perceptions of agricultural biotechnology specific to producing novel vaccines and
pharmaceuticals is needed before substantive generalizations can be made. Given
that (1) oral pharmaceuticals are preferred, (2) people believe that most vaccines are
genetically modified, and (3) public has expressed a high acceptance for PMPs,
further development of this technology by commercial parties is desirable, if
paralleled with appropriate market demand for specific products. Investment in
clear communication by scientists and regulators will further enhance the public
trust, optimism and ultimate acceptance for PMPs.
Even though the first players that tried to move the border forward were academia
and public parties, due to the commercial uncertainties caused by production processes in the absence of certain regulations, nevertheless Elelyso is a positive
example of how interest and engagement of a company can generate a big value
for citizen’s health and can reassure people on the possibility to get profit of some
pharmaceuticals that are “biobetters by nature” due to the plant origin.
Even if the probability and severity of risks is different between open-field
production for food and pharmaceutically based GMP production, depends on the
plant species and has to be determined on a case-by-case basis for each plant-based
product, the evidences of harmlessness of GM crops used for food supply may
probably help to communicate to end-users the intrinsic safety of plant-produced
biopharmaceuticals for both people and environment. As an example, meta-analysis
of 21 years of open-field data (from 1996 to 2016) on the impact of genetically
engineered maize clearly demonstrated the fulfilment of the desired effects on the
target insect, no substantial effect on insect community diversity, reduced health
risks for human consumption (due to relevant reduction of mycotoxin content in
grains) and improved quality of the production (Pellegrino et al. 2018).
Reaching citizens and stakeholders with correct and peer-reviewed scientific
information should finally clear both risks and benefits related to genetically
engineered plants and reduce debate, hopefully. As gene technology moves forward,
new traits and new health properties will be conferred to plants, and new experimental data should be available allowing researchers and regulators to draw further
conclusions on the agro-environmental and health risks of GE plants.
7 Conclusions
Platforms for PMP are different and may involve the use of whole plants in
greenhouses, vertical farming facilities or plant cell/organ cultures subjected to a
transient or stable expression (targeted or constitutive). In addition, the unaltered
version of the engineered plant may be a food or feed crop, or neither. Expression
may involve transgene(s) vehiculation into nuclear or organelle genome resulting in
protein monomers, multimers or virus-like particles. The PMP may be intended for
purification, or administration as a crude extract or whole-plant tissue with a route
of administration may be parenteral oral, nasal or topical. All these aspects may
emphasize the advantages of the plant-based system but also influence the steps
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