The mission of the Pharma-Planta Consortium is to develop efficient and safe strategies for the production of clinical-grade protein pharmaceuticals in plants, and to define the procedures needed for the production of these proteins in compliance with the strict regulatory standards that govern the manufacture of all pharmaceuticals. Ultimately we seek to take a candidate product all the way through the development pipeline culminating in a phase I human clinical trial.
The specific objectives listed at the beginning of the Pharma-Planta project can be summarized as follows:
1. To produce a recombinant pharmaceutical molecule in transgenic plants, which will be developed through all regulatory requirements, GMP standards and pre-clinical toxicity testing. This will then be evaluated in Phase I human clinical trials.
2. To develop robust risk assessment practices for recombinant pharmaceutical molecules produced in plants, based on health and environmental impact, working with regulatory authorities within the EU as well as public groups to ensure that the production systems are as safe and as acceptable as possible, and that they comply with all biosafety regulations.
3. To define and carry out a coordinated program for securing and managing intellectual property that will facilitate the availability of high priority plant-derived recombinant pharmaceuticals to the poor in developing countries while simultaneously allowing the products to be developed commercially in Europe and North America.
4. To develop and refine new strategies for the expression of recombinant pharmaceuticals in plants, which can be used on a generic basis for molecules that are normally expressed poorly.
5. To develop and generate transgenic plants expressing a second generation of recombinant molecules that will be used in future clinical trials.