The hepatitis B virus is a dangerous infectious agent, with an estimated 300 million carriers worldwide. Therefore, developing effective vaccine production methods is essential. One such method involves the use of transgenic plants. Several factors influence foreign gene expression in transgenic plants, including the type of genes, their chromosomal location, and the promoter used. Based on these factors, various expression cassettes can be designed for transgenic plants.In this study, we designed an expression cassette for transgenic potato plants. Promoters play a crucial role, as some are tissue-specific while others are inducible. Additionally, certain elements can enhance or silence gene expression in transgenic plants. Enhancer sequences derived from plant viruses are also utilized. To increase the expression level of HBsAg in transgenic potato plants, the tobacco etch virus (TEV) 5' untranslated region and the Patatin promoter were employed. The results demonstrated that in the highest-producing transgenic plant, the expression level of HBsAg increased threefold when both patatin and TEV were used together, compared to plants containing only the patatin promoter without TEV. Furthermore, a comparison with pCaMV combined with TEV revealed that the use of patatin and TEV resulted in a 4-5 times higher expression level.

To meet the growing demand of world’s current population for food, devising specific strategies are required. Production of genetically modified crops has been considered as a suitable strategy so that the number of countries producing GM crops rose from 29 countries in 2012 to 29 in 2013 with 175.2 million hectare cultivation area. Among the developed GM crops, Bt crops with more than 24 million ha cultivation area have been accepted greatly. Although they offer too many advantages, concerns regarding biosafety issues exist. However, no report against the of undesirable effects of GM crops exists, risk assessment of certain concerns relating to biosafety of Bt crops is necessary. Some of these concerns include risk to non-target organisms, persistence of Bt residue in Soil, acquisition of weediness potential, monoculture and eventual loss of biodiversity, unintended effects of gene transfer on plant metabolism and gene flow from Bt transgenic crops. The present reviews emphasis the considered concerns in relation to Bt transgenic crops, their assessment and management that can be used by policy maker or experts.