Risk assesment of Nicotiana tabacum plant extracts expressing two different recombinant heterologous proteins on female Balb/c mice

MARCONI PL; GALLO CALDERON M; LANGLE Y; MARTINEZ S, ; SANJUAN P; SANJUAN N; BENAVIDES MP; ALVAREZ MA

Congreso; VIII Latin-American and the Caribbean Meeting of BiotechnlogyREDBIO Argentina 2013.; 2013

Recombinant foliar extract is a new drug delivery concept to produce high-value recombinant proteins by genetic or transient modified plants. These novel crops used need deep risks-evaluations demonstrating the non-toxicity of recombinant foliar extracts in order to inform the innocuity to the public opinion. The present work takes into account the assessment of the host plant and the foliar extract injected into mice to deliver plant made heterologous proteins. Mice Balb/c were subcutaneously immunized administering foliar extracts from genetic modified plant expressing the full antibody r14D9 or the glycoprotein tE2 transiently express, both formulated with the complete Freund?s adjuvant. Three boosters were applied with the each foliar extract. Other experiments were driven with Al(OH)3- Hydrogel® adjuvant as described above. Also, control animals were primed and boosted with wild type tobacco foliar extract plus each one of the two adjuvants (control vaccine). No significant differences were observed between the injections of foliar extracts. In all cases, the classic pathology caused by inflammatory processes triggered by adjuvants was obtained in all mice injected. The histological sections of the injection sites as well as the main organs showed no signs of alterations or defects. Clinical and haematological tests support the observations described previously.