EMA published a draft guidance on the quality of the biologically active substances produced by stable transgene expression in higher plants, which only goes
through plants with stable expression of transgenes and does not consider transiently
transfected plants and/or plant cell cultures, the use of which still requires regulation.
EMA states the importance of the establishment of master and working seed banks
from the final transformant that have to be characterized in respect to the transgene
(i.e. sequence, integrity, site of insertion, copy number, fate of the marker sequence),
recombinant protein expression (i.e. tissue and organ specificity, regulation, expression level) and unintended changes in the levels of endogenous plant proteins and
storage properties (storage conditions, shelf-life). Importantly, EMA regulatory
guidelines indicate that all biopharmaceutical products in trials should be
manufactured according to GMP (European Medicines Agency. Guideline on the
Quality of Biological Active Substances Produced by Stable Transgene Expression
in Higher Plants www.ema.europa.eu/docs/en_GB/document_library/Scientific_
guideline/2009/09/WC500003154.pdf).
The Pharma-Planta Consortium (including 33 academic and companies in Europe
and South Africa), funded by the CE Framework Programme 6, was the first entity to
be engaged with regulatory authorities in this field, from 2004 to 2011. Great merit
should be attributed to this consortium that significantly contributes to the maturation of the EMA guidelines in this research area (as summarized previously in the
text). As a consequence, a GMP manufacturing license (i.e. for the above-mentioned
anti-HIV antibody P2G12) was granted to Fraunhofer IME for plant-derived monoclonal antibodies by the Germany regulatory authority and subsequent clinical trials
application approved by the UK regulatory authority. These two achievements
demonstrated that a GMP-compliant process for transgenic plants and the administration of a plant-made recombinant biopharmaceutical were feasible and acceptable
to regulators throughout Europe (Ma et al. 2015).
6.3 Acceptance and Inclusion of Citizens in the Decisional
Processes
Today, the users of products are increasingly active and engaged consumers, especially when goods are relevant to their health. People are more and more aware of the
consequences of health effects, and it is fundamental to be responding to people’s
expectations. The vast majority of consumers agree that development in science
and technology could make changes to their lives too quickly and that they may hide
negative side effects on both health and environment (Castle and Dalgleish 2005).
Social and environmental impacts are increasingly complex, and it is necessary to
demonstrate that any research is ethically, socially and environmentally responsible.
Biotechnology innovations, certainly successful on technical merits, must also be
accompanied by social acceptance, assuming that market demand is favourable for a
94
S. Massa et al.
through plants with stable expression of transgenes and does not consider transiently
transfected plants and/or plant cell cultures, the use of which still requires regulation.
EMA states the importance of the establishment of master and working seed banks
from the final transformant that have to be characterized in respect to the transgene
(i.e. sequence, integrity, site of insertion, copy number, fate of the marker sequence),
recombinant protein expression (i.e. tissue and organ specificity, regulation, expression level) and unintended changes in the levels of endogenous plant proteins and
storage properties (storage conditions, shelf-life). Importantly, EMA regulatory
guidelines indicate that all biopharmaceutical products in trials should be
manufactured according to GMP (European Medicines Agency. Guideline on the
Quality of Biological Active Substances Produced by Stable Transgene Expression
in Higher Plants www.ema.europa.eu/docs/en_GB/document_library/Scientific_
guideline/2009/09/WC500003154.pdf).
The Pharma-Planta Consortium (including 33 academic and companies in Europe
and South Africa), funded by the CE Framework Programme 6, was the first entity to
be engaged with regulatory authorities in this field, from 2004 to 2011. Great merit
should be attributed to this consortium that significantly contributes to the maturation of the EMA guidelines in this research area (as summarized previously in the
text). As a consequence, a GMP manufacturing license (i.e. for the above-mentioned
anti-HIV antibody P2G12) was granted to Fraunhofer IME for plant-derived monoclonal antibodies by the Germany regulatory authority and subsequent clinical trials
application approved by the UK regulatory authority. These two achievements
demonstrated that a GMP-compliant process for transgenic plants and the administration of a plant-made recombinant biopharmaceutical were feasible and acceptable
to regulators throughout Europe (Ma et al. 2015).
6.3 Acceptance and Inclusion of Citizens in the Decisional
Processes
Today, the users of products are increasingly active and engaged consumers, especially when goods are relevant to their health. People are more and more aware of the
consequences of health effects, and it is fundamental to be responding to people’s
expectations. The vast majority of consumers agree that development in science
and technology could make changes to their lives too quickly and that they may hide
negative side effects on both health and environment (Castle and Dalgleish 2005).
Social and environmental impacts are increasingly complex, and it is necessary to
demonstrate that any research is ethically, socially and environmentally responsible.
Biotechnology innovations, certainly successful on technical merits, must also be
accompanied by social acceptance, assuming that market demand is favourable for a
94
S. Massa et al.