title: Process development for a Cuban cholera vaccine based on the attenuated strain Vibrio cholerae 638.
abstract: Genetically modified Vibrio cholerae strain 638 (biotype El Tor, serotype Ogawa) has previously been shown to be immunogenic in animal models and in human trials. Our objective in the work reported herein was to describe the process development methods for the production of the 638 attenuated cholera vaccine. Cell seed bank, culture of biomass, lyophilization and final formulation were processes were developed. The results show kinetics of culture that fulfils a logistical model. The microbiological properties, colonizing capability, immunogenicity and non-toxigenicity of the final product were indistinguishable from the properties of the working seed lot. We conclude that the non-reactogenic, immunogenic and protective strain 638 is robust and can withstand the fermentation processes required for large-scale production of a vaccine.
authors.affiliation: Finlay Institute, 27 Ave, # 19805 La Lisa, Ciudad de la Habana, A.P. 16017, Cod. 11600, Cuba. atalavera@finlay.edu.cu
authors.forename: A
authors.initials: A
authors.lastname: Talavera
authors.forename: G
authors.initials: G
authors.lastname: Año
authors.forename: H
authors.initials: H
authors.lastname: García
authors.forename: T
authors.initials: T
authors.lastname: Moreira
authors.forename: H
authors.initials: H
authors.lastname: Delgado
authors.forename: L
authors.initials: L
authors.lastname: Riverón
authors.forename: S
authors.initials: S
authors.lastname: Gil
authors.forename: A
authors.initials: A
authors.lastname: Miranda
authors.forename: B
authors.initials: B
authors.lastname: Cedré
authors.forename: T
authors.initials: T
authors.lastname: Valmaseda
authors.forename: Y
authors.initials: Y
authors.lastname: Pino
authors.forename: J L
authors.initials: JL
authors.lastname: Pérez
authors.forename: J F
authors.initials: JF
authors.lastname: Infante
authors.forename: L
authors.initials: L
authors.lastname: García
authors.forename: G
authors.initials: G
authors.lastname: Sierra
mesh_terms: D000818:Animals; D002771:Cholera / Q000517:prevention & control; D002772:Cholera Toxin / Q000032:analysis; D022121:Cholera Vaccines / Q000009:adverse effects / Q000276:immunology; D004345:Drug Industry; D005285:Fermentation; D006801:Humans; D051379:Mice; D008807:Mice, Inbred BALB C; D023421:Models, Animal; D013678:Technology, Pharmaceutical; D014613:Vaccines, Attenuated / Q000009:adverse effects / Q000276:immunology; D014734:Vibrio cholerae / Q000235:genetics / Q000276:immunology* / Q000472:pathogenicity / Q000502:physiology
chemical_list: D022121:Cholera Vaccines; D014613:Vaccines, Attenuated; D002772:Cholera Toxin