanuel G.. Biogénesis Bagó; Argentina
dc.description.fil
Fil: Bellinzoni, Rodolfo. Biogénesis Bagó; Argentina
dc.journal.title
Vaccine
dc.relation.alternativeid
info:eu-repo/semantics/altIdentifier/url/https://www.sciencedirect.com/science/article/pii/S0264410X19309491
dc.relation.alternativeid
info:eu-repo/semantics/altIdentifier/doi/http://dx.doi.org/10.1016/j.vaccine.2019.07.051
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