title: An integral approach towards a practical application for a plant-made monoclonal antibody in vaccine purification.
abstract: The use of transgenic plants for the production of pharmaceutical compounds has received increasing attention in the last few years. However, many technological and regulatory issues regarding the practical exploitation of this alternative system of production remain to be solved; a situation that explains the lack of commercial products derived from such a system. This paper reports the expression in transgenic plants and cells of a single-chain antibody variable-region fragment (scFv) and a mouse monoclonal antibody to the hepatitis B virus surface antigen (HBsAg). The large-scale purification of the scFv from plants and its use for immunopurification of HBsAg are also described, together with elements concerning regulatory issues and technologies for compliance with good manufacturing and agricultural practices.
authors.affiliation: Centre for Genetic Engineering and Biotechnology, A.P. 6162, C.P. 10600, Havana, Cuba. merardo.pujol@cigb.edu.cu
authors.forename: Merardo
authors.initials: M
authors.lastname: Pujol
authors.forename: Nadia I
authors.initials: NI
authors.lastname: Ramírez
authors.forename: Marta
authors.initials: M
authors.lastname: Ayala
authors.forename: Jorge V
authors.initials: JV
authors.lastname: Gavilondo
authors.forename: Rodolfo
authors.initials: R
authors.lastname: Valdés
authors.forename: Meilyn
authors.initials: M
authors.lastname: Rodríguez
authors.forename: José
authors.initials: J
authors.lastname: Brito
authors.forename: Sigifredo
authors.initials: S
authors.lastname: Padilla
authors.forename: Leonardo
authors.initials: L
authors.lastname: Gómez
authors.forename: Biunaiky
authors.initials: B
authors.lastname: Reyes
authors.forename: Rudy
authors.initials: R
authors.lastname: Peral
authors.forename: Marlene
authors.initials: M
authors.lastname: Pérez
authors.forename: José L
authors.initials: JL
authors.lastname: Marcelo
authors.forename: Lorely
authors.initials: L
authors.lastname: Milá
authors.forename: Rafael F
authors.initials: RF
authors.lastname: Sánchez
authors.forename: Rolando
authors.initials: R
authors.lastname: Páez
authors.forename: José A
authors.initials: JA
authors.lastname: Cremata
authors.forename: Gil
authors.initials: G
authors.lastname: Enríquez
authors.forename: Otto
authors.initials: O
authors.lastname: Mendoza
authors.forename: Mercedes
authors.initials: M
authors.lastname: Ortega
authors.forename: Carlos
authors.initials: C
authors.lastname: Borroto
mesh_terms: D016960:Agrobacterium tumefaciens / Q000276:immunology; D000818:Animals; D000911:Antibodies, Monoclonal / Q000096:biosynthesis* / Q000302:isolation & purification*; D006801:Humans; D030821:Plants, Genetically Modified / Q000276:immunology* / Q000378:metabolism; D014614:Vaccines, Synthetic / Q000096:biosynthesis* / Q000302:isolation & purification*
chemical_list: D000911:Antibodies, Monoclonal; D014614:Vaccines, Synthetic