Abstract
(Englisch)
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Plants are attractive vehicles for the expression of recombinant pharmaceutical proteins as they are inexpensive and versatile systems, amenable to rapid and economical scale-up. Public opinion in Europe is generally negative towards GM plants, which has led to the loss of many SMEs and commercial development from the Union. However, the use of GM plants for medicines and vaccines rates very highly in terms of public acceptance. With this proposal, our primary aim is to build on previous proof-of-concept studies to develop pharmaceutical products through to clinical trials. The use of GM pharmaceuticals has precedents, such as human insulin and hepatitis B vaccine, but plant derived materials used in humans has not been formally addressed within the EU. A major outcome will be to define the regulatory requirements through a process of engagement and consultation with all relevant regulatory bodies (involved in GM plants as well as new pharmaceuticals), in order to move through clinical trials and gain permission for the use of plant derived pharmaceuticals in practice. Monoclonal antibodies will be the first generation of molecules to be developed for Phase I clinical evaluation, and we include 2 neutralising antibodies each for HIV and rabies. The proposal also includes a limited range of other targets, against HIV, TB and diabetes, and for some of these, new expression strategies will need to be developed. They represent the second-generation molecules which will feed the development pipeline for SMEs in Europe, beyond the lifetime of the project. In each case, plant-based systems offer a real advantage, if not the only option for production on a scale relevant to the needs for that molecule.
Alongside our principle aim of developing plant derived recombinant pharmaceuticals, we recognise the need to put in place comprehensive risk assessments based on health and environmental impacts, and to work with EU regulatory authorities to ensure GM plant production.
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