An integral approach towards a practical application for a plant-made monoclonal antibody in vaccine purification.
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.
Pujol
Merardo
M
Centre for Genetic Engineering and Biotechnology, A.P. 6162, C.P. 10600, Havana, Cuba. merardo.pujol@cigb.edu.cu
Ramírez
Nadia I
NI
Ayala
Marta
M
Gavilondo
Jorge V
JV
Valdés
Rodolfo
R
Rodríguez
Meilyn
M
Brito
José
J
Padilla
Sigifredo
S
Gómez
Leonardo
L
Reyes
Biunaiky
B
Peral
Rudy
R
Pérez
Marlene
M
Marcelo
José L
JL
Milá
Lorely
L
Sánchez
Rafael F
RF
Páez
Rolando
R
Cremata
José A
JA
Enríquez
Gil
G
Mendoza
Otto
O
Ortega
Mercedes
M
Borroto
Carlos
C
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*
D000911:Antibodies, Monoclonal; D014614:Vaccines, Synthetic